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:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07452666
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 20 to 74 years
* Able and willing to provide written informed consent after receiving explanation of the study purpose, procedures, potential benefits, and risks
* Diagnosed with one or more of the following perianal fistula types:
1. High trans-sphincteric fistula
2. Low trans-sphincteric fistula with high risk of fecal incontinence (sphincter injury risk)
3. Fistula with seton placement (seton in situ or previously placed per protocol)
4. Crohn's disease-associated perianal fistula
5. Complex fistula, including cases with a history of perineal or gynecologic surgery and/or recurrent fistula
Exclusion Criteria:
* Superficial fistula that is expected to be curable with simple fistulotomy with minimal risk of sphincter injury
* Fistula related to malignancy
* Any contraindication to RFA, including: History of stapled hemorrhoidopexy, Presence of endoscopic clips (or similar metallic clips) within the anal canal, Fecal diversion with stoma (diverting stoma in place), Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
74 Years
Study:
NCT07452666
Study Brief:
Protocol Section:
NCT07452666