UCSF begins clinical trial of incision-free obesity treatment

By Kirsten Michener

A team of specialists at UCSF Medical Center has treated its first patients as part of a multi-center clinical study to evaluate an incision-free procedure for the treatment of obesity.

Like other obesity procedures, this investigational treatment is designed to modify stomach anatomy to give the patient a feeling of fullness after a small meal, therefore decreasing calorie intake.

The new treatment differs from standard procedures, such as the gastric bypass, because it is performed through the mouth, without incisions. In gastric bypass, which is surgical stomach stapling to treat obesity, incisions are made in the abdominal wall, a surgical approach that has been used for over 30 years. This new incision-free technique represents the next generation of bariatric surgery, according to the UCSF team.

The medical name for the investigational procedure is transoral gastroplasty, which is known informally as TOGA. The surgeon introduces a set of flexible stapling devices through the mouth into the stomach and, with endoscopic imaging, uses the devices to create a restrictive pouch. The pouch is intended to retain food as it enters the stomach, giving patients a feeling of fullness and reducing caloric intake.

The TOGA trial is being conducted to evaluate the safety and effectiveness of the new procedure for treating morbid obesity. In the study, two out of three patients will receive the TOGA procedure. One out of three will receive a control procedure that is similar to the TOGA procedure, except no pouch is created. After one year, patients will learn 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.

Stanley Rogers, MD, FACS, associate clinical professor of surgery and co-director of the UCSF Bariatric Surgery Center, and John Cello, MD, professor of medicine and surgery and a member of the gastroenterology division, are principal investigators of the UCSF clinical trial.  In late January, they headed a multidisciplinary team that performed the first two of 30 procedures currently scheduled at UCSF Medical Center.  UCSF is one of nine TOGA trial sites in the U.S., and there is one site in Belgium.

“Current results from studies performed in humans show weight loss outcomes similar to that achieved with the more invasive surgical procedures, including gastric banding,” said Rogers. The TOGA procedure typically takes just over an hour to perform, he said, and the short procedure time means patients are under anesthesia for less time than during the standard gastroplasty surgery. This, in addition to the absence of abdominal wall incisions, will allow the TOGA procedure ultimately to be performed on an outpatient basis, he added.  This contrasts with laparoscopic procedures, which involve an incision in the abdominal wall and a hospital stay of usually 24 to 48 hours.

UCSF is currently recruiting patients for its TOGA clinical trial.  Patients 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. UCSF is hoping to recruit 28 additional trial participants.

“Only through randomized controlled clinical trials such as this one at UCSF can we hope to demonstrate the clinical usefulness of TOGA,” said Cello. “We are optimistic that such a minimally invasive procedure can improve on the morbidity and mortality of obesity.”

Individuals who are between 18 and 60 years of age, are 100 or more pounds overweight, and have been unsuccessful with non-surgical weight loss methods are potential study participants. More information is available toll free by calling 1-866-678-8399 and at www.togaclinicalstudy.com.

The TOGA procedure involves an investigational device that does not have marketing approval by the U.S. Food and Drug Administration.

The clinical trial is being funded by Satiety, Inc., the manufacturer of the device.UCSF principal investigators Rogers and Cello do not serve in any compensated advisory, board of directors, or consultancy role with the company.

UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.  For further information, visit www.ucsf.edu.