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
Ethicon, Inc.
100 participants
Nov 24, 2021
OBSERVATIONAL
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
Inclusion Criteria5
- Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
- Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse
- GYNEMESH PS Mesh was used as a bridging material according to the IFU.
- Able and willing to participate in follow-up
- Subject or authorized representative has signed the approved informed consent
Exclusion Criteria4
- Subjects meeting any of the following criteria will be considered not eligible for enrollment in this study:
- Subjects < 21 years of age at the time of informed consent
- Subjects who had transvaginal approach for surgery
- Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04829058