Transoral Gastroplasty for the Treatment of Morbid Obesity (TOGA®)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Satiety, Inc..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Satiety, Inc.
ClinicalTrials.gov Identifier:
NCT00661245
First received: April 15, 2008
Last updated: May 4, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Obesity
Device: TOGA
Device: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Satiety, Inc.:

Primary Outcome Measures:
  • Effectiveness: The proportion of subjects with ≥ 25% EWL (excess weight loss); Safety: Pre-defined objective performance criteria (OPC) [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Improvement in Co-morbidities; Improvements in other Obesity Measures and in Quality of Life Measures [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 275
Study Start Date: July 2008
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TOGA
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.
Device: TOGA
Transoral Gastroplasty (TOGA®) System for gastric stapling.
Sham Comparator: Control
A gastric sleeve is not formed.
Device: Control
The control device (bougie dilator) is a FDA-cleared (Class II) device.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-60
  2. BMI ≥ 40 kg/m2 and < 55 kg/m2, or BMI ≥ 35 kg/m2 with one or more significant co morbidities
  3. History of obesity for at least 2.5 years.
  4. History of stable weight (defined as a < 10% change in excess weight) for one year prior to the screening visit.
  5. History of failure with non-surgical weight loss methods.
  6. Suitable candidate for bariatric surgery based on the results of their psychological and physical evaluations.
  7. 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.
  8. Subject lives, and intends to remain, within a 100 mile radius of the study center for 5 years.

Exclusion Criteria:

  1. Hormonal or genetic cause for the obese state.
  2. History of cancer other than localized basal cell carcinoma.
  3. History of inflammatory disease of the gastrointestinal tract including Crohn's disease, ulcerative colitis, severe intractable esophagitis, gastric ulceration, or esophageal or duodenal ulceration.
  4. Active peptic ulcer disease.
  5. 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.
  6. Myocardial infarction or cerebrovascular accident within past year.
  7. Angina pectoris.
  8. Inability to extend neck or fully open mouth.
  9. Clinically severe cervical spinal disease, including cervical disc disease, vertebral osteophytes.
  10. Critically loose teeth.
  11. Temporomandibular joint syndrome (TMJ) or patients at risk for developing TMJ.
  12. Severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000)
  13. Gastroparesis
  14. Upper GI bleeding conditions such as esophageal or gastric varices, portal hypertensive gastropathy, congenital or acquired intestinal telangiectasis.
  15. Congenital or acquired anomalies of the GI tract such as atresias or stenoses.
  16. Structural abnormalities of the GI tract such as diverticulum.
  17. Lesions with increased risk of bleeding.
  18. Hiatal hernia ≥ 2cm.
  19. Severe cardiopulmonary disease or other serious organic disease, including HIV or cancer.
  20. Congestive heart failure.
  21. Uncontrolled hypertension (systolic >150 or diastolic > 100).
  22. Advanced rheumatoid arthritis.
  23. Severe or advanced liver disease (such as cirrhosis, chronic hepatitis, portal hypertension, etc.).
  24. Chronic pancreatitis.
  25. Any contraindication to endoscopy.
  26. Severe reflux disease.
  27. Currently pregnant or nursing.
  28. 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.
  29. Alcohol (> 80 gm/day of ethanol) or illicit drug use within the last 3 years.
  30. Prior gastric, esophageal, pancreatic or bariatric surgery.
  31. Currently on prescription or over the counter diet drugs.
  32. Chronic therapy with aspirin, NSAID or anticoagulants.
  33. Systemic infection at the time of the procedure.
  34. Patient with a known diagnosis or pre-existing symptoms of autoimmune connective tissue disease (i.e., systemic lupus erythematosus or scleroderma).
  35. Thyroid disease which is not controlled with medication
  36. Unacceptable medical risk (general health status would preclude surgery should a complication occur).
  37. Not ambulatory.
  38. Participating in another ongoing clinical trial in which concomitant diagnosis or therapeutic intervention would adversely affect the integrity of the clinical trial.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661245

Locations
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
Belgium
Hospital Erasme, Universite Libre de Bruxelles
Brussels, Belgium
Sponsors and Collaborators
Satiety, Inc.
  More Information

No publications provided

Responsible Party: Allan L. Abati, Ph.D., VP of RA, QA & Clinical Programs, Satiety, Inc.
ClinicalTrials.gov Identifier: NCT00661245     History of Changes
Other Study ID Numbers: S107
Study First Received: April 15, 2008
Last Updated: May 4, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 21, 2014