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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-11-30

Study Completion Date

2009-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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1

Transoral suturing of the dilated gastrojejunostomy

Group Type EXPERIMENTAL

Transoral Suturing

Intervention Type DEVICE

suturing of anastomosis

2

Sham Endoscopy (suturing not performed)

Group Type SHAM_COMPARATOR

Sham Endoscopy

Intervention Type OTHER

suturing not performed

Interventions

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Transoral Suturing

suturing of anastomosis

Intervention Type DEVICE

Sham Endoscopy

suturing not performed

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No