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OpenTrials
Completed

NCT Number: NCT00411489

Endoscopic Stomach 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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lahey Clinic, Burlington, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

endolumenal surgery

Procedure

Primary outcomes

  1. weight loss

Sponsors and collaborators

Lead sponsor

USGI Medical

Industry

Registry information

Official study 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

Important dates

First posted
Dec 14, 2006
Registry last updated
Mar 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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