Incision Free Obesity Surgery Update

A clinical trial for Transoral Gastroplasty for the Treatment of Morbid Obesity (TOGA®) started April 15,2008. This study is ongoing, but not recruiting anymore participants.

The TOGA procedure is an incision-free treatment using a set of flexible staplers introduced into the mouth and esophagus to create a sleeve in the stomach (transoral formation of a gastric sleeve). The TOGA sleeve limits the amount of food that can be eaten and gives the patient a feeling of fullness after a small meal.

Primary Outcome Measures:
Participants had over 25% excess weight loss after 12 months.

Secondary Outcome Measures:
Improvement in Co-morbidities; Improvements in other Obesity Measures and in Quality of Life Measures after 12 months.

Final data collection date for primary outcome measure is expected by October 2010.

Researchers in Mexico and Belgium also successfully tested TOGA weight loss over the past year. TOGA patients stayed overnight in a hospital after the procedure, but doctors believe it will eventually be performed on an outpatient basis. Repoprts indicates up to 45% of excess weight loss.

The Toga System for transoral gastroplasty is being developed by Satiety, Inc., a medical device company based in Palo Alto, Calif. The system comprises a set of flexible devices designed to be inserted through the mouth into the stomach to staple the stomach. The company is now conducting clinical trials with the hope of filing for FDA approval in the future.

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