NCT04829058 GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
| NCT ID | NCT04829058 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ethicon, Inc. |
| Condition | Pelvic Organ Prolapse |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-11-24 |
| Primary Completion | 2031-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2021-11-24 with a primary completion date of 2031-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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)
Contact & Investigator
Martin Weisberg, MD
STUDY DIRECTOR
Ethicon, Inc.
Frequently Asked Questions
Who can join the NCT04829058 clinical trial?
This trial is open to female participants only, aged 21 Years or older, studying Pelvic Organ Prolapse. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04829058 currently recruiting?
Yes, NCT04829058 is actively recruiting participants. Contact the research team at cromanow@its.jnj.com for enrollment information.
Where is the NCT04829058 trial being conducted?
This trial is being conducted at North Wales, United States, Pittsburgh, United States, Tübingen, Germany.
Who is sponsoring the NCT04829058 clinical trial?
NCT04829058 is sponsored by Ethicon, Inc.. The principal investigator is Martin Weisberg, MD at Ethicon, Inc.. The trial plans to enroll 100 participants.