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

NCT ID: NCT00411489

Last Updated: 2008-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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endolumenal surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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USGI Medical

INDUSTRY

Sponsor Role lead

Principal Investigators

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Lee L Swanstrom, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Clinic

Locations

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Lahey Clinic

Burlington, Massachusetts, United States

Site Status

Mt. Sinai School of Medicine

New York, New York, United States

Site Status

Columbia-Presbyterian Medical Center

New York, New York, United States

Site Status

Oregon Clinic

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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TP0165

Identifier Type: -

Identifier Source: secondary_id

TP0165

Identifier Type: -

Identifier Source: org_study_id