Trials / Recruiting
RecruitingNCT04829058
GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Ethicon, Inc. · Industry
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2021-11-24
- Primary completion
- 2031-09-30
- Completion
- 2032-03-31
- First posted
- 2021-04-02
- Last updated
- 2026-04-13
Locations
3 sites across 2 countries: United States, Germany
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04829058. Inclusion in this directory is not an endorsement.