Trials / Completed
CompletedNCT02021279
ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study
Evaluation of the Use of Transvaginal Resorbable Biologic Mesh as Compared to Traditional Non-Mesh Surgical Repair for Treating Pelvic Floor Disorders
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 161 (actual)
- Sponsor
- Integra LifeSciences Corporation · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to assess the safety and effectiveness of MatriStem Pelvic Floor Matrix as compared to native tissue repair for the treatment of pelvic organ prolapse. Patients are evaluated throughout a 3 year follow-up period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MatriStem Pelvic Floor Matrix | |
| PROCEDURE | native tissue repair |
Timeline
- Start date
- 2014-06-11
- Primary completion
- 2021-04-28
- Completion
- 2021-04-28
- First posted
- 2013-12-27
- Last updated
- 2022-02-08
Locations
13 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02021279. Inclusion in this directory is not an endorsement.