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NCT03549780 · ClinicalTrials.gov registry record · NA
Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy
A NA study of Ileostomy - Stoma, sponsored by William A. Faubion, M.D..
- Completed
- Registry status
- NA
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT03549780: Completed NA study of Ileostomy - Stoma, sponsored by William A. Faubion, M.D..
NCT03549780 is a NA study of Ileostomy - Stoma that has completed, run by William A. Faubion, M.D.. The registered enrollment target is 8 participants, below the 123-participant average among 3 other Ileostomy - Stoma trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03549780, a NA study of Ileostomy - Stoma, has completed, sponsored by William A. Faubion, M.D..
- COMPLETED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
This investigation constitutes an initial evaluation of the stoma occlusion device in humans with a mature permanent Brooke ileostomy. The overall objective of this study is to assess feasibility and initial operating characteristics of a novel stoma occlusion device. The study will recruit 20 patients for placement of the device into the mature Brooke ileostomy and subsequent 2 hour observation period. The device will remain in the ileostomy for up to 2 hours.
Primary Outcome
Safety: Device is able to be inserted adequately (function) and without any significant patient discomfort or adverse events (safety).
Conditions Studied
Interventions
- DEVICE Stomal Occlusion Device
Study Locations (1)
Minnesota
- Mayo Clinic in Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2019-08-02 |
| Est. Completion | 2024-12-03 |
| Phase | NA |
What the finished NCT03549780 record still lists
NCT03549780 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 123-participant average among 3 other Ileostomy - Stoma trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Ileostomy - Stoma appearing as the primary indexed condition, and to 1 intervention - of which Stomal Occlusion Device is the first listed.
NCT03549780 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT03549780 about?
NCT03549780 is a clinical study titled "Novel Stomal Occlusion Device in Patients With a Brooke Ileostomy". This investigation constitutes an initial evaluation of the stoma occlusion device in humans with a mature permanent Brooke ileostomy. The overall objective of this study is to assess feasibility and initial operating characteristics of a novel stoma occlusion device. The study will recruit 20 patie...
What is the current status of trial NCT03549780?
This trial is currently completed. It is a NA study. The enrollment target is 8 participants. The study started on 2019-08-02. Estimated completion is 2024-12-03.
What conditions does trial NCT03549780 study?
This clinical trial studies the following conditions: Ileostomy - Stoma.
What interventions are being tested in trial NCT03549780?
The interventions under investigation include: Stomal Occlusion Device (DEVICE).
Who is sponsoring clinical trial NCT03549780?
This trial is sponsored by William A. Faubion, M.D., which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03549780 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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