GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
ConditionPelvic Organ Prolapse
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age21+
SponsorEthicon, Inc.
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Intervention
Treatment groups
No treatment groups listed
Sponsors and collaborators
Source ClinicalTrials.gov