Transoral Gastroplasty for the Treatment of Morbid Obesity
TOGA®
1 other identifier
interventional
275
2 countries
11
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 obesity
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 15, 2008
CompletedFirst Posted
Study publicly available on registry
April 18, 2008
CompletedStudy Start
First participant enrolled
July 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedMay 5, 2009
May 1, 2009
2.3 years
April 15, 2008
May 4, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Effectiveness: The proportion of subjects with ≥ 25% EWL (excess weight loss); Safety: Pre-defined objective performance criteria (OPC)
12 months
Secondary Outcomes (1)
Improvement in Co-morbidities; Improvements in other Obesity Measures and in Quality of Life Measures
12 months
Study Arms (2)
TOGA
EXPERIMENTALThe 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.
Control
SHAM COMPARATORA gastric sleeve is not formed.
Interventions
Eligibility Criteria
You may qualify if:
- Age 18-60
- BMI ≥ 40 kg/m2 and \< 55 kg/m2, or BMI ≥ 35 kg/m2 with one or more significant co morbidities
- History of obesity for at least 2.5 years.
- History of stable weight (defined as a \< 10% change in excess weight) for one year prior to the screening visit.
- History of failure with non-surgical weight loss methods.
- Suitable candidate for bariatric surgery based on the results of their psychological and physical evaluations.
- Understands risks of procedure, agrees to follow protocol requirements, including signing informed consent, returning for follow-up visits, completing all required testing, completing diet and behavior modification counseling, committing to prolonged lifestyle changes, and agrees to comply with the substantial dietary restrictions required by the procedure.
- Subject lives, and intends to remain, within a 100 mile radius of the study center for 5 years.
You may not qualify if:
- Hormonal or genetic cause for the obese state.
- History of cancer other than localized basal cell carcinoma.
- History of inflammatory disease of the gastrointestinal tract including Crohn's disease, ulcerative colitis, severe intractable esophagitis, gastric ulceration, or esophageal or duodenal ulceration.
- Active peptic ulcer disease.
- Significant known esophageal disease, including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, diffuse esophageal spasm, and symptoms of dysmotility.
- Myocardial infarction or cerebrovascular accident within past year.
- Angina pectoris.
- Inability to extend neck or fully open mouth.
- Clinically severe cervical spinal disease, including cervical disc disease, vertebral osteophytes.
- Critically loose teeth.
- Temporomandibular joint syndrome (TMJ) or patients at risk for developing TMJ.
- Severe coagulopathy (prothrombin time \> 3 seconds over control or platelet count \< 100,000)
- Gastroparesis
- Upper GI bleeding conditions such as esophageal or gastric varices, portal hypertensive gastropathy, congenital or acquired intestinal telangiectasis.
- Congenital or acquired anomalies of the GI tract such as atresias or stenoses.
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Satiety, Inc.lead
Study Sites (11)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California, San Francisco
San Francisco, California, 94110, United States
UMass Memorial Medical Center (University of Massachusetts)
Worcester, Massachusetts, 01655, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455, United States
University of Missouri Health Care
Columbia, Missouri, 65212, United States
Washington University in St. Louis - School of Medicine
St Louis, Missouri, 63110, United States
Columbia University Medical Center
New York, New York, 10032, United States
University Hospitals Geauga Medical Center
Chardon, Ohio, 44024, United States
University Hospitals Case Medical Center
Cleveland, Ohio, 44106, United States
University of Texas Medical School at Houston
Houston, Texas, 77056, United States
Hospital Erasme, Universite Libre de Bruxelles
Brussels, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 15, 2008
First Posted
April 18, 2008
Study Start
July 1, 2008
Primary Completion
October 1, 2010
Last Updated
May 5, 2009
Record last verified: 2009-05