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NCT00394212 · ClinicalTrials.gov registry record · Phase 3
Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass
A Phase 3 study, sponsored by C. R. Bard.
- Terminated
- Registry status
- Phase 3
- Development phase
- 77
- Enrollment target
NCT00394212 is a Phase 3 study that was terminated before completion, run by C. R. Bard. The registered enrollment target is 77 participants.
The verdict
NCT00394212, a Phase 3 study, was terminated before completion, sponsored by C. R. Bard.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 77 participants
- Enrollment target
Study 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.
Interventions
- DEVICE Transoral Suturing
- OTHER Sham Endoscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2006-11 |
| Est. Completion | 2009-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00394212
The ClinicalTrials.gov registry entry for NCT00394212 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 77 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is C. R. Bard, which has 75 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Transoral Suturing is the first listed.
NCT00394212 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00394212 about?
NCT00394212 is a clinical study titled "Incisionless Treatment for Patients With Inadequate Weight Loss Following Roux-en-Y Gastric Bypass". 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 ...
What is the current status of trial NCT00394212?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2006-11. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00394212?
The interventions under investigation include: Transoral Suturing (DEVICE), Sham Endoscopy (OTHER).
Who is sponsoring clinical trial NCT00394212?
This trial is sponsored by C. R. Bard, which has 75 total clinical trials registered on ClinicalTrials.gov.
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