Actively Recruiting
Fistura® Procedure for the Treatment of Complex Anal Fistulas
Led by F Care Systems NV · Updated on 2025-02-25
50
Participants Needed
1
Research Sites
186 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.
CONDITIONS
Official Title
Fistura® Procedure for the Treatment of Complex Anal Fistulas
Who Can Participate
Eligibility Criteria
You may qualify if you...
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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
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Patient ≥ 18 years at study entry
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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
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Patient and investigator signed and dated the informed consent form prior to the procedure
You will not qualify if you...
- Patient < 18 years at study entry
- Patient has a known contraindication to treatment using radiofrequency (infectious anal pathologies, anal fissures, residual Longo anterior treatment staples)
- Patient has a known contraindication to MRI
- 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)
- Patient has a fistula associated with radiation and inflammatory bowel disease
- Patient is unable/unwilling to provide informed consent
- Patient is unable to comply with the protocol or proposed follow-up visits and questionnaires
- Patient is currently participating in another clinical study
- Patient is pregnant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
CHIREC site Braine l'Alleud-Waterloo
Braine-l'Alleud, Belgium, 1420
Actively Recruiting
Research Team
L
Lauren Swinnen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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