NCT04829058 · Ethicon, Inc.
GYNEMESH PS Mesh Post Marketing Clinical Follow-Up Study
What this study is about
The objective of this reviewing past data and forward-looking, single-treatment group$1, observational, conducted at multiple hospitals, post-market study is to evaluate outcomes in women who underwent surgery for vaginal or uterine prolapse with a GYNEMESH PS Mesh.
View original scientific description
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
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects who satisfy all of the following criteria will be considered eligible for enrollment in this study:
- 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 meeting any of the following criteria will be considered not eligible for enrollment in this study:
- 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)
Where
- North Wales, Pennsylvania
- Pittsburgh, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 6, 2026 · Source of record for eligibility and locations