NCT04829058Recruiting
GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
Ethicon, Inc.
Start Date
11/24/2021
Completion Date
3/31/2032
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 Criteria
Age Range: 21 years to No maximum
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 was used as a bridging material according to the IFU.
3. Able and willing to participate in follow-up
4. 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:
1. Subjects \< 21 years of age at the time of informed consent
2. Subjects who had transvaginal approach for surgery
3. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)
Interventions
DEVICE
Intervention
Conditions
Pelvic Organ Prolapse
Locations
Institute for Female Pelvic Medicine
North Wales, Pennsylvania 19454
United States
UMPC
Pittsburgh, Pennsylvania 15213
United States
Universitatsklinikum Tubingen
Tübingen,
Germany