BioHealx® Anal Fistula Device Post Market Surveillance Study
Recruiting now
Conditions studied: Fistula-in-ano
In brief
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).
Key facts
- Study ID
- NCT07021742
- Run by
- Signum Surgical USA Inc.
- People needed
- 50
- Starts
- 2025-06-14
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2026-06-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
- Crohn's disease
- Ulcerative proctitis
- Hidradenitis suppurativa of the anal region
- Pilonidal sinus disease
- Presence of hemorrhoid Involving fistula site
- Continuous use of anti-inflammatory
- Intersphincteric fistula in ano or fistula treatable by simple fistulotomy
- Active infection or abscess involving fistula site
- Known allergy to PLGA material
- Any severe acute or uncontrolled chronic disease that according to the investigator might render the patient unsuitable for the study
- Treatment with an investigational drug or medical device in the past 30 days
Where it is running
- The Colorectal Institute — Fort Myers, Florida, United States (enrolling)
- Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
- Weill Cornell Medicine — New York, New York, United States (enrolling)
- Northwell Health — Staten Island, New York, United States (enrolling)
- Maininle Health Lankenau — Bryn Mawr, Pennsylvania, United States (enrolling)
- Geisinger — Danville, Pennsylvania, United States (enrolling)
Full record on ClinicalTrials.gov
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