BioHealx® Anal Fistula Device Post Market Surveillance Study
NCT ID: NCT07021742
Last Updated: 2025-09-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
50 participants
OBSERVATIONAL
2025-06-14
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Long-term Follow-up of Anal Fistula Plug
NCT03961984
A Prospective European Post-Market Clinical Evaluation of the CuraSeal Percutaneous Intraluminal Closure System for Anorectal Fistulas
NCT02456324
Study Evaluating the Safety and Efficacy of an ECM Hydrogel for the Treatment of Anorectal Fistulas
NCT07035925
Retrospective Review of the Cook Biodesign® Fistula Plug to Treat Anorectal Fistulas
NCT03321266
Success Rate, Continence, and Quality of Life With a Bioprosthetic Plug for Treating Complex Anal Fistula
NCT01612195
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
BioHealx
Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device.
BioHealx
Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device, a bioabsorbable implant designed to securely close the fistula internal opening, preventing reinfection, while allowing for drainage through the external opening during healing.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
BioHealx
Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device, a bioabsorbable implant designed to securely close the fistula internal opening, preventing reinfection, while allowing for drainage through the external opening during healing.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Signum Surgical USA Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Colorectal Institute
Fort Myers, Florida, United States
Maininle Health Lankenau
Bryn Mawr, Pennsylvania, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
J Neale, MD
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SP002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.