Clinical Trial

FISTULA-RFA Trial: Radiofrequency Ablation for Perianal Fistula

Study acronym: FISTULA-RFA
Not Yet Recruiting
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Summary
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
Trial Details
NCT Number NCT07452666
Lead Sponsor Korea University Ansan Hospital
Conditions Rectal Fistulas
Enrollment 80 participants
Start Date 2026-04-01
Primary Completion 2027-01-30 (estimated)
Study Completion 2027-08-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-05