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NCT04829058Recruiting

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Ethicon, Inc.

Start Date

11/24/2021

Completion Date

3/31/2032

Summary

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.

Eligibility Criteria

Age Range: 21 years to No maximum

Inclusion Criteria: Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study: 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 Exclusion Criteria Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study: 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)

Interventions

DEVICE

Intervention

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Conditions

Pelvic Organ Prolapse

Locations

Institute for Female Pelvic Medicine

North Wales, Pennsylvania 19454

United States

UMPC

Pittsburgh, Pennsylvania 15213

United States

Universitatsklinikum Tubingen

Tübingen,

Germany