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

This study has been completed.

Sponsored by:	USGI Medical
Information provided by:	USGI Medical
ClinicalTrials.gov Identifier:	NCT00411489

Purpose

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
Obesity	Procedure: endolumenal surgery

MedlinePlus related topics: Endoscopy Obesity Weight Control

U.S. FDA Resources

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

Further study details as provided by USGI Medical:

Primary Outcome Measures:

weight loss

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00411489

Locations

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

Sponsors and Collaborators

USGI Medical

Investigators

Principal Investigator:

Lee L Swanstrom, MD

Oregon Clinic

More Information

Study ID Numbers:	TP0165, TP0165
Study First Received:	December 12, 2006
Last Updated:	March 17, 2008
ClinicalTrials.gov Identifier:	NCT00411489
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on January 16, 2009