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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00411489
Recruitment Status : Completed
First Posted : December 14, 2006
Last Update Posted : March 18, 2008
Information provided by:
USGI Medical

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 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 or disease Intervention/treatment Phase
Obesity Procedure: endolumenal surgery Not Applicable

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Primary Outcome Measures :
  1. weight loss

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00411489

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
Principal Investigator: Lee L Swanstrom, MD Oregon Clinic Identifier: NCT00411489     History of Changes
Other Study ID Numbers: TP0165
First Posted: December 14, 2006    Key Record Dates
Last Update Posted: March 18, 2008
Last Verified: June 2007