Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT04829058

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Sponsor: Ethicon, Inc.

View on ClinicalTrials.gov

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.

Official title: A Retrospective and Long-Term Prospective Post Market Clinical Follow-up (PMCF) Study of the GYNECARE GYNEMESH® PS Nonabsorbable PROLENE® Soft Mesh

Key Details

Gender

FEMALE

Age Range

21 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2021-11-24

Completion Date

2032-03-31

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

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.

Locations (3)

Institute for Female Pelvic Medicine

North Wales, Pennsylvania, United States

UMPC

Pittsburgh, Pennsylvania, United States

Universitatsklinikum Tubingen

Tübingen, Germany