Status:
TERMINATED
Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
Lead Sponsor:
C. R. Bard
Conditions:
Obesity
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost. One possibl...
Eligibility Criteria
Inclusion
- 6 months post primary RYGB with inadequate weight loss or weight regain
- BMI \>30 and ≤ 50
- Dilated gastrojejunal anastomosis
- Successfully completes screening process
- Signed consent
Exclusion
- Recently quit smoking or plan to quit within the next year
- Pregnant or planning to become pregnant over the course of the next 9 months
- Mallampati score of 4
- Serious systemic disease or active disease of the gastrointestinal tract
- Gastric pouch abnormalities
- Significant movement limitations
- Use of weight-promoting or weight-reduction drugs during study period
- Severe eating disorders
- Uncontrolled depression or psychoses
- Ongoing severe complication resulting from initial RYGB or other condition that in the investigators' assessment would make the patient an unsuitable candidate for the study procedure
- History of significant cardiovascular, cerebrovascular or pulmonary disease
- Not a candidate for conscious or general sedation
- Anticoagulant therapies
- Active substance abuse
- Life expectancy \< 1 year
- Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's study endpoints
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT00394212
Start Date
November 1 2006
End Date
May 1 2009
Last Update
September 21 2016
Active Locations (10)
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1
Denver, Colorado, United States
2
Baltimore, Maryland, United States
3
Boston, Massachusetts, United States
4
St Louis, Missouri, United States