RecruitingNot Applicable

GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study

United States, Germany100 participantsStarted 2021-11-24

Plain-language 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.

Who can participate

Age range21 Years

SexFEMALE

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Inclusion criteria

✓. Female subjects who had laparotomic or laparoscopic abdominal sacrocolpopexy, including robotic-assisted, for apical vaginal or uterine prolapse
✓. GYNEMESH PS Mesh was used as a bridging material according to the IFU.
✓. Able and willing to participate in follow-up
✓. Subject or authorized representative has signed the approved informed consent

Exclusion criteria

✕. Subjects \< 21 years of age at the time of informed consent
✕. Subjects who had transvaginal approach for surgery
✕. Had undergone a uterus-sparing procedure (sacrohystero or sacrocervicopexy)

What they're measuring

Physical examination with Pelvic Organ Prolapse Quantification (POP-Q) Assessment CHange

Timeframe: Post-surgery through study completion, approximately 7 yrs

Trial details

NCT IDNCT04829058

SponsorEthicon, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2031-09-30

Contact for this trial

Christine Romanowski

908-808-6219 cromanow@its.jnj.com

View on ClinicalTrials.gov More Pelvic Organ Prolapse trials