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NCT01080326 · ClinicalTrials.gov registry record · NA
Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus
A NA study of Peptic Ulcer, sponsored by Mayo Clinic.
- Completed
- Registry status
- NA
- Development phase
- 7
- Enrollment target
- 1
- Study location
NCT01080326: Completed NA study of Peptic Ulcer, sponsored by Mayo Clinic.
NCT01080326 is a NA study of Peptic Ulcer that has completed, run by Mayo Clinic. The registered enrollment target is 7 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01080326, a NA study of Peptic Ulcer, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is being done to see if a new approach to repair perforated ulcers in the stomach (holes in the stomach) or the first part of the intestine is possible. Traditionally, either open operations (large single incision) or laparoscopic operations (multiple small camera-guided incisions) have been used to repair perforated ulcers. Over the last ten years, some surgeons have used endoscopic equipment to assist them with performing the procedure. It is unknown if perforated ulcer repair can be done using an endoscope as the main instrument (a flexible tube with a video camera inserted into the stomach through your esophagus) to "patch" or plug the perforation. We will patch the perforation using a standard method which uses tissue from outside the stomach. A laparoscopic camera will also be used to assist our view. This study is intended to be a feasibility study to demonstrate the endoscopic technique can be safely performed Hypothesis: The primary outcome is successful completion of the procedure.
Primary Outcome
At the time of surgery the repair was pressure tested using endoscopic insufflation. Two days post-operation all participants receiving the NOTES repair underwent a water-soluble contrast study to demonstrate leakage. Note: The NOTES procedure was attempted first if the subject had no contraindication. If this proved unsuccessful the surgical team proceeded with conversion to laparoscopic or open standard surgical therapy as indicated.
Conditions Studied
Interventions
- DEVICE Endoscopic Translumenal Omental Patch
Study Locations (1)
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2010-03 |
| Est. Completion | 2012-12 |
| Phase | NA |
What the finished NCT01080326 record still lists
NCT01080326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Peptic Ulcer appearing as the primary indexed condition, and to 1 intervention - of which Endoscopic Translumenal Omental Patch is the first listed.
NCT01080326 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01080326 about?
NCT01080326 is a clinical study titled "Feasibility of Translumenal Endoscopic Omental Patch Closure of Perforated Viscus". This study is being done to see if a new approach to repair perforated ulcers in the stomach (holes in the stomach) or the first part of the intestine is possible. Traditionally, either open operations (large single incision) or laparoscopic operations (multiple small camera-guided incisions) have b...
What is the current status of trial NCT01080326?
This trial is currently completed. It is a NA study. The enrollment target is 7 participants. The study started on 2010-03. Estimated completion is 2012-12.
What conditions does trial NCT01080326 study?
This clinical trial studies the following conditions: Peptic Ulcer.
What interventions are being tested in trial NCT01080326?
The interventions under investigation include: Endoscopic Translumenal Omental Patch (DEVICE).
Who is sponsoring clinical trial NCT01080326?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01080326 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01080326's enrollment target sits among peer trials
7 1982nd of 2000 higher than 18 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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