50
Participants
Start Date
September 1, 2024
Primary Completion Date
March 31, 2028
Study Completion Date
April 30, 2028
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.
RECRUITING
CHIREC site Braine l'Alleud-Waterloo, Braine-l'Alleud
F Care Systems NV
INDUSTRY