RecruitingFistula-in-ano
BioHealx® Anal Fistula Device Post Market Surveillance Study
Eligible age
18–75 yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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).
Sponsor: Signum Surgical USA Inc.
You may qualify if…
- ✓ 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.
You may not qualify if…
- ✕ 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
- ✕ Rectal / fistula malignancy
Where it's recruiting
Florida
Fort Myers
New Jersey
Hackensack
New York
New York · Staten Island
Pennsylvania
Bryn Mawr · Danville
Source: ClinicalTrials.gov · NCT07021742 · last updated 2026-06-03