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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT04007250
Eligibility Criteria:
Inclusion Criteria:
* Individuals being treated with the FENIX™ Continence Restoration System
* Individuals who have provided appropriate authorization per institutional policy and procedure to have clinical and health information collected for the FENIX Registry.
* Individuals willing to complete a 14-day bowel diary, questionnaires and comply with all required follow-up.
Exclusion Criteria:
* Known circumstances that would make it unlikely for an individual to complete the five-year follow-up (e.g. life expectancy \<5 years)
Sex:
ALL
Study:
NCT04007250
Study Brief:
Protocol Section:
NCT04007250