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

March 17, 2008 updated by: USGI Medical

Use of a New Endosurgical Operating System for Endoscopic Stoma and Pouch Reduction in Patients With Weight Regain Following Roux-En-Y Bypass Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic
    • New York
      • New York, New York, United States, 10032
        • Columbia-Presbyterian Medical Center
      • New York, New York, United States, 10029-6574
        • Mt. Sinai School of Medicine
    • Oregon
      • Portland, Oregon, United States, 97210
        • Oregon Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
weight loss

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USGI Medical

Investigators

  • Principal Investigator: Lee L Swanstrom, MD, Oregon Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

December 12, 2006

First Submitted That Met QC Criteria

December 12, 2006

First Posted (Estimate)

December 14, 2006

Study Record Updates

Last Update Posted (Estimate)

March 18, 2008

Last Update Submitted That Met QC Criteria

March 17, 2008

Last Verified

June 1, 2007

More Information

Terms related to this study

Other Study ID Numbers

  • TP0165

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on endolumenal surgery

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe