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NCT02162615 · ClinicalTrials.gov registry record
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
A clinical trial, sponsored by Coloplast A/S.
- Completed
- Registry status
- 810
- Enrollment target
NCT02162615: Completed study, sponsored by Coloplast A/S.
NCT02162615 is a clinical trial that has completed, run by Coloplast A/S. The registered enrollment target is 810 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02162615 has completed, sponsored by Coloplast A/S.
- COMPLETED
- Registry status
- 810 participants
- Enrollment target
Study Summary
The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their pelvic organ prolapse treatment.
Primary Outcome
Recurrent Prolapse measured anatomically at the target compartment by leading edge of prolapse beyond the hymenal ring by POP-Q examination, or additional surgical treatment for pelvic organ prolapse in the target vaginal compartment(s), or patient reporting symptoms of vaginal bulging.
Interventions
- DEVICE Restorelle Direct Fix A
- DEVICE Restorelle Direct Fix P
- PROCEDURE Native Tissue Repair Anterior
- PROCEDURE Native Tissue Repair Posterior
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 810 participants |
| Start Date | 2014-08 |
| Est. Completion | 2021-11-06 |
What the finished NCT02162615 record still lists
NCT02162615 is an observational study that tracks outcomes without assigning an intervention. The registered 810 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 4 interventions - of which Restorelle Direct Fix A is the first listed.
NCT02162615 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02162615 about?
NCT02162615 is a clinical study titled "Restorelle® Mesh Versus Native Tissue Repair for Prolapse". The purpose of this study is to collect information on the safety and effectiveness of Restorelle Direct Fix mesh and the surgical procedure to implant Restorelle. These results will be compared to the safety and effectiveness results in patients who have native tissue repair (without mesh) as their...
What is the current status of trial NCT02162615?
This trial is currently completed. The enrollment target is 810 participants. The study started on 2014-08. Estimated completion is 2021-11-06.
What interventions are being tested in trial NCT02162615?
The interventions under investigation include: Restorelle Direct Fix A (DEVICE), Restorelle Direct Fix P (DEVICE), Native Tissue Repair Anterior (PROCEDURE), Native Tissue Repair Posterior (PROCEDURE).
Who is sponsoring clinical trial NCT02162615?
This trial is sponsored by Coloplast A/S, which has 21 total clinical trials registered on ClinicalTrials.gov.
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