Transoral Gastroplasty for the Treatment of Morbid Obesity (TOGA®)
The TOGA® trial is a prospective, multi-center, randomized sham-controlled trial designed to determine the safety and effectiveness of the TOGA System for the treatment of morbid obesity. The study will also determine the effect of the treatment on co-morbidities and quality of life.
Subjects will be blinded to treatment or sham. Sham arm may crossover to TOGA treatment at 12 months.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
- Effectiveness: The proportion of subjects with ≥ 25% EWL (excess weight loss); Safety: Pre-defined objective performance criteria (OPC) [ Time Frame: 12 months ]
- Improvement in Co-morbidities; Improvements in other Obesity Measures and in Quality of Life Measures [ Time Frame: 12 months ]
|Study Start Date:||July 2008|
|Estimated Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
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.
Transoral Gastroplasty (TOGA®) System for gastric stapling.
Sham Comparator: Control
A gastric sleeve is not formed.
The control device (bougie dilator) is a FDA-cleared (Class II) device.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00661245
|United States, California|
|Cedars-Sinai Medical Center|
|Los Angeles, California, United States, 90048|
|University of California, San Francisco|
|San Francisco, California, United States, 94110|
|United States, Massachusetts|
|UMass Memorial Medical Center (University of Massachusetts)|
|Worcester, Massachusetts, United States, 01655|
|United States, Minnesota|
|University of Minnesota Medical Center|
|Minneapolis, Minnesota, United States, 55455|
|United States, Missouri|
|University of Missouri Health Care|
|Columbia, Missouri, United States, 65212|
|Washington University in St. Louis - School of Medicine|
|St. Louis, Missouri, United States, 63110|
|United States, New York|
|Columbia University Medical Center|
|New York, New York, United States, 10032|
|United States, Ohio|
|University Hospitals Geauga Medical Center|
|Chardon, Ohio, United States, 44024|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|United States, Texas|
|University of Texas Medical School at Houston|
|Houston, Texas, United States, 77056|
|Hospital Erasme, Universite Libre de Bruxelles|