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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 is a NA study that was terminated before completion, run by EndoGastric Solutions. The registered enrollment target is 112 participants.
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.
Interventions
- PROCEDURE Sham procedure
- DEVICE StomaphyX
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2009-07 |
| Est. Completion | 2012-06 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00939055
The ClinicalTrials.gov registry entry for NCT00939055 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EndoGastric Solutions, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Sham procedure is the first listed.
NCT00939055 reports 0 study locations.
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.
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