Zapping fistulas without cutting muscle
NCT ID NCT06113068
First seen Sep 09, 2026 · Last updated Sep 10, 2026 · Updated 1 time
Summary
Researchers are testing a procedure called Fistura that uses radiofrequency energy to close complex anal fistulas. A flexible catheter follows the fistula tract and heats the tissue along its length, aiming to seal the tract without cutting the sphincter muscle. The trial enrolls 50 people with complex fistulas and tracks healing and bowel control for up to a year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiofrequency energy delivered by the Fistura catheter
- What this could lead to
- If it works, this could offer a sphincter-sparing option for complex anal fistulas, potentially healing the tract while preserving bowel control.
- What could go wrong
- This is a small, single-center study with no comparison group, so results may not generalize. Fistulas can persist or return, and the procedure may not heal every type of complex tract.
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
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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
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Apr 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: 1. Patients with complex fistulas Complex fistulas include trans-sphincteric fistulas involving more than 30% of the external sphincter, supra-sphincteric fistulas, extra-sphincteric fistulas, horseshoe fistulas, fistulas involving multiple tracts (according to the ASCRS) and fistulas with a curved tract or a tract presenting diverticula, for which: Suppuration is described by the patient and/or visible by an opening in the anal margin or by anoscopy Clinical symptoms led to an MRI demonstrating the path Fistula path demonstrated in the acute phase during drainage of an abscess 2. Patient ≥ 18 years at study entry 3. Patients with a previously drained fistula, without diverticula \> 10 mm, without T2 hyperintensity (assessed by MRI). Drainage is achieved by placing a seton, usually from 10 weeks to 12 months prior to the procedure 4. Patient and investigator signed and dated the informed consent form prior to the procedure Exclusion Criteria: 1. Patient \< 18 years at study entry 2. Patient has a known contraindication to treatment using radiofrequency (infectious anal pathologies, anal fissures, residual Longo anterior treatment staples) 3. Patient has a known contraindication to MRI 4. Simple fistulas defined as inter-sphincteric or trans-sphincteric, involving less than 30% of the total height of the sphincter apparatus (attested by MRI, ASCRS classification) 5. Patient has a fistula associated with radiation and inflammatory bowel disease 6. Patient is unable/unwilling to provide informed consent 7. Patient is unable to comply with the protocol or proposed follow-up visits and questionnaires 8. Patient is currently participating in another clinical study 9. Patient is pregnant
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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CHIREC site Braine l'Alleud-Waterloo
RECRUITINGBraine-l'Alleud, 1420, Belgium
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