NCT07021742 · Signum Surgical USA Inc.
BioHealx® Anal Fistula Device Post Market Surveillance Study
What this study is about
This post market surveillance study is a single treatment group$1 conducted at multiple hospitals 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).
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Fort Myers, Florida
- Hackensack, New Jersey
- New York, New York
- Staten Island, New York
- Bryn Mawr, Pennsylvania
- Danville, Pennsylvania
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 3, 2026 · Source of record for eligibility and locations