Actively Recruiting
Using the Fistura4 Procedure with Radiofrequency to Treat Complex Anal Fistulas Evaluating Healing and Anal Continence Up to One Year
Led by F Care Systems NV · Updated on 2025-02-25
50
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the healing rate of complex anal fistulas using the Fisturaae procedure, a radiofrequency treatment. The study is designed as a prospective, interventional, single-arm trial at one center. It aims to assess healing and anal incontinence up to one year after treatment in patients with complex fistulas, including certain types that involve significant portions of the sphincter or have multiple tracts. The Fisturaae procedure uses a sterile catheter connected to a radiofrequency generator. The flexible catheter follows the fistulas path to close it without cutting or damaging the sphincter complex, which may help maintain continence. This procedure is performed once, and the study monitors healing and other outcomes over 12 months. Participants will be assessed during an in-hospital visit at 12 months to evaluate healing clinically and by MRI. Additional evaluations of anal incontinence, quality of life, procedure duration, energy used, return to daily activities and work, and complications occur at various time points up to one year. The study involves regular follow-up visits and questionnaires to monitor outcomes and safety throughout the year.
CONDITIONS
Brief Title
Fistura® Procedure for the Treatment of Complex Anal Fistulas
Research Team
L
Lauren Swinnen
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