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...

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)

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

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...

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...

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

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...

Product brochure (.pdf)...

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...

Mauna Kea Technologies...

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

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