BioHealx device long-term follow-up for closing anal fistulas

BioHealx® Anal Fistula Device Post Market Surveillance Study

This study will see if the BioHealx implant can close and keep closed anal fistulas in adults with a single continuous fistula who have had a draining seton.

Quick facts

• Study type: Observational
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Signum Surgical USA Inc. (Industry-sponsored)
• Locations: 5 sites (Fort Myers, Florida and 4 other locations)
• Trial ID: NCT07021742 on ClinicalTrials.gov

What this trial studies

This is a single-arm, multicenter post-market surveillance study testing the BioHealx bioabsorbable device for closure of internal and external openings of fistula-in-ano. Eligible adults will undergo placement of the BioHealx device and be followed over time to document fistula closure durability and safety. The protocol requires prior placement of a draining seton for at least six weeks and regular follow-up visits at participating centers. Data will be collected on closure rates, recurrences, and device-related adverse events.

Who should consider this trial

Good fit: Adults aged 18–75 with a single continuous anal fistula presenting for curative treatment, including patients with failed or recurrent closure who have had a draining seton for at least six weeks and meet other health criteria, are ideal candidates.

Not a fit: Patients with complex or branching fistulas, fistula tract under 2 cm, Crohn's disease, active infection or abscess, significant immunosuppression, pregnancy, a PLGA allergy, or BMI over 35 are unlikely to benefit from this device.

Why it matters

Potential benefit: If successful, the device could provide durable closure of anal fistulas with less invasive treatment and lower recurrence risk, potentially avoiding more extensive surgery.

How similar studies have performed: Similar bioabsorbable plug-type devices have been used for anal fistula closure in prior studies with mixed results—some report modest closure rates but variable long-term durability.

Eligibility criteria

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
* 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 this trial is running

Fort Myers, Florida and 4 other locations

• The Colorectal Institute — Fort Myers, Florida, United States (Recruiting)
• Weill Cornell Medicine — New York, New York, United States (Recruiting)
• Northwell Health — Staten Island, New York, United States (Recruiting)
• Maininle Health Lankenau — Bryn Mawr, Pennsylvania, United States (Recruiting)
• Geisinger — Danville, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Katy Feeny

Conditions Fistula-in-ano