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FISTULA-RFA Trial: Radiofrequency Ablation for Perianal Fistula

NCT07452666 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-03-05

No results posted yet for this study

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

Conditions

  • Rectal Fistulas

Interventions

DEVICE

Radiofrequency Ablation (RFA) for Perianal Fistula

Radiofrequency ablation (RFA) will be delivered to the fistula tract using a dedicated RFA catheter introduced through the external opening under standardized technique. The procedure aims to apply controlled thermal energy along the tract to promote tract closure while minimizing injury to surrounding sphincter structures. Participants will receive a single RFA treatment per protocol, with post-procedure care and safety monitoring during scheduled follow-up.

Sponsors & Collaborators

  • Korea University Ansan Hospital

    lead OTHER

Principal Investigators

  • Kwang Dae Hong, MD, PhD, Professor · Department of Colorectal Surgery, Korea University Ansan Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-01
Primary Completion
2027-01-30
Completion
2027-08-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07452666 on ClinicalTrials.gov