Fistura® Procedure for the Treatment of Complex Anal Fistulas

NARecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

September 1, 2024

Primary Completion Date

March 31, 2028

Study Completion Date

April 30, 2028

Conditions
Complex Anal Fistulas
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.

Trial Locations (1)

1420

RECRUITING

CHIREC site Braine l'Alleud-Waterloo, Braine-l'Alleud

All Listed Sponsors
lead

F Care Systems NV

INDUSTRY