Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Obesity

In brief

It is estimated that up to 20% of patients who have Roux-en-Y Gastric Bypass (RYGB) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost. One possible explanation is that the opening between the stomach pouch and the intestine becomes stretched. If this opening becomes too wide, food may be able to pass from the stomach to the intestine too quickly - causing patients to feel less full after eating. For some patients, doctors may recommend additional invasive surgery to tighten the opening between the stomach pouch and the small intestine. Although this may help patients resume their weight loss, the risk of complications during a second surgical procedure is significantly higher than the risk during the original gastric bypass. The purpose of this study is to evaluate an incisionless procedure for patients who have either had inadequate weight loss or have regained weight following gastric bypass. The procedure is designed to tighten the opening between the stomach pouch and the small intestine, which may slow down the passage of food to help patients feel full longer after eating.

Key facts

Study ID

NCT00394212

Run by

C. R. Bard

People needed

77

Starts

2006-11-01

Expected to finish

2009-05-01

Last updated by the study team

2016-09-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 6 months post primary RYGB with inadequate weight loss or weight regain
• BMI >30 and ≤ 50
• Dilated gastrojejunal anastomosis
• Successfully completes screening process
• Signed consent

You may not qualify if…

• Recently quit smoking or plan to quit within the next year
• Pregnant or planning to become pregnant over the course of the next 9 months
• Mallampati score of 4
• Serious systemic disease or active disease of the gastrointestinal tract
• Gastric pouch abnormalities
• Significant movement limitations
• Use of weight-promoting or weight-reduction drugs during study period
• Severe eating disorders
• Uncontrolled depression or psychoses
• Ongoing severe complication resulting from initial RYGB or other condition that in the investigators' assessment would make the patient an unsuitable candidate for the study procedure
• History of significant cardiovascular, cerebrovascular or pulmonary disease
• Not a candidate for conscious or general sedation
• Anticoagulant therapies
• Active substance abuse
• Life expectancy < 1 year
• Enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's study endpoints

Where it is running

• Study site — Denver, Colorado, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — St Louis, Missouri, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — New York, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Dallas, Texas, United States
• Study site — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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