Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07452666
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FISTULA-RFA Trial: Radiofrequency Ablation for Perianal Fistula
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012003', 'term': 'Rectal Fistula'}], 'ancestors': [{'id': 'D007412', 'term': 'Intestinal Fistula'}, {'id': 'D016154', 'term': 'Digestive System Fistula'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D005402', 'term': 'Fistula'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-01', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-03-01', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Global Impression of Improvement (PGI-I)', 'timeFrame': '3 months and 6 months after RFA', 'description': 'Patient-reported global improvement using a single-item global rating (PGI-I)'}, {'measure': 'Procedural Feasibility and Technical Success', 'timeFrame': 'During the procedure (day of RFA)', 'description': 'Successful completion of the planned RFA procedure per protocol (eg, ability to access the tract and deliver energy as intended) without intra-procedural device failure.'}, {'measure': 'Procedure Duration', 'timeFrame': 'Day of procedure', 'description': 'Procedure duration, defined as the time recorded in the operative report from the start of the fistula procedure to completion (minutes).'}, {'measure': 'Same-day Discharge', 'timeFrame': 'Day of procedure (post-procedure day 0)', 'description': 'Proportion of participants discharged on the day of the procedure (post-procedure day 0), recorded as Yes/No.'}, {'measure': 'Time to Return to Normal Activity', 'timeFrame': 'Up to 30 days after RFA procedure', 'description': 'Time (days) from the procedure to return to usual/normal daily activities, as reported by the participant.'}], 'primaryOutcomes': [{'measure': 'Fistula Closure (Clinical Healing)', 'timeFrame': 'Baseline(post-procedure) and at 3 and 6 months after RFA', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Fistula Recurrence', 'timeFrame': 'Up to 6 months after RFA (assessed at 3 and 6 months)', 'description': 'Recurrence after initial clinical closure, defined as reappearance of an external opening, recurrent drainage/discharge, or clinical evidence of a fistula tract on examination during follow-up.'}, {'measure': 'Time to Fistula Closure', 'timeFrame': 'Up to 6 months after RFA', 'description': 'Time from the RFA procedure to first documented clinical closure as defined in the primary outcome criteria.'}, {'measure': 'Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From the day of procedure through 6 months after RFA', 'description': 'Number and proportion of participants experiencing procedure- or device-related AEs/SAEs (eg, bleeding, infection/abscess, urinary retention, severe pain requiring intervention, hospitalization, or reoperation), graded by severity and relationship to the procedure/device.'}, {'measure': 'Change in Pain Severity', 'timeFrame': 'Baseline (pre-procedure), 3 months, and 6 months after RFA', 'description': 'Change in patient-reported pain interference compared with baseline, assessed using the PROMIS® Pain Interference - Short Form 8a. The instrument includes 8 items, each scored on a 5-point Likert scale (1=not at all to 5=very much). Item scores are summed to generate a raw total score ranging from 8 to 40, with higher scores indicating worse pain interference. The outcome will be reported as the change in raw total score from baseline at each follow-up time point.'}, {'measure': 'Change in Fecal Continence', 'timeFrame': 'Baseline, 3 months, and 6 months after RFA', 'description': "Change in continence status assessed by a validated score (Wexner/St. Mark's incontinence score), compared with baseline."}, {'measure': 'Change in Health-Related Quality of Life', 'timeFrame': 'Baseline, 3 months, and 6 months after RFA', 'description': 'Change in quality of life using a validated patient-reported measure (PROMIS), compared with baseline.'}, {'measure': 'Need for Additional Fistula-Related Intervention', 'timeFrame': 'Up to 6 months after RFA', 'description': 'Proportion of participants requiring additional fistula-related procedures or treatments during follow-up (eg, drainage, seton placement, repeat ablation, or surgery).