Doctors at NewYork-Presbyterian Hospital/Columbia University Medical Center have initiated the first US clinical trial on the TOGA device, made by Satiety, Inc. out of Palo Alto, California, designed for transoral gastroplasty using an endoscopic approach.
In the new procedure, the surgeon introduces a set of flexible stapling devices through the mouth into the stomach, and uses them to create a restrictive pouch that is intended to catch food as it enters the stomach, giving patients a feeling of fullness after a small meal.
"The benefits of an endoscopic approach are less pain, quicker recovery, shortened hospital stay and decreased complications, as well as a lack of scarring," says study co-investigator Dr. Davis, a surgeon at NewYork-Presbyterian Hospital/Columbia University Medical Center and assistant professor of surgery at Columbia University College of Physicians and Surgeons. "Eventually, TOGA may also be an option for patients who are unable or unwilling to undergo more invasive surgery."
A 2006–2007 pilot study at medical centers in Mexico and Belgium found that patients receiving the TOGA procedure lost more than a third of their excess body weight. By 12 months, their excess weight loss averaged almost 40 percent.
In the current study, two out of three patients will receive the TOGA procedure, while one out of three will receive a control procedure, which is similar to the TOGA procedure except no pouch is created. After one year, patients will be told which procedure they received, and patients who received the control procedure will be offered the TOGA procedure if they continue to meet the treatment criteria.
Patients enrolled in the clinical trial will be followed for a minimum of 12 months. All study-related medical care will be provided at no charge to the patient, and patients will receive medically supervised nutritional counseling.
Video from Satiety, the manufacturer of TOGA:
TOGA product brochure (.pdf)…
Satiety, Inc. homepage…
NewYork-Presbyterian Hospital/Columbia University Medical Center press release: NYC Area’s First Patient Receives New Incision-Free Weight-Loss Surgery…