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).
The BioHealx implant is a small coil made of a material that is absorbed by the body over time. It has been designed to close the fistula. As the fistula heals, the implant gradually dissolves from the body.
The BioHealx device has been cleared for use by the Food and Drug Administration (FDA).
In this study, we will collect information about participants' medical history, the device placement procedure, any side effects, and how the device performs over a 36-month period. After the index procedure, participants will have follow-up visits at 6 weeks, 3 months, 6 months, 9 months, 12 months, 24 months and 36 months. If the study doctor is satisfied that the fistula is healed, some of these visits may be changed to telephone visits.
Inclusion Criteria:
1. Men and women between the ages of 18 to 75.
2. Presence of single continuous anal fistula
3. Minimum of 6-weeks of draining seton in place
Exclusion Criteria:
1. Complex fistula tract (branching)
2. Crohn's Disease or Ulcerative proctisis
3. Known HIV-positive or immunocompromised
4. Known allergy to PLGA material
5. Treatment with an investigational drug or medical device in the past 30 days
Detailed eligibility will be reviewed when contacting the study team.
Upper East Side - Manhattan
Open to Enrollment
