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Recruiting
NCT04829058
GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
Conditions: Pelvic Organ Prolapse
Sex: Female
Ages: 21 Years – N/A
Healthy volunteers: No
Enrollment: 100
Sponsor: Ethicon, Inc.
Location: Institute for Female Pelvic Medicine North Wales Pennsylvania
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
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)
Source: ClinicalTrials.gov (NCT04829058). StuddyBuddy aggregates publicly available trial information.