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NCT01378065 · ClinicalTrials.gov registry record
Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study
A clinical trial, sponsored by Coloplast A/S.
- Completed
- Registry status
- 31
- Enrollment target
NCT01378065: Completed study, sponsored by Coloplast A/S.
NCT01378065 is a clinical trial that has completed, run by Coloplast A/S. The registered enrollment target is 31 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01378065 has completed, sponsored by Coloplast A/S.
- COMPLETED
- Registry status
- 31 participants
- Enrollment target
Study Summary
This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A\&P mesh after vaginal reconstruction surgery.
Primary Outcome
Measured via palpability scale with possible outcomes of none, mild, moderate, or severe.
Interventions
- DEVICE Restorelle Direct Fix A&P
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-09 |
What the finished NCT01378065 record still lists
NCT01378065 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 31 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Restorelle Direct Fix A&P is the first listed.
NCT01378065 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01378065 about?
NCT01378065 is a clinical study titled "Restorelle Direct Fix Anterior and Posterior (A&P) for Female Pelvic Organ Prolapse: A Prospective Post Market Study". This is a prospective, multi-center study designed to assess the palpability of the Restorelle Direct Fix A\&P mesh after vaginal reconstruction surgery.
What is the current status of trial NCT01378065?
This trial is currently completed. The enrollment target is 31 participants. The study started on 2011-06. Estimated completion is 2013-09.
What interventions are being tested in trial NCT01378065?
The interventions under investigation include: Restorelle Direct Fix A&P (DEVICE).
Who is sponsoring clinical trial NCT01378065?
This trial is sponsored by Coloplast A/S, which has 21 total clinical trials registered on ClinicalTrials.gov.
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