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GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
Sponsor: Ethicon, Inc.
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.
Official title: A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh
Key Details
Gender
FEMALE
Age Range
21 Years - Any
Study Type
OBSERVATIONAL
Enrollment
100
Start Date
2021-11-24
Completion Date
2032-03-31
Last Updated
2026-03-13
Healthy Volunteers
No
Conditions
Interventions
Intervention
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