The first patient in the New York City area received incision-free surgery for obesity as part of the ongoing multicenter TOGA Pivotal Trial at New York-Presbyterian Hospital/Columbia University Medical School. The trial is being sponsored by a start-up called Fatidy, maker of the endoscope used in the trial, a New York-Presbyterian spokeswoman told DOTmed News.

Drs. Marc Bessler and Daniel Davis performed the TOGA Procedure (for "transoral gastroplasty), which like other obesity procedures, is designed to alter the patients' stomach anatomy to give them a feeling of fullness after a small meal.

The difference is that TOGA was performed under direct endoscope visualization with specialized instruments passed into the stomach through the mouth without any incisions.

"This new surgery is an exciting option for severely overweight patients who do not respond to diet, exercise and drug therapy. We hope to show that, like other weight-loss operations, The TOGA procedure will help them to lose weight and improve their health, says Dr. Bessler, principal investigator and director of laparoscopic surgery and director of the Center for Obesity Surgery at New York-Presbyterian/Columbia. He is also an assistant professor of surgery at Columbia University College of Physicians and Surgeons.

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 stays and decreased complications, as well as a lack of scarring, says Dr. Davis, a surgeon at New York-Presbyterian Hospital/Columbia University Medical Center and assistant professor of surgery at Columbia.

"Eventually," Dr. Davis says, "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 TOGA but 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 treatment criteria.

Patients enrolled in the clinical trial will be followed for a minimum of 12 months. All medical care will be provided by Fatidy and patients will receive medically supervised nutritional counseling, as well.

Investigators will also evaluate weight loss and changes in obesity-related health problems such as Type 2 diabetes, cholesterol levels and hypertension. If successful, it is hoped that the study will result in FDA clearance of the TOGA System.

New York-Presbyterian/Columbia plans to enroll at least 15 patients out of a total 275 patients to be enrolled at centers nationwide. Volunteers must be 18 to 60 years old, more than 100 pounds overweight and must have been unsuccessful with non-surgical weight-loss methods.

For more information, prospective patients may call this toll-free number 866-678-8399 or visit www.togaclinical study.com.

Obesity is a global disease affecting more than 300 million people, according to the World health Organization. Obesity causes or contributes to numerous serious medical conductions, including Type 2 diabetes, hypertension, cardiovascular disease, arthritis, sleep apnea and certain types of cancer.

For an eye-opening animation of obesity incidence in the U.S., go to:
http://www.cdc.gov/nccdphp/dnpa/obesity/trend/maps/