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rectal Fistula', 'RFA', 'Minimal Invasive Surgery', 'Radiofrequency Ablation'], 'conditions': ['Rectal Fistulas']}, 'referencesModule': {'references': [{'pmid': '6016560', 'type': 'RESULT', 'citation': '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': '26804594', 'type': 'RESULT', 'citation': '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': '15714247', 'type': 'RESULT', 'citation': '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': '30535666', 'type': 'RESULT', 'citation': "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': '15543373', 'type': 'RESULT', 'citation': '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': '23179892', 'type': 'RESULT', 'citation': "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': '22002535', 'type': 'RESULT', 'citation': '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': '28271331', 'type': 'RESULT', 'citation': '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': '34908858', 'type': 'RESULT', 'citation': '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': '30897291', 'type': 'RESULT', 'citation': "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': '36128714', 'type': 'RESULT', 'citation': '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': '40044113', 'type': 'RESULT', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* How many participants achieve fistula closure by 6 months after RFA treatment?\n* How often do fistulas recur during follow-up?\n* What medical problems or adverse events occur after the RFA procedure (for example, pain, bleeding, infection, urinary retention, or changes in continence)?\n* 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.\n\nParticipants will:\n\n* Be screened and enrolled at one of the participating hospitals\n* Undergo a standardized RFA procedure for the perianal fistula\n* Attend follow-up visits with clinical assessments at regular time points up to 6 months (including key assessments around 3 and 6 months)\n* Report symptoms and any adverse events during the follow-up period', 'detailedDescription': 'Perianal fistula is a chronic inflammatory tract that can cause persistent discharge, pain, recurrent abscess formation, and substantial impairment in daily activities and quality of life. While definitive surgical management aims to eradicate the fistula while preserving sphincter function, conventional approaches may be limited by variable healing rates, risk of recurrence, and concerns regarding sphincter injury and subsequent continence disturbance-particularly in complex fistulas or in patients at higher risk of incontinence. As a result, sphincter-preserving, minimally invasive techniques have been actively explored to improve clinical outcomes while minimizing functional compromise.\n\nRadiofrequency ablation (RFA) is a thermal energy-based modality that can induce controlled tissue coagulation and remodeling. For perianal fistula treatment, RFA has the potential to ablate the fistula tract internally and promote tract closure without dividing sphincter muscles. However, a key challenge in energy-based fistula treatments is achieving consistent and uniform ablation along the entire tract length, because uneven energy delivery may lead to insufficient ablation in certain segments and treatment failure or recurrence. To address this limitation, a novel, dedicated RFA fistula device has been developed to deliver thermal energy in a standardized manner along the tract, with the intent of achieving more uniform ablation across tract segments (ie, segment-by-segment energy delivery rather than focal "dot" ablation). Prior preclinical work using a porcine perianal fistula model was performed to establish feasible operating parameters and to support translation to a first-in-human clinical pilot study.\n\nObjectives The primary objective of this prospective multicenter single-arm pilot study is to evaluate the clinical efficacy of a novel RFA device for the treatment of perianal fistula in adult participants, with clinical fistula closure assessed at 6 months after the procedure. Secondary objectives are to evaluate safety (procedure- and device-related adverse events), recurrence patterns during follow-up, and changes in symptom burden and functional outcomes over time. In addition, this pilot study aims to assess procedural feasibility and to generate data that will inform the design of larger confirmatory studies, including refinement of outcome definitions, follow-up strategy, and operational standardization across sites.\n\nMethods This is a prospective, multicenter, single-arm pilot interventional study enrolling adult participants with perianal fistula who are considered appropriate for a sphincter-preserving approach. All enrolled participants will receive RFA treatment using the dedicated fistula RFA device under a standardized procedural framework across participating sites.