Monday, July 21, 2008
BreathID for Simple Liver Disease Identification Gets FDA's Trial OK
Here's a follow up on our post from April. The FDA has given Israel's Exalenz the go-ahead to proceed with Phase III clinical trial to test the company's BreathID system for diagnosing liver disease. The device uses something called Molecular Correlation Spectroscopy which uses 12CO2 and 13CO2 discharging lamps to detect the ratio of carbon 12 and carbon 13 isotopes.
The trial will include 412 patients at 12 large medical centers in the US as well as at Hadassah Medical Organization in Jerusalem. Exalenz says that it believes that this is the largest clinical trial of its kind ever conducted by an Israeli company. The trial aims at replicating the results of the Phase II clinical trial in Israel and Europe, which was completed a few months ago.
Here's a video overview of the BreathID system:
Press release: FDA approves Exalenz Liver Trial (.pdf)...
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Tuesday, July 15, 2008
PillCam Used to Diagnose Crohn Disease
Inflammatory bowel disease (IBD) comprises a number of disorders, such as ulcerative colitis (UC) and Crohn disease (CD). A retrospective cohort study of pedi patients published in the Journal of Pediatric Gastroenterology and Nutrition has identified that capsule endoscopy can be a useful diagnostic modality in identifying the exact type of inflammatory bowel disease. The study used Given Imaging's PillCam device.
The company explains:
The retrospective cohort analysis examined the medical records of patients from ages two to 18 years of age who had been previously diagnosed with Crohn's disease, ulcerative colitis or indeterminate colitis and whose disease had flared within the previous three years, leading to capsule endoscopy. Twenty-eight (28) patients met the criteria for inclusion in the study. Key findings include:-- 71% (5/7) of patients with ulcerative or indeterminate colitis had small bowel CE findings that led to reclassification of disease (from ulcerative or indeterminate colitis to Crohn's disease), resulting in a
change in medical management.
-- 62% (13/21) of patients with Crohn's disease were found to have more extensive (more proximal) small bowel disease than previously identified, 92% of which occurred in the jejunum, suggesting that pediatric Crohn's
disease may involve the proximal small bowel more than previously reported.
-- Of those with previously unrecognized jejunal disease, 92% (11/12) of treatment regimens were altered based upon the new CE findings.
Abstract in JPGN: Capsule Endoscopy May Reclassify Pediatric Inflammatory Bowel Disease: A Historical Analysis
Press release: Study Shows That PillCam(R) SB Helps Doctors Treat Children With Crohn's Disease More Effectively
More about the PillCam from our archives...
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Wednesday, July 2, 2008
Radial Jaw 4 Biopsy Forceps From Boston Sci
Boston Scientific thinks that its endoscopic Radial Jaw 4 Biopsy Forceps, a device introduced back in July 2006, is better than all other similar products on the market. To its effect, the company touts the results of the study by Garth Swanson MD, et al from Rush University Medical Center that found that "jumbo RJ4 biopsy forceps improved tissue sampling in Barrett's Esophagus compared to standard large capacity forceps." The big idea behind the device is that it features a larger bucket and newly designed holes to allow mucus to flow from the tissue sample.
More features from the product page:
New jaw configuration is designed to provide:Large tissue specimens for sample handling, preparation and accurate histological diagnosis Jumbo: More than 1.7 X the Jaw Volume of Radial Jaw 3 Large Capacity Forceps Large Capacity: More than 1.2 X the Jaw Volume of Radial Jaw 3 Large Capacity Forceps Consistent sample retention for precise sample identification Enhanced passability through tortuous anatomy Improved micro-mesh tooth design is engineered for a clean, precise bite
New streamlined catheter is designed to provide the right balance of columnar strength and flexibility for pushability and control during scope passage
New positioning markers are engineered to assist in the insertion and withdrawal of forceps to enhance procedural safety and efficiency
Single-use design to eliminate the risk of transmitting patient-to-patient diseases
Product page: Radial Jaw® 4 Biopsy Forceps ...
