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COMPLETEDNANCT00411489

Endoscopic Stomach and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery

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 ...

Lead sponsor: USGI Medical•4 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

USGI Medical

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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 Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 18, 2008Terms

Trial snapshot

StatusCOMPLETED

PhaseNA

Enrollment—

Start date—

Last updatedMar 18, 2008

Condition

Locations shown

Lahey Clinic

Burlington, Massachusetts

Mt. Sinai School of Medicine

New York, New York

Columbia-Presbyterian Medical Center

New York, New York

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2008Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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