Rectal FistulasFISTULA-RFANCT07452666
FISTULA-RFA Trial: Radiofrequency Ablation for Perianal Fistula
A study testing Radiofrequency Ablation (RFA) for Perianal Fistula in people with Rectal Fistulas, run by Korea University Ansan Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 74 years
- Conditions the study is for
- Rectal Fistulas
- What is being tested?
- Radiofrequency Ablation (RFA) for Perianal Fistula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2026to 30 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Korea University Ansan Hospital IRB Desk contact
About this study
Official title: 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
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.
Read more
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
Read the detailed description
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.
Radiofrequency 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.
Objectives 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.
Methods 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.
Intervention (RFA procedure):
RFA 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.
Follow-up and assessments:
Participants 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.
Endpoints overview:
The 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.
Data analysis:
As 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.
- Conditions
- Rectal Fistulas
- Being tested
- Radiofrequency Ablation (RFA) for Perianal Fistula
- Keywords
- Rectal Fistula, RFA, Minimal Invasive Surgery, Radiofrequency Ablation
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Ablation (RFA) for Perianal FistulaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Radiofrequency Ablation (RFA) for Perianal Fistula |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline(post-procedure) and at 3 and 6 months after RFA
Secondary outcomes (7)
Fistula Recurrence
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.
Measured: Up to 6 months after RFA (assessed at 3 and 6 months)
Time to Fistula Closure
Time from the RFA procedure to first documented clinical closure as defined in the primary outcome criteria.
Measured: Up to 6 months after RFA
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
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.
Measured: From the day of procedure through 6 months after RFA
Change in Pain Severity
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.
Measured: Baseline (pre-procedure), 3 months, and 6 months after RFA
Change in Fecal Continence
Change in continence status assessed by a validated score (Wexner/St. Mark's incontinence score), compared with baseline.
Measured: Baseline, 3 months, and 6 months after RFA
Change in Health-Related Quality of Life
Change in quality of life using a validated patient-reported measure (PROMIS), compared with baseline.
Measured: Baseline, 3 months, and 6 months after RFA
Need for Additional Fistula-Related Intervention
Proportion of participants requiring additional fistula-related procedures or treatments during follow-up (eg, drainage, seton placement, repeat ablation, or surgery).
Measured: Up to 6 months after RFA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion30 Jan 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Rectal FistulasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Ansan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunseok Yoon, Korea University Ansan Hospital
- Investigators
- Kwang Dae Hong, MD, PhD, Professor, Study chair, Department of Colorectal Surgery, Korea University Ansan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452666
- Sponsor's protocol ID
- 2025AS0310
- Acronym
- FISTULA-RFA
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 6016560Keogh 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.
PubMed 26804594Buchanan 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.
PubMed 15714247Lauretta 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.
PubMed 30535666Gupta 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.
PubMed 15543373Schwandner 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.
PubMed 23179892Meinero 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.
PubMed 22002535Wilhelm 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.
PubMed 28271331Adegbola 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.
PubMed 34908858Merlini 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.
PubMed 30897291Sautereau 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.
PubMed 36128714Yoon 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.
PubMed 40044113
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07452666
- Acronym / sponsor ID
- FISTULA-RFA / 2025AS0310
- Conditions
- Rectal Fistulas
- Keywords
- Rectal Fistula, RFA, Minimal Invasive Surgery, Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Korea University Ansan HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 30 Jan 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Radiofrequency 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.
Objectives 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.
Methods 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.
Intervention (RFA procedure):
RFA 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.
Follow-up and assessments:
Participants 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.
Endpoints overview:
The 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.
Data analysis:
As 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency Ablation (RFA) Treatment Arm | Experimental | Device: Radiofrequency Ablation (RFA) for Perianal FistulaParticipants 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. |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency Ablation (RFA) for Perianal FistulaRadiofrequency 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. | Device | Radiofrequency Ablation (RFA) Treatment Arm |
Primary outcome
Fistula Closure (Clinical Healing)
Time frame: Baseline(post-procedure) and at 3 and 6 months after RFA
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.
7 secondary outcomes
Fistula Recurrence
Time frame: Up to 6 months after RFA (assessed at 3 and 6 months)
Time to Fistula Closure
Time frame: Up to 6 months after RFA
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From the day of procedure through 6 months after RFA
Change in Pain Severity
Time frame: Baseline (pre-procedure), 3 months, and 6 months after RFA
Change in Fecal Continence
Time frame: Baseline, 3 months, and 6 months after RFA
Change in Health-Related Quality of Life
Time frame: Baseline, 3 months, and 6 months after RFA
Need for Additional Fistula-Related Intervention
Time frame: Up to 6 months after RFA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Results publication: PubMed 6016560McColl 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.
- Results publication: PubMed 26804594Keogh 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.
- Results publication: PubMed 15714247Buchanan 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.
- Results publication: PubMed 30535666Lauretta 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.
- Results publication: PubMed 15543373Gupta 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.
- Results publication: PubMed 23179892Schwandner 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.
- Results publication: PubMed 22002535Meinero 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.
- Results publication: PubMed 28271331Wilhelm 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.
- Results publication: PubMed 34908858Adegbola 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.
- Results publication: PubMed 30897291Merlini 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.
- Results publication: PubMed 36128714Sautereau 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.
- Results publication: PubMed 40044113Yoon 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.
- Individual participant dataSharing planned: Undecided
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Recruiting
The Use of Electronic Bidets Compared to Water Rinsing After Surgery for Anal Fistula or Haemorrhoidal Disease: a Pilot Study
Anal Fistula Surgery, Anal Fistula
Active, not recruiting
A Study Of Cryptoglandular Fistula-in-ano And Associated Non-healing Draining Wounds With Kerecis SurgiClose
Fistula-in-ano, Draining Wound
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Korea University Ansan Hospital IRB Desk contact
Kwang Dae Hong, MD, PhD, Professor study chair
Department of Colorectal Surgery, Korea University Ansan Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation (RFA) for Perianal Fistula in people with Rectal Fistulas, run by Korea University Ansan Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kwang Dae Hong, MD, PhD, Professor (+82-031-412-4380, drhkd@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fistula Closure (Clinical Healing) (time frame: Baseline(post-procedure) and at 3 and 6 months after RFA). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07452666, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.