Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass (NCT00394212) | Clinical Trial Compass
TerminatedPhase 3
Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
Stopped: For business reasons
United States77 participantsStarted 2006-11
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.