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Heat therapy may seal troubling anal fistulas without surgery

NCT ID NCT07452666

Disease control Sponsor: Korea University Ansan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This pilot study tests whether a device that delivers controlled heat (radiofrequency ablation) can safely close perianal fistulas—abnormal tunnels between the anal canal and skin. Eighty adults with certain types of fistulas will receive a single RFA treatment. Researchers will check if the fistula closes by 6 months, track any return of the fistula, and monitor for side effects like pain or infection.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Radiofrequency ablation (RFA) device
What this could lead to
If successful, this could offer a new, less invasive treatment option for perianal fistulas that avoids cutting sphincter muscles.
What could go wrong
This is a small, early pilot study with no control group. The procedure may not work for everyone, and risks include pain, bleeding, infection, or changes in bowel control.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

20 to 74 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. High trans-sphincteric fistula 2. Low trans-sphincteric fistula with high risk of fecal incontinence (sphincter injury risk) 3. Fistula with seton placement (seton in situ or previously placed per protocol) 4. Crohn's disease-associated perianal fistula 5. Complex fistula, including cases with a history of perineal or gynecologic surgery and/or recurrent fistula Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

anal fistula

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rectal fistulas

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.