TOGA U.S. Clinical Trial
Satiety, Inc. is currently conducting a multi-center U.S. pivotal study for the purpose of gaining U.S. Food and Drug Administration approval of the TOGA® System. The TOGA System is a set of flexible devices designed to be inserted through the mouth into the stomach to staple the stomach, limiting its capacity and giving patients a feeling of fullness after a small meal. Since the procedure is performed through the mouth and esophagus, there are no surgical incisions.
Title of Study: Pivotal Clinical Study – TOGA: A Randomized, Sham-Controlled Trial to Assess the Safety and Effectiveness of Transoral Gastroplasty in the Treatment of Morbid Obesity
The purpose of the U.S. pivotal study is to evaluate:
- Effectiveness of the TOGA® Procedure (weight loss)
- Safety of the TOGA Procedure
- Effect on obesity related illnesses
- Effect on quality of life measures
- Changes in medication use
Steps of the TOGA Procedure
With the patient under general anesthesia, the TOGA Sleeve Stapler is inserted through the mouth into the stomach
The stomach tissue is spread and positioned using a retraction device
(endoscopic view) Applying suction, tissue from the anterior and posterior of the stomach is collected into the device
(endoscopic view) the device is closed, and titanium staples are delivered
This creates a sleeve at the entry of the stomach, along the lesser curve
The TOGA Restrictor is inserted, and is used to narrow the bottom of the sleeve
The resulting pouch is designed to collect food as it enters the stomach, giving patients a feeling of fullness after a small meal.
Enrollment
Enrollment has been completed for this study.
Summary of the Pivotal Study on www.clinicaltrials.gov: http://www.clinicaltrials.gov/ct2/show/NCT00661245
CAUTION – The TOGA System is an investigational device, limited by United States law to investigational use.
