Actively Recruiting
BioHealx Anal Fistula Device Post Market Surveillance Study Assessing Long-Term Durability and Effectiveness for Fistula-in-Ano Closure
Led by Signum Surgical USA Inc. · Updated on 2026-06-03
50
Participants Needed
6
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term durability and effectiveness of the BioHealx Anal Fistula Device in closing fistula-in-ano, which involves both internal and external fistula openings. This post market surveillance study is a single-arm, multicenter trial designed to observe outcomes after treatment with this device. Participants will have their anal fistula treated with the BioHealx device, a bioabsorbable implant that securely closes the internal fistula opening to prevent reinfection while allowing drainage through the external opening during healing. The study monitors participants over time to assess fistula closure and recurrence rates. During the study, participants will be followed up regularly for up to 36 months. Researchers will measure successful closure repair at 12 months and track non-recurrence incidence at 24 and 36 months. Secondary outcomes include assessments of fecal incontinence quality of life, severity index scores, general health-related quality of life, pain scores, and use of analgesics and antibiotics. Participants will have ongoing evaluations and follow-up contacts to monitor these outcomes.
CONDITIONS
Brief Title
BioHealx® Anal Fistula Device Post Market Surveillance Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 informed consent
You will not qualify if you...
- Fistula tract shorter than 2 cm
- Complex fistula tract (branching)
- Body mass index over 35
- Known uncontrolled diabetes or other systemic condition impairing healing
- Known HIV-positive or immunocompromised status
- Rectal prolapse
- Pregnancy
- Rectal or 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 medication
- 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 making patient unsuitable
- Treatment with investigational drug or medical device in past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single procedure
Participants have their anal fistula treated with the BioHealx Anal Fistula Device, a bioabsorbable implant designed to securely close the fistula internal opening while allowing drainage during healing.
1 visit (in-person)
Duration - Up to 36 months
Participants are followed to assess the long-term durability and effectiveness of the device in fistula closure and quality of life outcomes.
Multiple follow-up visits over 36 months
Trial Site Locations
Total: 6 locations
1
The Colorectal Institute
Fort Myers, Florida, United States, 33912
Actively Recruiting
2
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
3
Weill Cornell Medicine
New York, New York, United States, 10021
Actively Recruiting
4
Northwell Health
Staten Island, New York, United States, 10305
Actively Recruiting
5
Maininle Health Lankenau
Bryn Mawr, Pennsylvania, United States, 19010
Actively Recruiting
6
Geisinger
Danville, Pennsylvania, United States, 17822
Actively Recruiting
Research Team
K
Katy Feeny
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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