FISTULA-RFA Trial: Radiofrequency Ablation for Perianal Fistula

NCT07452666 | Not Yet Recruiting DMC

• 1 other identifier: 2025AS0310
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Rectal Fistula; RFA; Minimal Invasive Surgery; Radiofrequency Ablation

Outcome Measures

Primary Outcomes (1)

• Fistula Closure (Clinical Healing)

  Fistula closure will be determined by clinical assessment, defined as: (1) complete epithelialization/absence of the external opening on inspection, (2) no drainage/discharge (spontaneous or on gentle pressure), and (3) no clinically apparent fistula tract opening on digital rectal examination (DRE). Symptom improvement (including reduced pain) will be recorded as supportive patient-reported information.

  Baseline(post-procedure) and at 3 and 6 months after RFA

Secondary Outcomes (7)

• Fistula Recurrence

  Up to 6 months after RFA (assessed at 3 and 6 months)

• Time to Fistula Closure

  Up to 6 months after RFA

• Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  From the day of procedure through 6 months after RFA

• Change in Pain Severity

  Baseline (pre-procedure), 3 months, and 6 months after RFA

• Change in Fecal Continence

  Baseline, 3 months, and 6 months after RFA

Other Outcomes (5)

• Patient Global Impression of Improvement (PGI-I)

  3 months and 6 months after RFA

• Procedural Feasibility and Technical Success

  During the procedure (day of RFA)

• Procedure Duration

  Day of procedure

Study Arms (1)

Radiofrequency Ablation (RFA) Treatment Arm

EXPERIMENTAL

Participants in this single-arm, prospective multicenter pilot study will undergo radiofrequency ablation (RFA) for treatment of perianal fistula using a standardized procedural protocol across sites. Clinical outcomes and safety will be assessed longitudinally through follow-up, with the primary clinical assessment at 6 months after the procedure.

Device: Radiofrequency Ablation (RFA) for Perianal Fistula

Interventions

Radiofrequency Ablation (RFA) for Perianal Fistula DEVICE

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.

Radiofrequency Ablation (RFA) Treatment Arm

Eligibility Criteria

• Age: 20 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Korea University Ansan Hospital: lead

Related Publications (12)

• McColl I. The comparative anatomy and pathology of anal glands. Arris and Gale lecture delivered at the Royal College of Surgeons of England on 25th February 1965. Ann R Coll Surg Engl. 1967 Jan;40(1):36-67. No abstract available.

  PMID: 6016560 RESULT

• Keogh KM, Smart NJ. The proposed use of radiofrequency ablation for the treatment of fistula-in-ano. Med Hypotheses. 2016 Jan;86:39-42. doi: 10.1016/j.mehy.2015.11.019. Epub 2015 Nov 26.

  PMID: 26804594 RESULT

• Buchanan GN, Sibbons P, Osborn M, Bartram CI, Ansari T, Halligan S, Cohen CR. Experimental model of fistula-in-ano. Dis Colon Rectum. 2005 Feb;48(2):353-8. doi: 10.1007/s10350-004-0769-7.

  PMID: 15714247 RESULT

• Lauretta A, Falco N, Stocco E, Bellomo R, Infantino A. Anal Fistula Laser Closure: the length of fistula is the Achilles' heel. Tech Coloproctol. 2018 Dec;22(12):933-939. doi: 10.1007/s10151-018-1885-z. Epub 2018 Dec 8.

  PMID: 30535666 RESULT

• Gupta PJ. Radiofrequency fistulotomy: a better alternative for treating low anal fistula. Sao Paulo Med J. 2004 Jul 1;122(4):172-4. doi: 10.1590/s1516-31802004000400008. Epub 2004 Nov 9.

  PMID: 15543373 RESULT

• Schwandner O. Video-assisted anal fistula treatment (VAAFT) combined with advancement flap repair in Crohn's disease. Tech Coloproctol. 2013 Apr;17(2):221-5. doi: 10.1007/s10151-012-0921-7. Epub 2012 Nov 23.

  PMID: 23179892 RESULT

• Meinero P, Mori L. Video-assisted anal fistula treatment (VAAFT): a novel sphincter-saving procedure for treating complex anal fistulas. Tech Coloproctol. 2011 Dec;15(4):417-22. doi: 10.1007/s10151-011-0769-2. Epub 2011 Oct 15.

  PMID: 22002535 RESULT

• Wilhelm A, Fiebig A, Krawczak M. Five years of experience with the FiLaC laser for fistula-in-ano management: long-term follow-up from a single institution. Tech Coloproctol. 2017 Apr;21(4):269-276. doi: 10.1007/s10151-017-1599-7. Epub 2017 Mar 7.

  PMID: 28271331 RESULT

• Adegbola SO, Sahnan K, Tozer P, Warusavitarne J. Emerging Data on Fistula Laser Closure (FiLaC) for the Treatment of Perianal Fistulas; Patient Selection and Outcomes. Clin Exp Gastroenterol. 2021 Dec 6;14:467-475. doi: 10.2147/CEG.S269464. eCollection 2021.

  PMID: 34908858 RESULT

• Merlini l'Heritier A, Siproudhis L, Bessi G, Le Balc'h E, Wallenhorst T, Bouguen G, Brochard C. Sphincter-sparing surgery for complex anal fistulas: radiofrequency thermocoagulation of the tract is of no help. Colorectal Dis. 2019 Aug;21(8):961-966. doi: 10.1111/codi.14618. Epub 2019 Apr 3.

  PMID: 30897291 RESULT

• Sautereau M, Bouchard D, Brochard C, Pigot F, Siproudhis L, Fayette JM, Train C, Laurain A, Favreau C, Abramowitz L. Prospective and multicentre study of radiofrequency treatment in anal fistula. Colorectal Dis. 2023 Feb;25(2):289-297. doi: 10.1111/codi.16344. Epub 2022 Oct 12.

  PMID: 36128714 RESULT

• Yoon S, Choi JW, Son Y, Lee HS, Hong KD. Preclinical testing of a new radiofrequency ablation device in a porcine perianal fistula model. Ann Coloproctol. 2025 Feb;41(1):84-92. doi: 10.3393/ac.2024.00626.0089. Epub 2025 Feb 26.

  PMID: 40044113 RESULT

MeSH Terms

Conditions

Rectal Fistula

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Kwang Dae Hong, MD, PhD, Professor

  Department of Colorectal Surgery, Korea University Ansan Hospital

  STUDY CHAIR

Central Study Contacts

Kwang Dae Hong, MD, PhD, Professor

CONTACT

+82-031-412-4380; drhkd@korea.ac.kr

Korea University Ansan Hospital IRB Desk

CONTACT

+82-031-412-6520

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Model Details: This is a prospective, multicenter, single-arm pilot study with a single group assignment. All enrolled participants will receive radiofrequency ablation (RFA) for perianal fistula using a standardized procedure. Outcomes will be assessed longitudinally through follow-up visits up to 6 months after treatment.

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: March 5, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): August 30, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-02