RecruitingNCT04829058

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

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

Sponsor

Ethicon, Inc.

Enrollment

100 participants

Start Date

Nov 24, 2021

Study Type

OBSERVATIONAL

Conditions

pelvic organ prolapse

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

Sex: FEMALEMin Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Intervention for people with pelvic organ prolapse. The study is currently recruiting participants at 3 locations. People eligible for this study include women aged 21 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntervention

There is no intervention, beyond necessary clinical care, in this study. The surgical procedures that were performed in subjects within this study are identical to the surgical procedures the subjects would have received as part of SOC.

Locations(3)

Institute for Female Pelvic Medicine

North Wales, Pennsylvania, United States

UMPC

Pittsburgh, Pennsylvania, United States

Universitatsklinikum Tubingen

Tübingen, Germany

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NCT04829058

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