Status: Recruiting
BioHealx® Anal Fistula Device Post Market Surveillance Study
This post market surveillance study is a single arm multicenter study to demonstrate the long-term durability and effectiveness of the BioHealx Anal Fistula Device for fistula-in-ano closure (internal and external fistula openings).
Participants needed: 50
Trial details
Age: 18-75Biological sex: AllType: ObservationalSponsor: Signum Surgical USA Inc.Updated: Jun 3, 2026Locations: 6Duration: 36 Months
Eligibility criteria
Age 18 - 75 years [+4]
Fistula tract shorter than 2cm [+18]