Fistura® Procedure for the Treatment of Complex Anal Fistulas

Inclusion Criteria:

1. Patients with complex fistulas Complex fistulas include trans-sphincteric fistulas involving more than 30% of theexternal sphincter, supra-sphincteric fistulas, extra-sphincteric fistulas,horseshoe fistulas, fistulas involving multiple tracts (according to the ASCRS) andfistulas 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 analmargin or by anoscopy Clinical symptoms led to an MRI demonstrating the path Fistulapath 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 T2hyperintensity (assessed by MRI). Drainage is achieved by placing a seton, usuallyfrom 10 weeks to 12 months prior to the procedure

4. Patient and investigator signed and dated the informed consent form prior to theprocedure

Exclusion Criteria:

1. Patient < 18 years at study entry

2. Patient has a known contraindication to treatment using radiofrequency (infectiousanal 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 lessthan 30% of the total height of the sphincter apparatus (attested by MRI, ASCRSclassification)

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 andquestionnaires

8. Patient is currently participating in another clinical study

9. Patient is pregnant