Study abstract: The Effect of a New Jumbo Biopsy Forceps on Tissue Acquisition in Barrett's Esophagus (.pdf)
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Friday, June 13, 2008
Cook Medical Introduces Evolution Controlled Release Esophageal Stent System
Taking care of terminal patients with an advanced esophageal cancer is a difficult task, both from a clinical perspective and a psychological one. This new minimally invasive device from Cook Medical, called Evolution® Controlled Release Esophageal Stent System, recently granted 510(k) clearance from the FDA, should make care more compassionate, while improving the quality of life of patients.
The Evolution stent's retractable delivery system facilitates direct monitoring of the placement progress throughout the procedure with it's “point-of-no-return” indicator, allowing physicians more controlled placement of the stent. With each squeeze of the stent's trigger-based introducer, a proportional length of the stent is deployed or recaptured. The directional button enables seamless switching from deployment to recapture mode and the “point-of-no-return” mark alerts the physician when recapture is no longer available. However, even after this point repositioning is still an option.The Evolution Stent is designed with dual flanges that secure the stent, potentially reducing the risk of migration or stent movement after placement, thus eliminating the need for repeat procedures. It is also the only esophageal stent with an internal and external silicone coating, designed to resist tumor ingrowth into the stent and enhances the patients' ability to swallow food normally instead of eating through a tube.
Press release: Cook Medical Announces FDA 510(k) Clearance of Evolution® Controlled Release Esophageal Stent System
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Monday, June 9, 2008
Sedation Web Site... For Endoscopy
An internet baby has been born out of one of the biggest Gastroenterology conferences of the year, the Digestive Disease Week (DDW).
www.sedationfacts.org is an online resource on endoscopic sedation meant for gastroenterologists and GI nurses. Here's more about the website from the press release:
The collaborative effort provides an easy-to-access online body of knowledge about the science, pharmacology, practice management and regulatory environment of endoscopic sedation. This Web site aims to improve the understanding of endoscopic sedation among GI medical professionals and trainees, giving them the information they need to improve their knowledge and to ensure patient safety.
Always be sure to keep up with the latest sedation news.
Read the press release here...
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Tuesday, June 3, 2008
Is a Distally Controlled PillCam Coming?
Given Imaging, a company well known around here for its line of PillCam capsule endoscopes, is collaborating with a bunch of German institutions to develop technology to control the position and the speed of transit of its devices in the GI track.
According to Fraunhofer-Institut für Biomedizinische Technik, the research is quite promising:
Images of the inside of the intestine can be obtained even today: The patient swallows a camera that is no larger than a candy. It makes its way through the intestine and transmits images of the intestinal villi to an external receiver which the patient carries on a belt. This device stores the data so that the physician can later analyze them and identify any hemorrhages or cysts. However, the camera is not very suitable for examinations of the esophagus and the stomach. The reason is that camera only takes about three or four seconds to make its way through the esophagus – producing two to four images per second – and once it reaches the stomach, its roughly five-gram weight causes it to drop very quickly to the lower wall of the stomach. In other words, it is too fast to deliver usable images. For examinations of the esophagus and the stomach, therefore, patients still have to swallow a rather thick endoscope.In collaboration with engineers from the manufacturer Given Imaging, the Israelite Hospital in Hamburg and the Royal Imperial College in London, researchers from the Fraunhofer Institute for Biomedical Engineering in Sankt Ingbert have developed the first-ever control system for the camera pill. “In future, doctors will be able to stop the camera in the esophagus, move it up and down and turn it, and thus adjust the angle of the camera as required,” says IBMT team leader Dr. Frank Volke. “This allows them to make a precise examination of the junction between the esophagus and the stomach, for if the cardiac sphincter is not functioning properly, gastric acid comes up the esophagus and causes heartburn. In the long term, this may even cause cancer of the esophagus. Now, with the camera, we can even scan the stomach walls.” But how do the researchers manage to steer the disposable camera inside the body? “We have developed a magnetic device roughly the size of a bar of chocolate. The doctor can hold it in his hand during the examination and move it up and down the patient’s body. The camera inside follows this motion precisely,” says Volke.
