GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Part of paid clinical trials in North Wales, Pennsylvania.

Sponsor
Ethicon, Inc.
Study ID
NCT04829058
Status
Recruiting
Apply to this trial

Conditions

  • Pelvic Organ Prolapse

Eligibility Criteria

Sex
FEMALE
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intervention — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Nov 24, 2021
Status verified
Jun 2026
Primary completion
Sep 30, 2031
Completion
Mar 31, 2032

Study Design

Enrollment
100 participants (estimated)

Primary Outcome Measure

Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange [ Time Frame: Post-surgery through study completion, approximately 7 yrs ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Institute for Female Pelvic MedicineNorth WalesPennsylvania19454-
UMPCPittsburghPennsylvania15213-

Find similar trials in North Wales, PA

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Institute for Female Pelvic Medicine· North Wales, PAUMPC· Pittsburgh, PA

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