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 @ 2:01 AM
Ignite Modification Date:
2025-12-25 @ 2:01 AM
NCT ID:
NCT01673360
Eligibility Criteria:
Inclusion Criteria:
* Patients must meet all of the following criteria to be considered for inclusion in the registry.
* Have a signed Informed Consent Form
* Have a signed HIPAA Authorization Form or equivalent Patient Privacy Form if required outside of the US
* Is a female at least 18 years of age
* Is scheduled to receive at least one (1) AMS market approved female pelvic health implantable product.
* Is able and willing to participate in the registry
Exclusion Criteria:
* Patients will be excluded from the registry if any one of the following criteria is met.
* Patients are contraindicated to receive the target AMS market approved female pelvic health product per the product's IFU
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01673360
Study Brief:
Protocol Section:
NCT01673360