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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT01380132
Eligibility Criteria:
Inclusion Criteria:
* Incontinence to loose or solid stool at least once weekly (Millers incontinence score 6-12).
* Age 18-80
* Available for follow-up for the duration of the study
* Written informed consent.
Exclusion Criteria:
* Sphincter defect visible on anal ultrasound.
* Pregnancy.
* Rectal prolapse or inflammatory bowel disease.
* Recent (within 6 months) anal surgery except for haemorrhoids.
* Anorectal sepsis.
* Anticoagulant medication or bleeding diathesis.
Healthy Volunteers:
False
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01380132
Study Brief:
Protocol Section:
NCT01380132