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Status:

UNKNOWN

Transoral Gastroplasty for the Treatment of Morbid Obesity

Lead Sponsor:

Satiety, Inc.

Conditions:

Obesity

Eligibility:

All Genders

18-60 years

Phase:

PHASE3

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 wi...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

  • 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.
  • Severe reflux disease.
  • Currently pregnant or nursing.
  • Potentially childbearing (i.e. not post-menopausal or surgically sterilized) and not willing to use an effective method of contraception for the next 24 months.
  • Alcohol (\> 80 gm/day of ethanol) or illicit drug use within the last 3 years.
  • Prior gastric, esophageal, pancreatic or bariatric surgery.
  • Currently on prescription or over the counter diet drugs.
  • Chronic therapy with aspirin, NSAID or anticoagulants.
  • Systemic infection at the time of the procedure.
  • Patient with a known diagnosis or pre-existing symptoms of autoimmune connective tissue disease (i.e., systemic lupus erythematosus or scleroderma).
  • Thyroid disease which is not controlled with medication
  • Unacceptable medical risk (general health status would preclude surgery should a complication occur).
  • Not ambulatory.
  • Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.

Key Trial Info

Start Date :

July 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

Estimated Enrollment :

275 Patients enrolled

Trial Details

Trial ID

NCT00661245

Start Date

July 1 2008

Last Update

May 5 2009

Active Locations (11)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 3 (11 locations)

1

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

2

University of California, San Francisco

San Francisco, California, United States, 94110

3

UMass Memorial Medical Center (University of Massachusetts)

Worcester, Massachusetts, United States, 01655

4

University of Minnesota Medical Center

Minneapolis, Minnesota, United States, 55455