\n\nIntervention (RFA procedure):\n\nRFA will be delivered intraluminally to the fistula tract using the dedicated RFA catheter introduced via the external opening according to the standardized technique. The procedure is designed to apply controlled thermal energy along the tract to promote tract closure while minimizing injury to surrounding sphincter structures. Periprocedural management and post-procedure care will follow a harmonized protocol across sites to support consistent implementation and safety monitoring.\n\nFollow-up and assessments:\n\nParticipants will be evaluated longitudinally after the procedure, with key clinical assessments at approximately 3 and 6 months post-procedure (in addition to immediate post-procedure assessment per routine clinical care). Clinical evaluation will include inspection and digital rectal examination to assess fistula healing status and to identify any signs of persistent or recurrent disease. Safety monitoring will include collection and documentation of adverse events from the time of the procedure through the final follow-up assessment, including severity and relationship to the procedure/device. Patient-reported symptoms (including pain) and functional outcomes (including continence-related measures and quality-of-life measures when applicable) will be captured at predefined time points.\n\nEndpoints overview:\n\nThe primary endpoint is clinical fistula closure at 6 months after RFA treatment, based on standardized clinical criteria. Secondary endpoints include recurrence during follow-up, safety outcomes (adverse events/serious adverse events), symptom trajectories (eg, pain), functional outcomes (eg, continence), quality of life measures, and the need for additional fistula-related interventions.\n\nData analysis:\n\nAs a pilot study, analyses will primarily be descriptive and estimation-focused to characterize preliminary efficacy and safety signals. Outcome measures will be summarized using appropriate descriptive statistics, and clinically relevant proportions (eg, closure and recurrence rates) will be reported with confidence intervals where applicable. The resulting data will be used to inform sample size assumptions, endpoint operationalization, and protocol optimization for subsequent larger-scale studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 20 to 74 years\n* Able and willing to provide written informed consent after receiving explanation of the study purpose, procedures, potential benefits, and risks\n* Diagnosed with one or more of the following perianal fistula types:\n\n 1. High trans-sphincteric fistula\n 2. Low trans-sphincteric fistula with high risk of fecal incontinence (sphincter injury risk)\n 3. Fistula with seton placement (seton in situ or previously placed per protocol)\n 4. Crohn's disease-associated perianal fistula\n 5. Complex fistula, including cases with a history of perineal or gynecologic surgery and/or recurrent fistula\n\nExclusion Criteria:\n\n* Superficial fistula that is expected to be curable with simple fistulotomy with minimal risk of sphincter injury\n* Fistula related to malignancy\n* 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"}, 'identificationModule': {'nctId': 'NCT07452666', 'acronym': 'FISTULA-RFA', 'briefTitle': 'FISTULA-RFA Trial: Radiofrequency Ablation for Perianal Fistula', 'organization': {'class': 'OTHER', 'fullName': 'Korea University Ansan Hospital'}, 'officialTitle': 'FISTULA-RFA Trial (Fistula Inactivation by Segmental Thermal Uniform Lesion Ablation-Radiofrequency Ablation): A Prospective, Multicenter, Single-Arm Pilot Study in Patients With Perianal Fistula', 'orgStudyIdInfo': {'id': '2025AS0310'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiofrequency Ablation (RFA) Treatment Arm', 'description': '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.', 'interventionNames': ['Device: Radiofrequency Ablation (RFA) for Perianal Fistula']}], 'interventions': [{'name': 'Radiofrequency Ablation (RFA) for Perianal Fistula', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Radiofrequency Ablation (RFA) Treatment Arm']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Kwang Dae Hong, MD, PhD, Professor', 'role': 'CONTACT', 'email': 'drhkd@korea.ac.kr', 'phone': '+82-031-412-4380'}, {'name': 'Korea University Ansan Hospital IRB Desk', 'role': 'CONTACT', 'phone': '+82-031-412-6520'}], 'overallOfficials': [{'name': 'Kwang Dae Hong, MD, PhD, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Colorectal Surgery, Korea University Ansan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Korea University Ansan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical assistant professor', 'investigatorFullName': 'Sunseok Yoon', 'investigatorAffiliation': 'Korea University Ansan Hospital'}}}}