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Restorelle® Mesh Versus Native Tissue Repair for Prolapse

NCT02162615 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 810

Last updated 2022-01-27

No results posted yet for this 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.

Conditions

  • Pelvic Organ Prolapse

Interventions

DEVICE

Restorelle Direct Fix A

DEVICE

Restorelle Direct Fix P

PROCEDURE

Native Tissue Repair Anterior

PROCEDURE

Native Tissue Repair Posterior

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Jan-Paul Roovers, MD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2020-01-15
Completion
2021-11-06
FDA Device
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • France
  • Netherlands

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 NCT02162615 on ClinicalTrials.gov