NCT06113068

Fistura® Procedure for the Treatment of Complex Anal Fistulas

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: F Care Systems NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Complex Anal Fistulas

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-09-01
• Primary completion: 2028-03-01
• Completion: 2028-04-01
• First posted: 2023-11-02
• Last updated: 2025-02-25

Locations

1 site across 1 country: Belgium