RecruitingNCT07021742

BioHealx® Anal Fistula Device Post Market Surveillance Study

Sponsor

Signum Surgical USA Inc.

Enrollment

50 participants

Start Date

Jun 14, 2025

Study Type

OBSERVATIONAL

Conditions

Fistula in Ano

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).

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called BioHealx for people with fistula in ano. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEBioHealx

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.