Actively Recruiting
BioHealx® Anal Fistula Device Post Market Surveillance Study
Led by Signum Surgical USA Inc. · Updated on 2026-04-08
50
Participants Needed
5
Research Sites
76 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 the Informed Consent.
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The Colorectal Institute
Fort Myers, Florida, United States, 33912
Actively Recruiting
2
Weill Cornell Medicine
New York, New York, United States, 10021
Actively Recruiting
3
Northwell Health
Staten Island, New York, United States, 10305
Actively Recruiting
4
Maininle Health Lankenau
Bryn Mawr, Pennsylvania, United States, 19010
Actively Recruiting
5
Geisinger
Danville, Pennsylvania, United States, 17822
Actively Recruiting
Research Team
K
Katy Feeny
CONTACT
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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