The steerable camera pill is constructed in much the same way as its predecessor: It consists of a camera, a transmitter that sends the images to the receiver, a battery and several cold-light diodes which briefly flare up like a flashlight every time a picture is taken. One prototype of the camera pill has already passed its first practical test in the human body. The researchers demonstrated in a self-experiment that the camera can be kept in the esophagus for about ten minutes, even if the patient is sitting upright.
Full story: Magnet-controlled camera in the body...
Flashbacks: Given Imaging endoscopy capsules...
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Wednesday, May 21, 2008
Noninvasive Device Being Developed for Gastroesophageal Reflux Disease
Charles J. Filipi, M.D., professor of surgery at Creighton University School of Medicine, has developed an endoscopic fundoplication (?) system, dubbed Intraluminal Gastroplasty Device, that might be able to offer minimally invasive therapy options for such conditions as obesity and GERD. The device seems to be quite similar to other endoscopic fundoplication systems that we have covered before (see flashbacks below).
From the Creighton University press office:
Typically, operations for GERD or obesity are performed using incisions, which requires hospitalization and have the potential for significant complications, he said. The device, a flexible tube with a metal capsule that is 3-feet-long and less than 4/5 of an inch in diameter – avoids the need for incisions, Filipi noted.
To treat obesity, the device is introduced through the mouth and esophagus, suctioning two sides of the stomach lining into position for suturing, impaling the mucosa (stomach lining), and placing a row of stitches through the stomach’s two sides. To assist in healing, part of the inner lining of the stomach is removed, and the remaining areas are brought together by adjacent stitches to form a small stomach “pouch” that accommodates only a few bites of food. Bringing the remaining areas together for healing and scarring increases the strength of the stomach-pouch wall so it will last longer, distinguishing this procedure from other noninvasive methods that have been attempted for obesity and reflux disease.To treat GERD – a condition in which a patient’s gastroesophageal junction does not close completely and acid or bile from the stomach enters and can damage the esophagus – the device is inserted through the mouth and esophagus until it reaches the esophageal junction, the opening at the bottom of the esophagus that connects the esophagus to the stomach. A surgeon can then use the instrument to suture the esophageal junction to make it smaller. Usually two stitches are necessary on one side of the gastroesophageal junction.
The device is being developed into a product by SafeStitch Medical through a licensing agreement with Creighton University.
Press release: Creighton Researcher Reports on Noninvasive Device for GERD, Obesity...
Device info page at SafeStitch Medical: Intraluminal Gastroplasty Device - GERD ...
Flashbacks: SRS System: Endoscopic Partial Anterior Fundoplication ; EsophyX™ (Endoluminal Fundoplication™) ELF System for GERD
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Thursday, April 3, 2008
BreathID Sniffs Success, Eyes FDA Approval
Medgadget readers might recall our May, 2006 coverage of the BreathID® System, an electronic breath analysis device designed to evaluate overall liver function in patients with chronic hepatic diseases, such as hepatitis or cirrhosis. According to the latest report in the Globes:
Exalenz Bioscience Ltd. has applied to the US Food and Drug Administration (FDA) for marketing approval of the company's BreathID device following completion of a clinical trial on 500 patients.The trial was conducted at Hadassah Medical Organization in Ein Kerem, Kings College in London, and in Zurich. The trial aimed at diagnosing liver damage caused by cirrhosis and hepatic impairment. The BreathID diagnostic device achieved 90% accuracy compared with biopsies, which are considered the "gold standard".
