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Pelvic Organ Prolapse

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

Sponsored by Ethicon, Inc.

About this trial

Last updated 22 days ago

Study ID

ESC_2020_02

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
21+ Years
Female
Female

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 4 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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)

Locations

Location

Status

Recruiting
Recruiting
Recruiting

For more information, view the full study details:

NCT04829058