BioHealx® Anal Fistula Device Post Market Surveillance Study

Launched by SIGNUM SURGICAL USA INC. · Jun 11, 2025

Keywords

ClinConnect Summary

The BioHealx® Anal Fistula Device Post Market Surveillance Study is a research trial designed to evaluate how well the BioHealx device works over the long term for closing anal fistulas, which are abnormal connections between the anal canal and the skin. This study will include participants who are between 18 and 75 years old and have a specific type of anal fistula that has not healed after previous treatments. To be eligible, patients must have had a draining seton (a type of temporary treatment) in place for at least six weeks and be willing to follow up with the study team.

The trial is not currently recruiting participants, but those who join will help researchers understand the effectiveness of the device in closing fistulas. Participants will need to be available for follow-up visits and must agree to provide consent to be part of the study. It's important to note that individuals with certain health conditions, such as uncontrolled diabetes or those who are pregnant, will not be eligible to participate. Overall, this study aims to gather important information that could help improve treatment options for people suffering from anal fistulas.

Gender

ALL

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