[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627748":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":20,"responsibleParty":34,"collaborators":20,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":44,"eligibilityCriteria":45,"healthyVolunteers":40,"sex":46,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":20,"studyType":52,"phases":53,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":63,"whyStopped":20,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":20},{"fullName":5,"class":6},"Korea University Ansan Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: Radiofrequency Ablation (RFA) for Perianal Fistula",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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.",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Kwang Dae Hong, MD, PhD, Professor","Department of Colorectal Surgery, Korea University Ansan Hospital","STUDY_CHAIR",[27,31],{"name":23,"role":28,"phone":29,"phoneExt":20,"email":30},"CONTACT","+82-031-412-4380","drhkd@korea.ac.kr",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":20},"Korea University Ansan Hospital IRB Desk","+82-031-412-6520",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Sunseok Yoon","Clinical assistant professor","100627748","fistula-rfa-trial-radiofrequency-ablation-for-perianal-fistula-100627748",false,"NCT07452666","FISTULA-RFA Trial: Radiofrequency Ablation for Perianal Fistula","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","FISTULA-RFA","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\u002For 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","ALL","20 Years","74 Years",{"count":50,"type":51},80,"ESTIMATED","INTERVENTIONAL",[54],"NA","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",[57],"Rectal Fistulas",[59,60,61,62],"Rectal Fistula","RFA","Minimal Invasive Surgery","Radiofrequency Ablation","NOT_YET_RECRUITING","2026-03-01",{"date":66,"type":67},"2026-03-05","ACTUAL",{"date":69,"type":51},"2026-04-01",{"date":71,"type":51},"2027-08-30",{"name":5,"class":6}]