Going back to the basics, here's an overview of the BreathID technology:
The BreathID System is a revolutionary platform capable of assessing a range of liver and gastrointestinal disorders via molecular analysis of the patient's exhaled breath. The system is the only breath-testing technology that provides continuous, automatic and real-time patient monitoring and data analysis. BreathID uses a clinically proven, sophisticated laser-like light source to pinpoint real-time changes in 13C/12C isotope ratios at an accuracy level of single parts per million. It is a paradigm change in the way liver and GI disorders are assessed and managed. Covered by more than 60 patents and patent applications worldwide, the BreathID system is one of the most versatile and advanced diagnostic platforms for hepatologists and gastroenterologists in today`s medical environment.BreathID® is a proven, breath-testing system that incorporates a number of proprietary core technologies - such as Microstream®, MCS™ (Molecular Correlation Spectroscopy), CRT™ (Continuous Real Time) and online analysis algorithms that are protected by a series of patents and patent applications.
The BreathID combination of advanced technologies allows for automatic, continuous and real-time breath sampling and analysis. This ensures highly accurate results and the shortest possible test duration. Moreover, the system is portable so that tests can be conducted in any clinical setting.
BreathID Technology Process
Product page: BreathID Technology...
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Wednesday, March 19, 2008
Endo-microscopy Technique Shows Promise for Early Colon CA Diagnosis
Back in June 2007 we profiled an endo-microscopy system from Paris-based Mauna Kea Technologies. To remind our readers, this company's main product, the Cellvizio® fibered confocal microscopy system, allows a "practitioner to insert one of the miniprobes (only 300 um to 2.8 mm in diameter) into a conventional endoscope and record microscopic level movies of the tissue as fast as 12 frames/sec."
The latest news is that Stanford University scientists tested the system in a small study, to evaluate the detection of early stages of colon cancer, and they were quite pleased with the results:
Doctors may one day be able to detect early stages of colon cancer without a biopsy, using a new technique developed by researchers at the Stanford University School of Medicine.This imaging technology is one of many new ways of detecting cancers in the body in real time, said Christopher Contag, PhD, associate professor of pediatrics and of microbiology and of immunology, who led the study. Contag said he hoped it might be one of the first to be used routinely for early detection of cancer.
“Detecting colon cancers is just the first step,” said Contag. He predicted similar techniques will eventually be able to find a wide range of cancers, monitor cancer treatment, and deliver chemotherapies directly to cancerous cells in the colon, stomach, mouth and skin. The study is published online in Nature Medicine...
If doctors find suspicious growths during a routine colonoscopy, they take a sample, called a biopsy, and send it to a pathology lab to screen for cancer. That step takes time and not all people have ready access to a nearby pathologist. What’s more, doctors biopsy only the cancers that form easily visible growths called polyps. Early stage cancers that remain flat aren’t detected.The trick to picking up cancer without a biopsy is to find a way of seeing which cells are cancerous while they are still in the body. That’s what Contag and his group succeeded in doing.
The group found a short protein that sticks to colon cells in the early stages of cancer. Before screening a person, they spray that short protein attached to a fluorescent beacon into the colon. The protein then gloms on to any cancerous cells and creates an easily visible fluorescent patch. They then used a miniaturized microscope called Cellvizio GI, developed by Paris-based Mauna Kea Technologies and loaned to Contag, to peer inside the colon and look for those telltale spots.
Not only did the researchers see fluorescent patches, they could make out the individual cancerous cells. That fine resolution could allow doctors to pick up the earliest possible cancers. Contag said it could also become a useful research tool for studying the small number of cancer stem cells that are thought to establish the eventual tumor.
In the initial trial with 15 patients, the technique detected 82 percent of the polyps that were considered cancerous by a pathologist. Contag said the next step is to work with some of the additional small proteins they’ve found that also attach to cancerous cells. He thinks that a combination of those proteins will make the technique highly accurate.
