Transoral Gastroplasty for the Treatment of Morbid Obesity

Status unconfirmed · Phase 3

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT00661245

Run by

Satiety, Inc.

People needed

275

Starts

2008-07-01

Last updated by the study team

2009-05-05

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

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.
• Structural abnormalities of the GI tract such as diverticulum.
• Lesions with increased risk of bleeding.
• Hiatal hernia ≥ 2cm.
• Severe cardiopulmonary disease or other serious organic disease, including HIV or cancer.
• Congestive heart failure.
• Uncontrolled hypertension (systolic >150 or diastolic > 100).
• Advanced rheumatoid arthritis.
• Severe or advanced liver disease (such as cirrhosis, chronic hepatitis, portal hypertension, etc.).
• Chronic pancreatitis.
• Any contraindication to endoscopy.

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• UMass Memorial Medical Center (University of Massachusetts) — Worcester, Massachusetts, United States
• University of Minnesota Medical Center — Minneapolis, Minnesota, United States
• University of Missouri Health Care — Columbia, Missouri, United States
• Washington University in St. Louis - School of Medicine — St Louis, Missouri, United States
• Columbia University Medical Center — New York, New York, United States
• University Hospitals Geauga Medical Center — Chardon, Ohio, United States
• University Hospitals Case Medical Center — Cleveland, Ohio, United States
• University of Texas Medical School at Houston — Houston, Texas, United States
• Hospital Erasme, Universite Libre de Bruxelles — Brussels, Belgium

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.