Trials / Completed
CompletedNCT02162615
Restorelle® Mesh Versus Native Tissue Repair for Prolapse
Restorelle® Transvaginal Mesh Versus Native Tissue Repair for Treatment of Pelvic Organ Prolapse, Restorelle 522 Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 810 (actual)
- Sponsor
- Coloplast A/S · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Restorelle Direct Fix A | |
| DEVICE | Restorelle Direct Fix P | |
| PROCEDURE | Native Tissue Repair Anterior | |
| PROCEDURE | Native Tissue Repair Posterior |
Timeline
- Start date
- 2014-08-01
- Primary completion
- 2020-01-15
- Completion
- 2021-11-06
- First posted
- 2014-06-13
- Last updated
- 2022-01-27
Locations
49 sites across 6 countries: United States, Australia, Belgium, Canada, France, Netherlands
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02162615. Inclusion in this directory is not an endorsement.