Once the screen is ready for widespread use, Contag said it could bring accurate cancer detection to people in remote locations who otherwise don’t have access to pathology labs. “A doctor could send a video in real time via the Internet to someone trained to analyze the living cell images,” Contag said. This could help people begin the appropriate therapy when the cancer is still at an early stage.
Stanford press release: Cancer detected earlier, faster, with new medical imaging, Stanford study finds...
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Wednesday, February 20, 2008
FDA Rejects PillCam Colon
The FDA has sent Given Imaging, an Israeli company famous for its line of capsule endoscopes, a "not substantially equivalent" (NSE) letter regarding its 510(k) application to market PillCam(R) COLON in the US.
The company's president and CEO Homi Shamir is not happy:
"While we are disappointed by the FDA's decision we are evaluating our options to bring PillCam Colon to the US market as quickly as possible. We recently launched PillCam Colon in Europe and in other countries, and we are working closely with leading GI clinicians to determine its optimal role in patient care. On a parallel track and consistent with our commitment to innovation, we are accelerating development of a next generation colon capsule."
On a positive side, PillCam Colon has just been approved for marketing across the wide expanse of Israel.
More from Globes...
Flashback: PillCam Colon
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Friday, January 25, 2008
Single Optical Fiber Endoscope
A group under Dr. Eric Seibel, a University of Washington research associate professor of mechanical engineering, developed a single optical fiber endoscope that reportedly has all the advantages of capsule endoscopic technology, plus the ability to control the position and orientation that comes with a regular hand held device:
Most of today's endoscopes capture the image using a traditional approach where each part of the camera captures a different section of the image. These tools are long, flexible cords about 9 mm wide, about the width of a human fingernail. Because the cord is so wide patients must be sedated during the scan.The scanning endoscope developed at the UW is fundamentally different. It consists of just a single optical fiber for illumination and six fibers for collecting light, all encased in a pill. Seibel acted as the human volunteer in the first test of the UW device. He reports that it felt like swallowing a regular pill, and the tether, which is 1.4 mm wide, did not bother him.
Once swallowed, an electric current flowing through the UW endoscope causes the fiber to bounce back and forth so that its lone electronic eye sees the whole scene, one pixel at a time. At the same time the fiber spins and its tip projects red, green and blue laser light. The image processing then combines all this information to create a two-dimensional color picture.
In the tested model the fiber swings 5,000 times per second, creating 15 color pictures per second. The resolution is better than 100 microns, or more than 500 lines per inch. Although conventional endoscopes produce images at higher resolution, the tethered-capsule endoscope is designed specifically for low-cost screening.
Using the scanning device is cheap because it's so small it doesn't require anesthesia and sedation, which increase the cost of the traditional procedure.
"The procedure is so easy I could imagine it being done in a shopping mall," Seibel said.
A wireless scope manufactured by a different group, originally designed to pass through the body and detect intestinal cancer, is now being marketed for esophageal cancer screening. The competing technology comes in a pill about the width of an adult fingernail and twice as long. By contrast, the UW's scanning fiber endoscope's dimensions are about half as big and the device fits inside a standard pill capsule. The pill could be even smaller, Seibel said, but the researchers chose a size that would be easy to handle and swallow.
Another disadvantage of wireless capsules is they only allow a single fly-by view.
"You have no control over the other pill once it's swallowed. It just flutters down," Seibel said. But since the UW scope is tethered, the doctor can move it up and down along the region of interest.
Only a small percentage of people who get Barrett's esophagus, about 5 percent to 10 percent, develop cancer. So any screening method must have a low price to be cost-effective.
"The next big challenge is to make this cheaply," Seibel said. The researchers are negotiating a contract to commercialize the technology.
Project page: Engineering Study of an Endoscope Design ...
Press release: Camera in a pill offers cheaper, easier window on your insides ...
