GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
NCT ID: NCT04829058
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2021-11-24
2032-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Intervention
There is no intervention, beyond necessary clinical care, in this study. The surgical procedures that were performed in subjects within this study are identical to the surgical procedures the subjects would have received as part of SOC.
Eligibility Criteria
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Inclusion Criteria
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
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)
21 Years
FEMALE
No
Sponsors
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Ethicon, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Martin Weisberg, MD
Role: STUDY_DIRECTOR
Ethicon, Inc.
Locations
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Institute for Female Pelvic Medicine
North Wales, Pennsylvania, United States
UMPC
Pittsburgh, Pennsylvania, United States
Universitatsklinikum Tubingen
Tübingen, , Germany
Countries
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Central Contacts
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Other Identifiers
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ESC_2020_02
Identifier Type: -
Identifier Source: org_study_id