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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00411489
• Other study ID #: TP0165
• Secondary ID: TP0165
• Status: Completed
• Phase: N/A
• First received: December 12, 2006
• Last updated: March 17, 2008

Study information

• Verified date: June 2007
• Source: USGI Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• endolumenal surgery

Locations

Country	Name	City	State
United States	Lahey Clinic	Burlington	Massachusetts
United States	Columbia-Presbyterian Medical Center	New York	New York
United States	Mt. Sinai School of Medicine	New York	New York
United States	Oregon Clinic	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
USGI Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss