BioHealx® Anal Fistula Device Post Market Surveillance Study
Signum Surgical USA Inc.
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
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age 18 - 75 years * Presence of Single Continuous Anal Fistula presenting for initial curative surgery * Failed or Recurrent Anal Fistula Closure * Minimum of 6-weeks of draining seton placed prior to procedure. * Availability for follow-up contacts and willingness to complete the Informed Consent. Exclusion Criteria: * Fistula tract shorter than 2cm * Complex fistula tract (branching) * Body Mass Index \> 35 * Known uncontrolled diabetes or other systemic condition associated with impaired healing * Known HIV-positive or immunocompromised * Rectal prolapse * Pregnancy…
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.
Locations (5)
- The Colorectal InstituteFort Myers, Florida
- Weill Cornell MedicineNew York, New York
- Northwell HealthStaten Island, New York
- Maininle Health LankenauBryn Mawr, Pennsylvania
- GeisingerDanville, Pennsylvania