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UMass Memorial Begins Clinical Study of Incision-free Obesity Treatment

Date: May 27, 2009
Contact: Public Affairs and Publications 508-856-2000

WORCESTER - Doctors at UMass Memorial Medical Center are the first in New England to perform the investigational transoral gastroplasty (TOGA) procedure, an incision-free alternative to traditional surgery for treatment of morbid obesity. Using an endoscope to guide specialized instruments into a patient's stomach through the esophagus, surgeons can achieve the same goal - reduction of the size of the stomach pouch - for patients who may not choose conventional bariatric surgery. Performed as part of a pivotal multi-center clinical trial to evaluate the safety and effectiveness of the surgery, the noninvasive TOGA procedure may potentially be another treatment option for the approximately 15 million Americans suffering with morbid obesity.

"If the results from the clinical study are positive, the TOGA procedure may become an alternative for people who need to lose weight for health reasons but may have been hesitant to undergo current surgical options," said Kanishka Bhattacharya, MD, associate director of endoscopy at UMass Memorial Medical Center, assistant professor of medicine at UMass Medical School and principal investigator of the study.

In the TOGA procedure, a physician introduces a set of flexible stapling devices through the patient's mouth and into the stomach. Using specialized instruments, surgeons manipulate the stomach and create a thumb-sized pouch which, once created, is intended to catch food as it enters the stomach, giving patients a feeling of fullness after a small meal.

However, because the TOGA procedure does not require incisions like open or laparoscopic bariatric techniques, it is less invasive for the patient. As a result, the recovery time for the procedure is potentially shorter and less painful and complications are fewer.

John Kelly, MD, chief of general surgery and codirector of bariatric surgery at UMass Memorial Medical Center, associate professor of surgery at University of Massachusetts Medical School and co-investigator of the study, said that for many people the up to six-week recovery period required with conventional surgery can be cumbersome and impractical. "For those patients, the TOGA procedure may be a viable alternative because the disruption to their lives is potentially far less," he said.

According to the Centers for Disease Control and Prevention, as many as 7 percent of adults in America are morbidly obese. The body mass index - a type of weight/height ratio - for an overweight person begins at 25. Those who are morbidly obese have a BMI of at least 40. Additionally, a number of health problems, such as heart disease and diabetes, are associated with obesity.

"For those who are trying to lose weight, the TOGA technique represents another tool for them to achieve their goals," said Dr. Kelly. "Coupled with proper diet and exercise, patients can experience measureable and lasting weight loss that can have significant health benefits."

Data from a pilot study being conducted in Belgium, Mexico and Italy showed that participants in the study weighed an average of almost 120 pounds over their ideal body weight. Six months after the procedure, subjects had lost more than a third of their excess body weight. By 12 months, their excess weight loss averaged almost 40 percent.

The TOGA Pivotal Trial is being conducted at UMass Memorial Medical Center by a group of five surgeons and gastroenterologists including Dr. Kelly, Dr. Bhattacharya, David Cave, MD, professor of medicine, Richard Perugini, MD, assistant professor of surgery and Jaroslav Zivny, MD, assistant professor of medicine. The pivotal trial will help evaluate the safety and effectiveness of this new procedure for the treatment of morbid obesity. In the 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 a 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. The study is being conducted in nine medical centers in the county.

The TOGA System is an investigational device and does not currently have marketing approval by the U.S. Food and Drug Administration.

The Weight Center at UMass Memorial Medical Center helps adults struggling with obesity and weight-related disease develop strategies for significant weight loss. With the help of physicians and nutrition specialists and using behavioral medicine and exercise, patients craft a plan for healthy, long-lasting weight loss. All patients are evaluated by a behavioral medicine provider and medical director. Based on these evaluations, and through input from a registered dietician, a weight loss plan is created for each patient. Since 2000, the UMass Memorial Medical Center has performed approximately 2,000 laparoscopic gastric bypasses and 400 gastric banding procedures.