NCT07021742 BioHealx® Anal Fistula Device Post Market Surveillance Study
| NCT ID | NCT07021742 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Signum Surgical USA Inc. |
| Condition | Fistula-in-ano |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-14 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-06-14 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07021742 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Fistula-in-ano. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07021742 currently recruiting?
Yes, NCT07021742 is actively recruiting participants. Contact the research team at kjclinconsulting@gmail.com for enrollment information.
Where is the NCT07021742 trial being conducted?
This trial is being conducted at Fort Myers, United States, Hackensack, United States, New York, United States, Staten Island, United States and 2 additional locations.
Who is sponsoring the NCT07021742 clinical trial?
NCT07021742 is sponsored by Signum Surgical USA Inc.. The trial plans to enroll 50 participants.