Flashbacks: Capsule Endoscope by Olympus ; PillCam ESO 2;PillCam Colon; PillCam
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Tuesday, November 20, 2007
Philips Electronic Drug Delivery Pill
Just to let you know, Philips has filed a patent application for an electronic drug delivery capsule with remote controlled medication release, and RFID technology for authentication and identification purposes.
The abstract of the patent application:
The pill includes a housing; a medicament reservoir for storing a medicament; an electronically controlled release valve or hatch for dispensing one or more medicaments stored in the medicament reservoir while traversing the gastrointestinal tract; control and timing circuitry for opening and closing the valve; and a battery. The control and timing circuitry opens and closes the valve throughout a dispensing time period in accordance with a preset dispensing timing pattern which is programmed within the control and timing circuitry. RF communication circuitry receives control signals for remotely overriding the preset dispensing timing pattern, reprogramming the control and timing circuitry, or terminating the dispensing of the medicament within the body. The pill includes an RFID tag for tracking, identification, inventory and other purposes.
Patent application: ELECTRONICALLY AND REMOTELY CONTROLLED PILL AND SYSTEM FOR DELIVERING AT LEAST ONE MEDICAMENT
(hat tip: Engadget and New Scientist)
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Tuesday, November 13, 2007
EndoCAD: A Real Time Upper GI Reference System
A new image-processing system from German developers is said to be able to assist gastroenterologists with making proper diagnoses, by referencing images on file to the appearance of upper GI tract during endoscopy.
Fraunhofer-Institut für Integrierte Schaltungen explains:
In order to detect these health-damaging changes, the physician performs an endoscopic examination of the esophagus. But the resulting images are not always easy to interpret. Is it a definite case of Barrett's ulcer, or is the esophagus healthy? Medical practitioners will soon be able to obtain help with their diagnosis. Researchers at the Fraunhofer Institute for Integrated Circuits IIS in Erlangen have developed a system named EndoCAD for this purpose. "The physician marks an area of tissue that appears to be abnormal, and EndoCAD compares it with a set of images stored in a database. The system selects the images showing the greatest similarity with respect to coloration and structural features," explains IIS project manager Dr. Christian Münzenmayer. "The selected images are displayed together with the corresponding, confirmed diagnosis. This gives the physician some useful points of reference for establishing a diagnosis." The system can be used similarly to analyze endoscopic images of the larynx as a starting point for a diagnosis."EndoCAD's performance is particularly good because it compares the marked sections of the images with respect to both structure and coloration. Our system has performed reliably using the clinical data that has been available up to now, with an overall classification rate of over 85 percent," says Münzenmayer. The research team will be demonstrating a prototype of the system at Medica 2007 in Düsseldorf from November 14 to 17 (Hall 10, Stand F05).
Press release: Diagnostic tool for esophageal cancer ...
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Wednesday, September 19, 2007
EndoCapsule Gets FDA Clearance
Olympus Medical Systems has received marketing clearance from the FDA for its EndoCapsule endoscope system, reports the Globes. We covered this endoscopic system in two previous posts: May '05 Capsule Endoscope by Olympus, and Oct '05 Olympus Launches High-resolution Endo Capsule System in Europe.
The EndoCapsule system is now the main competitor to a highly successful PillCam capsular endoscopy system from Israel's Given Imaging. Gil Shlomo of the Globes believes that in the short term, this development will deal a blow to Given's market domination, because of Olympus's strong marketing reach. In the long term, the outlook for both companies is good, since a large world-wide company like Olympus will expand the horizons of the capsule endoscopy market, and the technology will find greater acceptance among clinicians and patients alike.
What's also not clear is whether Given will follow up on its earlier warning to litigate Olympus for alleged infractions of its patents.
Globes: Given Imaging rival wins FDA approval ...
