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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02021279 on ClinicalTrials.gov