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RECRUITING
NCT06113068
NA

Fistura® Procedure for the Treatment of Complex Anal Fistulas

Sponsor: F Care Systems NV

View on ClinicalTrials.gov

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

Interventions

DEVICE

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