Trials / Recruiting
RecruitingNCT07021742
BioHealx® Anal Fistula Device Post Market Surveillance Study
- Status
- Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Signum Surgical USA Inc. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-06-14
- Primary completion
- 2026-10-01
- Completion
- 2026-12-01
- First posted
- 2025-06-15
- Last updated
- 2026-04-08
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07021742. Inclusion in this directory is not an endorsement.