BioHealx device long-term follow-up for closing anal fistulas
Official title: BioHealx® Anal Fistula Device Post Market Surveillance Study
Run by Signum Surgical USA Inc. · NCT07021742 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Signum Surgical USA Inc. Industry-sponsored |
| Locations | 6 sites (Fort Myers, Florida and 5 other locations) |
| Status | Recruiting |
| Started | June 14, 2025 |
| Main results expected | October 2026 |
| Study ends | December 2026 |
| Registry record updated | June 3, 2026 |
| Trial ID | NCT07021742 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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The Colorectal Institute
Fort Myers, Florida, United States Recruiting -
Hackensack University Medical Center
Hackensack, New Jersey, 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
- Email: kjclinconsulting@gmail.com
- Phone: 610-860-6577
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Perianal disease and its impact on sexual life
This project will see how chronic perianal conditions (like fistulas, perianal Crohn’s, or pilonidal disease) affect sexual function and self‑esteem in adults who can complete Greek questionnaires.
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ECMT-100 ECM hydrogel to close high transsphincteric anorectal fistulas
This trial tests a mucoadhesive ECM hydrogel (ECMT-100) placed into the fistula tract to try to close high transsphincteric anorectal fistulas in adults who have had a seton in place.
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Comparing collagen paste and mucosal advancement flap for treating fistula-in-ano
This study tests whether using collagen paste or surgery works better for healing high anal fistulas while keeping the anal sphincter functioning well.
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Evaluating non-cutting seton placement for fistula-in-ano in children
This study tests how long a special thread, called a seton, should be used to treat fistula-in-ano in children to see which duration helps them feel better.
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Using stem cells from umbilical cords to treat perianal fistulas in Crohn's disease patients
This study is testing if injections of stem cells from umbilical cords can safely help people with Crohn's disease heal complex perianal fistulas.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.