RecruitingNot ApplicableNCT06113068

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

Sponsor

F Care Systems NV

Enrollment

50 participants

Start Date

Sep 1, 2024

Study Type

INTERVENTIONAL

Conditions

Complex Anal Fistulas

Summary

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Fistura® procedure for people with complex anal fistulas. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEFistura® 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

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NCT06113068