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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 is a clinical trial that has completed, run by Coloplast A/S. The registered enrollment target is 810 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02162615
The ClinicalTrials.gov registry entry for NCT02162615 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 810 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Coloplast A/S, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Restorelle Direct Fix A is the first listed.
NCT02162615 reports 0 study locations.
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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