Status:
RECRUITING
GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
Lead Sponsor:
Ethicon, Inc.
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
21+ years
Brief 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 wi...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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 Criteria
- 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)
Exclusion
Key Trial Info
Start Date :
November 24 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2032
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04829058
Start Date
November 24 2021
End Date
March 31 2032
Last Update
December 5 2025
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Institute for Female Pelvic Medicine
North Wales, Pennsylvania, United States, 19454
2
UMPC
Pittsburgh, Pennsylvania, United States, 15213
3
Universitatsklinikum Tubingen
Tübingen, Germany