Radiofrequency Using the Fistura® Procedure for the Treatment of Complex Anal Fistulas: Assessing Healing Rate and Anal Incontinence Up to 1 Year Follow-up

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Patient ≥ 18 years at study entry

• 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

• Patient and investigator signed and dated the informed consent form prior to the procedure

Locations
Other Locations
Belgium
CHIREC site Braine l'Alleud-Waterloo
RECRUITING
Braine-l'alleud
Contact Information
Primary
Lauren Swinnen
lauren.swinnen@archerresearch.eu
+32474075921
Time Frame
Start Date: 2024-09-01
Estimated Completion Date: 2028-04
Participants
Target number of participants: 50
Treatments
Experimental: Fistura procedure
Related Therapeutic Areas
Sponsors
Leads: F Care Systems NV

This content was sourced from clinicaltrials.gov

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