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 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT06363903
Eligibility Criteria:
Inclusion Criteria:
* Patients \>18 years of age and written informed consent obtained;
* Suspected ASIA syndrome after elective hernia, pelvic organ prolapse (POP) surgery, or stress urinary incontinence (SUI) repair, defined as three major ASIA criteria (Table 1), of which the exposure to an external stimulus (PP mesh) is one;
* ASIA complaints evolved after the implantation of PP mesh and were not present before the surgical repair.
Exclusion Criteria:
* Known auto-immune disorders;
* Known malignancies;
* (Low grade) infections or other inflammatory diseases at time of surgery;
* Cognitively impaired individuals.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06363903
Study Brief:
Protocol Section:
NCT06363903