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 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT03195361
Eligibility Criteria:
Inclusion Criteria:
1. Patient has signed the informed consent form and is willing to participate in the clinical study and data collection.
2. Patient age is between 50 and 75 years old
3. POP-Q: Aa and/or Ba is at least -1
Exclusion Criteria:
1. Patient is pregnant or breastfeeding
2. Patient is suffering from active infection (on antibiotic therapy)
3. Patient is planning vaginal delivery
4. Patient had previous vaginal mesh surgery
5. Patient is in high risk for surgery (evidence of clinically significant cardiovascular, renal, hepatic, coagulatory or respiratory diseases).
6. Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
7. Malignancy.
8. Known hypersensitivity to PEEK and/or polypropylene materials.
9. Participation in another investigational trial that has not completed the primary endpoint or interferes with study participation.
10. Diagnosed with mental or emotional disturbance.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT03195361
Study Brief:
Protocol Section:
NCT03195361