Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT04829058
Eligibility Criteria:
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
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)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT04829058
Study Brief:
Protocol Section:
NCT04829058