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Monday, August 27, 2007
Siemens' Colonography Gets an Update
Here are some details on a recently released version of computer-assisted CT colonography from Siemens:
The solution was developed using an extensive database of more than 1700 CT colonography cases from more than 15 clinical sites worldwide, and covers a variety of CT acquisition parameters and bowel preparation protocols. "Increased colorectal cancer screening is creating a demand for tools that improve speed, enhance confidence and offer our patients the highest possible level of care," said Dr. Anno Graser, Klinikum Grosshadern, Munich, Germany. "The PEV solution [PEV=Polyp Enhanced Viewing --ed.] from Siemens represents a valuable support mechanism for detecting polyps, especially in the important 5-9 mm size range which require a high level of sensitivity and are critical during early diagnosis."In addition to the PEV tool, Siemens recently introduced its auto-processing feature. Auto-Processing of CT data is Siemens latest in a portfolio of innovative solutions for improved workflow in CT. With its pre-processing technology for oncology, cardiac and acute care imaging, Siemens is helping radiologists to obtain critical images when and where needed in order to make faster and more efficient diagnostic decisions. In the field of oncology, data acquired on a Siemens Somatom CT scanner for colon exams is automatically processed off-line as it arrives at the syngo MultiModality Workplace. When the radiologist accesses the exam data using the syngo Colonography CT application, potential lesions are identified and ready for review when the reader accesses the PEV function.
Product page: syngo Colonography with PEV
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Thursday, August 9, 2007
Eat Away, Just Don't Digest
News 14 of North Carolina is reporting that the Carolinas Medical Center has implanted its first Endobarrier Gastrointestinal Liner as an experiment in treating morbid obesity, especially in type 2 diabetics. Similar in function to gastrointestinal bypass surgery, in that it limits digestion, the device is implanted non-invasively through the esophagus. Though information is almost non-existent about the device online, including who the manufacturer is, it is also being experimented with at Academisch Ziekenhuis Maastricht (Maastricth Academic Hospital, Holland).
From News 14:
"This is again performed endoscopically with a device that goes down the esophagus into the stomach where the device is deployed. The theory is food goes on the inside of this endobarrier. The digestive enzymes are on the outside of the endobarrier and the food and digestive enzymes don't mix until two feet further down stream in the smaller bowel."While it is similar to the gastric bypass, it's not a replacement for those who need the surgery just yet.
"For now, it's not instead of, it's prior too gastric bypass. Whether or not this becomes a procedure instead of gastric bypass remains to be seen," said Gersin.
At 2-3 months, the average weight loss is 20-30 pounds.
More from News 14 with Video of the EndoBarrier...
And in Dutch from Nieuws.nl...
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Wednesday, August 1, 2007
Early Detection of Pancreatic Cancer: A New Hope
A collaborative effort between a group of biomedical engineers and gastroenterologists at the Northwestern Medical School has resulted in what seems to be a potentially lifesaving test to detect early stages of pancreatic cancer. The newly developed technology relies on scanning a part of the duodenum around the Ampulla of Vater with an endoscope, and analyzing the returning light with low-coherence enhanced backscattering spectroscopy (LEBS).
The National Science Foundation explains:
Using novel light-scattering techniques, researchers have found the first evidence that early stage pancreatic cancer causes subtle changes in part of the small intestine. The easily monitored marker may ultimately allow early detection for a disease notorious for having few obvious symptoms, the primary reason pancreatic cancer killed more than 33,000 Americans last year.The new detection techniques, developed with support from the National Science Foundation (NSF), produce an optic fingerprint from the altered tissue and then enhance the data for a clearer diagnosis.
The researchers scanned tissue samples from 19 people already diagnosed with pancreatic cancer and 32 without the disease. They properly distinguished patients with cancer at an accuracy approaching 100 percent. The clearest results came from patients in the earliest stages of the disease...
The results build upon prior studies with colon cancer and support the "field effect" hypothesis that suggests initial cancer stages, even pre-cancerous lesions, can cause minute, potentially detectable changes throughout an entire organ. If similar results are found in other organs, the effect could have broad impact in the timely treatment of breast cancer, lung cancer and others.
