BioHealx® Anal Fistula Device Post Market Surveillance Study
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
United States
Florida
The Colorectal Institute
RECRUITING
Fort Myers
Pennsylvania
Maininle Health Lankenau
RECRUITING
Bryn Mawr
Contact Information
Primary
Katy Feeny
kjclinconsulting@gmail.com
610-860-6577
Time Frame
Start Date: 2025-06-14
Estimated Completion Date: 2026-12
Participants
Target number of participants: 50
Treatments
BioHealx
Subjects will have their anal fistula treated with the BioHealx Anal Fistula Device.
Related Therapeutic Areas
Sponsors
Leads: Signum Surgical USA Inc.