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

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ClinicalTrials.gov Identifier: NCT00661245
Recruitment Status : Unknown
Verified May 2009 by Satiety, Inc..
Recruitment status was:  Active, not recruiting
First Posted : April 18, 2008
Last Update Posted : May 5, 2009
Sponsor:
Information provided by:
Satiety, Inc.

Tracking Information
First Submitted Date  ICMJE April 15, 2008
First Posted Date  ICMJE April 18, 2008
Last Update Posted Date May 5, 2009
Study Start Date  ICMJE July 2008
Estimated Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 15, 2008)
Effectiveness: The proportion of subjects with ≥ 25% EWL (excess weight loss); Safety: Pre-defined objective performance criteria (OPC) [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2008)
Improvement in Co-morbidities; Improvements in other Obesity Measures and in Quality of Life Measures [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transoral Gastroplasty for the Treatment of Morbid Obesity
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Obesity
Intervention  ICMJE
  • Device: TOGA
    Transoral Gastroplasty (TOGA®) System for gastric stapling.
  • Device: Control
    The control device (bougie dilator) is a FDA-cleared (Class II) device.
Study Arms  ICMJE
  • 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.
    Intervention: Device: TOGA
  • Sham Comparator: Control
    A gastric sleeve is not formed.
    Intervention: Device: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 22, 2008)
275
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2008)
305
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00661245
Other Study ID Numbers  ICMJE S107
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allan L. Abati, Ph.D., VP of RA, QA & Clinical Programs, Satiety, Inc.
Study Sponsor  ICMJE Satiety, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Satiety, Inc.
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP