Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06113068

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  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

Not Eligible

You will not qualify if you...

  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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

CHIREC site Braine l'Alleud-Waterloo

Braine-l'Alleud, Belgium, 1420

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here