Actively Recruiting
GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
Led by Ethicon, Inc. · Updated on 2026-05-08
100
Participants Needed
3
Research Sites
540 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female subjects who underwent 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 Instructions for Use (IFU)
- Able and willing to participate in follow-up
- Subject or authorized representative has signed the approved informed consent
You will not qualify if you...
- Subjects younger than 21 years of age at the time of informed consent
- Subjects who had surgery using a transvaginal approach
- Subjects who underwent a uterus-sparing procedure such as sacrohysteropexy or sacrocervicopexy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Institute for Female Pelvic Medicine
North Wales, Pennsylvania, United States, 19454
Actively Recruiting
2
UMPC
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
3
Universitatsklinikum Tubingen
Tübingen, Germany
Actively Recruiting
Research Team
C
Christine Romanowski
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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