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

This study has been completed.
Sponsor:
Information provided by:
USGI Medical
ClinicalTrials.gov Identifier:
NCT00411489
First received: December 12, 2006
Last updated: March 17, 2008
Last verified: June 2007
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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 NLM:

U.S. FDA Resources

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

No publications provided

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

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on June 17, 2013