GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
Recruiting
Observational Study
Pelvic Organ Prolapse
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 21 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 100 (estimated)
- Sponsor
- Ethicon, Inc. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
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 w…
Contacts