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NCT00939055 · ClinicalTrials.gov registry record · NA
StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight
A NA study, sponsored by EndoGastric Solutions.
- Terminated
- Registry status
- NA
- Development phase
- 112
- Enrollment target
NCT00939055: Clinical Trial NA study, sponsored by EndoGastric Solutions.
NCT00939055 is a NA study that was terminated before completion, run by EndoGastric Solutions. The registered enrollment target is 112 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00939055, a NA study, was terminated before completion, sponsored by EndoGastric Solutions.
- TERMINATED
- Registry status
- NA
- Development phase
- 112 participants
- Enrollment target
Study Summary
The Roux-en-Y gastric bypass (RNYGB) is a weight loss surgery that involves the creation of a small gastric pouch and rearrangement of the small intestine. Although RNYGB has been demonstrated as an effective bariatric procedure, a significant number of patients experience weight regain that is often associated with distended gastric anatomy. Open and laparoscopic approaches for revision are associated with higher complication rates than de novo procedures. This study will evaluate the safety and effectiveness of a revisional incisionless natural orifice surgery of the gastric pouch and stoma in producing weight loss in post-RNYGB patients who have experienced weight regain.
Primary Outcome
A clinically significant reduction in pre-RNYGB excess weight, defined by ≥15% EBL and BMI \< 35.
Interventions
- PROCEDURE Sham procedure
- DEVICE StomaphyX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2009-07 |
| Est. Completion | 2012-06 |
| Phase | NA |
Why NCT00939055 stopped before completion
NCT00939055 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham procedure is the first listed.
NCT00939055 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00939055 about?
NCT00939055 is a clinical study titled "StomaphyX Versus Sham for Revisional Surgery in Post-Roux-en-Y Patients to Reduce Regained Weight". The Roux-en-Y gastric bypass (RNYGB) is a weight loss surgery that involves the creation of a small gastric pouch and rearrangement of the small intestine. Although RNYGB has been demonstrated as an effective bariatric procedure, a significant number of patients experience weight regain that is ofte...
What is the current status of trial NCT00939055?
This trial is currently terminated. It is a NA study. The enrollment target is 112 participants. The study started on 2009-07. Estimated completion is 2012-06.
What interventions are being tested in trial NCT00939055?
The interventions under investigation include: Sham procedure (PROCEDURE), StomaphyX (DEVICE).
Who is sponsoring clinical trial NCT00939055?
This trial is sponsored by EndoGastric Solutions, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00939055's enrollment target sits among peer trials
112 813th of 2000 higher than 1,185 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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