GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Description

The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.

Conditions

Pelvic Organ Prolapse

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Study Overview

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Study Details

Study overview

The objective of this retrospective and prospective, single-arm, observational, multicenter, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.

A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Condition
Pelvic Organ Prolapse
Intervention / Treatment

-

Contacts and Locations

North Wales

Institute for Female Pelvic Medicine, North Wales, Pennsylvania, United States, 19454

Pittsburgh

UMPC, Pittsburgh, Pennsylvania, United States, 15213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse
  • 2. GYNEMESH PS Mesh was used as a bridging material according to the IFU.
  • 3. Able and willing to participate in follow-up
  • 4. Subject or authorized representative has signed the approved informed consent
  • 1. Subjects \< 21 years of age at the time of informed consent
  • 2. Subjects who had transvaginal approach for surgery
  • 3. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)

Ages Eligible for Study

21 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ethicon, Inc.,

Martin Weisberg, MD, STUDY_DIRECTOR, Ethicon, Inc.

Study Record Dates

2032-03-31