ACell MatriStem Pelvic Floor Matrix Versus Native Tissue Repair, Comparative Study
NCT02021279 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161
Last updated 2022-02-08
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
- Pelvic Organ Prolapse
Interventions
- DEVICE
-
MatriStem Pelvic Floor Matrix
- PROCEDURE
-
native tissue repair
Sponsors & Collaborators
-
Integra LifeSciences Corporation
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-06-11
- Primary Completion
- 2021-04-28
- Completion
- 2021-04-28
Countries
- United States
Study Locations
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