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Fistura® Procedure for the Treatment of Complex Anal Fistulas
Sponsor: F Care Systems NV
Summary
This study aims to evaluate the healing rate of complex fistulas using radiofrequency (Fistura® procedure), in a prospective, interventional, monocenter, single-arm design.
Official title: Radiofrequency Using the Fistura® Procedure for the Treatment of Complex Anal Fistulas: Assessing Healing Rate and Anal Incontinence Up to 1 Year Follow-up
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2024-09-01
Completion Date
2028-04
Last Updated
2025-02-25
Healthy Volunteers
No
Conditions
Interventions
Fistura® procedure
The Fistura® procedure is performed using a sterile Fistura® catheter (F Care Systems), intended to be connected to an F Care Systems radiofrequency generator (MedRF4000®). The flexible Fistura® catheters used during the procedure allow it to follow the path of the anal fistula, facilitating the closure of the fistula along its entire length. As the catheter can treat fistulas involving the sphincter complex, but without cutting or damaging it, it is expected to be effective in term of continence maintenance.
Locations (1)
CHIREC site Braine l'Alleud-Waterloo
Braine-l'Alleud, Belgium