The team of engineers from Northwestern University in Evanston, Ill., and physicians from Evanston-Northwestern Healthcare (ENH), reported the findings in the Aug. 1, 2007, Clinical Cancer Research.
"This novel technology uses light to probe tissue architecture at submicron scale. We are excited about this technology because it enables sensing subtle changes in tissue that otherwise are undetectable by conventional microscopic examination," said Northwestern engineer Vadim Backman, an NSF CAREER awardee who led the development of the new technologies and is a co-author on the research.
By studying tissue extracted from an area adjacent to the pancreas, the researchers were able to screen all 51 patients with little risk of inflammation or other complications.
While clinical use is perhaps three to five years in the future, and ongoing studies are needed to confirm the results, the researchers hope the tests can eventually be done without the biopsy.
Press release: Shining Light on Pancreatic Cancer ...
Video: At the cellular level, tissue from the duodenum is identical from a patient with ...
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Friday, July 6, 2007
CE Approved Allium Stents
Allium Group, a Caesarea, Israel start up, has obtained two CE Marks of approval from the European Union bureaucrats to market its biliary and ureteral stents, reports Globes [online].
The company believes its stent technology is far superior to others on the market:
Allium's thin-walled, large caliber, self-expanding, fully covered metal stents are unique because they can be left in the body for long periods without being changed and easily removed even after long implant periods. Allium's stents are cost effective and more acceptable to physicians and patients.The stents developed by Allium are designed to treat malignant as well as benign obstructions. They are engineered to prevent foreshortening during deployment allowing excellent accuracy in their placement and to prevent tissue ingrowth...
Allium's self-expanding Biliary Stent has a large caliber (8-10mm in diameter) and is made of a superelastic alloy covered by a polymeric material. The stent has a tubular shape to fit the common bile duct anatomy combined with a specially designed proprietary element on its ends to minimize reactive tissue proliferation.
The deployment procedure can be performed using the standard ERCP procedure or percutaneously.
Press release: Allium Group receives CE Marks for two of its next-generation urinary and gastrointestinal-tract stents ...
Globes [online]: Allium wins CE Mark for biliary and ureteral stents ...
Product pages: Allium's self-expanding Biliary Stent; Allium's Ureteral Stent.
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Thursday, July 5, 2007
Odor-Reader Wins University of Bristol's New Enterprise Competition
Any good nurse can diagnose a patient with C-Diff the moment they walk in the room, but now we have a machine to do it for us.
A pioneering new device that could help over four billion adults and children who suffer from infectious diarrhoea in the developing world and reduce outbreaks of diseases such as clostridium difficile (C.Diff) in UK hospital wards is the winner of this year's University of Bristol's New Enterprise Competition.Dr Chris Probert, Consultant and Reader in Gastroenterology at Bristol University and Professor Norman Ratcliffe at the University of the West of England, developed Odor-Reader, a device able to rapidly diagnose gastrointestinal disease by 'reading' the odour of biological fluids including stool and urine.
Delays in diagnosing gastrointestinal diseases can lead to patients being ill for longer, some may die, many will cost more to treat along with infections spreading to other people. In England and Wales there are over 50,000 cases of C.Diff (the latest 'superbug') each year. The infection prolongs hospitalisation and is associated with high morbidity and mortality as well as costing the NHS around £60 million annually.
The first prize of £15,000 was awarded to the researchers at the University's annual enterprise dinner held tonight.
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» Hydrogel Pill Expands in Your Stomach, Not in Your Hands (July 3, 2007)
» 560 Series HD Camera from Smith & Nephew (June 21, 2007)
» PillCam™ ESO 2 (June 14, 2007)
» GM Rice to Carry Cholera Vaccine (June 13, 2007)
» Video of The Aer-O-Scope™ (June 12, 2007)