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Sponsored by: |
USGI Medical |
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Information provided by: | USGI Medical |
ClinicalTrials.gov Identifier: | NCT00411489 |
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 to an increase in the size of the gastric pouch and/or stoma. A second surgical procedure to reduce the size of the pouch and/or stoma is typically associated with a higher risk of death or complications than the original gastric bypass procedure.
This study will evaluate a less invasive, endolumenal alternative to pouch and stoma revision as a means of producing weight loss in patients who have regained weight following gastric bypass.
Condition | Intervention |
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Obesity |
Procedure: endolumenal surgery |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Uncontrolled, Single Group Assignment |
Official Title: | Use of a New Endosurgical Operating System for Endoscopic Stoma and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery |
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Lahey Clinic | |
Burlington, Massachusetts, United States, 01805 | |
United States, New York | |
Mt. Sinai School of Medicine | |
New York, New York, United States, 10029-6574 | |
Columbia-Presbyterian Medical Center | |
New York, New York, United States, 10032 | |
United States, Oregon | |
Oregon Clinic | |
Portland, Oregon, United States, 97210 |
Principal Investigator: | Lee L Swanstrom, MD | Oregon Clinic |
Study ID Numbers: | TP0165, TP0165 |
Study First Received: | December 12, 2006 |
Last Updated: | March 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00411489 History of Changes |
Health Authority: | United States: Institutional Review Board |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |
Body Weight Signs and Symptoms Obesity |
Nutrition Disorders Overweight Overnutrition |