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BioHealx® Anal Fistula Device Post Market Surveillance Study

NCT07021742 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2026-04-08

No results posted yet for this study

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).

Conditions

  • Fistula-in-ano

Interventions

DEVICE

BioHealx

Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device, a bioabsorbable implant designed to securely close the fistula internal opening, preventing reinfection, while allowing for drainage through the external opening during healing.

Sponsors & Collaborators

  • Signum Surgical USA Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-14
Primary Completion
2026-10-31
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07021742 on ClinicalTrials.gov