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:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2025-12-24 @ 11:47 PM
NCT ID:
NCT02921451
Eligibility Criteria:
Inclusion Criteria:
1. Subject is female.
2. Subject is at least 18 years of age.
3. Subjects who have already made the decision to proceed with uterine prolapse surgery using Restorelle Mesh.
4. Subject has uterine prolapse defined by Prolapse Quantification System Assessment (POPQ) score of C -2 or greater.
5. Subject reports a bothersome bulge they can see or feel per Pelvic Floor Distress Inventory Short Form 20 (PFDI-20) question 3, response of 2 or higher (i.e. response of "somewhat", "moderately" or "quite a bit").
6. Subject is willing to provide written informed consent.
7. Subject is willing and able to comply with follow-up regimen.
Exclusion Criteria:
1. Subject is pregnant or intends to become pregnant in the future.
2. Subject has a history of pelvic organ cancer (e.g. uterine, ovarian, bladder or cervical).
3. Subject has undergone any previous repair for pelvic organ prolapse.
4. Subject has undergone a hysterectomy.
5. Subject lacks competency of the English language.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT02921451
Study Brief:
Protocol Section:
NCT02921451