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Clinical Performance of the GYNECARE PROLIFT + M* Pelvic Floor Repair System as a Device for Pelvic Organ Prolapse

NCT00833001 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 126

Last updated 2014-05-06

No results posted yet for this study

Summary

The purpose of this study is to evaluate the clinical performance of the PROLIFT system with a new lighter-weight mesh in repair of vaginal prolapse.

Conditions

  • Cystocele
  • Rectocele
  • Enterocele

Interventions

DEVICE

GYNECARE PROLIFT+M* Pelvic Floor Repair System

Pre-shaped mesh implants made of GYNECARE GYNEMESH M composite mesh, comprised of absorbable polyglecaprone 25 monofilament fiber and nonabsorbable polypropylene monofilament fiber

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • David Robinson, MD · Ethicon, Inc.

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2009-11-30
Completion
2011-12-31

Countries

  • Belgium
  • France
  • Germany
  • 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 NCT00833001 on ClinicalTrials.gov