Status:
COMPLETED
Endoscopic Stomach and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery
Lead Sponsor:
USGI Medical
Conditions:
Obesity
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
The Roux-En-Y gastric bypass procedure is the most commonly performed bariatric procedure in the United States. Despite initial weight loss, some patients experience weight regain that may be related ...
Eligibility Criteria
Inclusion
- 18 yrs of age or older and \< 65 yrs of age
- At least 2 yrs post-Roux-En-Y gastric bypass surgery
- Initially achieved at least 50% weight loss
- At enrollment, has regain at least 15% of weight loss
- BMI 40 or greater or 35 or greater with one or more co-morbidities
- Stoma diameter at least 20 mm
- Completes successful nutritional screening
- Is a candidate for a surgical revision procedure
- Is a reasonable risk to undergo general anesthesia
- Completes successful cardiopulmonary evaluation
- ASA Classification of less than or equal to III
- Able to provide written consent
- Able to return for protocol-specified evaluations
Exclusion
- Esophageal stricture or other anatomy/condition that precludes passage of endolumenal instruments
- Previous bariatric revision procedure
- Has another causal factor for weight regain other than stoma or pouch dilatation
- Non-mobile or has significant impairment of mobility that will limit compliance with post-op exercise program
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00411489
Last Update
March 18 2008
Active Locations (4)
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1
Lahey Clinic
Burlington, Massachusetts, United States, 01805
2
Mt. Sinai School of Medicine
New York, New York, United States, 10029-6574
3
Columbia-Presbyterian Medical Center
New York, New York, United States, 10032
4
Oregon Clinic
Portland, Oregon, United States, 97210