Clinical Trial

BioHealx® Anal Fistula Device Post Market Surveillance Study

Recruiting
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Summary
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).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-06-11; most recent amendment 2026-06-02.
Status change: Not Yet Recruiting → Recruiting 2025-08-14
Trial Details
NCT Number NCT07021742
Lead Sponsor Signum Surgical USA Inc.
Conditions Fistula-in-ano
Enrollment 50 participants
Start Date 2025-06-14
Primary Completion 2026-10 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-03