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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: Clinical Trial Phase 3 study, sponsored by C. R. Bard.
NCT00394212 is a Phase 3 study that was terminated before completion, run by C. R. Bard. The registered enrollment target is 77 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percent Weight Loss is computed as \[(Baseline weight - 6 mo. weight) / Baseline weight\] \* 100
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 |
Why NCT00394212 stopped before completion
NCT00394212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Transoral Suturing is the first listed.
NCT00394212 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00394212's enrollment target sits among peer trials
77 1771st of 2000 higher than 228 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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