Post Market Study of the BioHealx Anal Fistula Device for Treating Fistula-in-Ano Evaluating Long-Term Effectiveness and Safety in Adults

What this Trial Is About

Researchers are evaluating the long-term durability and effectiveness of the BioHealx Anal Fistula Device in closing fistula-in-ano, which involves both internal and external fistula openings. This post market surveillance study is a single-arm, multicenter trial designed to observe outcomes after treatment with this device. Participants will have their anal fistula treated with the BioHealx device, a bioabsorbable implant that securely closes the internal fistula opening to prevent reinfection while allowing drainage through the external opening during healing. The study monitors participants over time to assess fistula closure and recurrence rates. During the study, participants will be followed up regularly for up to 36 months. Researchers will measure successful closure repair at 12 months and track non-recurrence incidence at 24 and 36 months. Secondary outcomes include assessments of fecal incontinence quality of life, severity index scores, general health-related quality of life, pain scores, and use of analgesics and antibiotics. Participants will have ongoing evaluations and follow-up contacts to monitor these outcomes.

BioHealx® Anal Fistula Device Post Market Surveillance Study