FISTULA-RFA Trial: Radiofrequency Ablation for Perianal Fistula

Starting soon · Not applicable

Conditions studied: Rectal Fistulas

In brief

The goal of this pilot clinical study is to learn whether radiofrequency ablation (RFA) can safely and effectively treat perianal fistulas in adults. It will also evaluate procedure-related safety and changes in symptoms over time. The main questions it aims to answer are: * How many participants achieve fistula closure by 6 months after RFA treatment? * How often do fistulas recur during follow-up? * What medical problems or adverse events occur after the RFA procedure (for example, pain, bleeding, infection, urinary retention, or changes in continence)? * How do patient-reported outcomes (such as pain and quality of life) change after treatment? This is a prospective, multicenter, single-arm pilot study. All participants will receive RFA treatment; there is no comparison (control) group. Participants will: * Be screened and enrolled at one of the participating hospitals * Undergo a standardized RFA procedure for the perianal fistula * Attend follow-up visits with clinical assessments at regular time points up to 6 months (including key assessments around 3 and 6 months) * Report symptoms and any adverse events during the follow-up period

Key facts

Study ID

NCT07452666

Run by

Korea University Ansan Hospital

People needed

80

Starts

2026-04-01

Expected to finish

2027-08-30

Last updated by the study team

2026-03-05

Who can join

Age: 20 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• High trans-sphincteric fistula
• Low trans-sphincteric fistula with high risk of fecal incontinence (sphincter injury risk)
• Fistula with seton placement (seton in situ or previously placed per protocol)
• Crohn's disease-associated perianal fistula
• Complex fistula, including cases with a history of perineal or gynecologic surgery and/or recurrent fistula

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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