BioHealx® Anal Fistula Device Post Market Surveillance Study
ConditionFistula-in-ano
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorSignum Surgical USA Inc.
About this trial
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
Qualifiers
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.
Disqualifiers
Fistula tract shorter than 2cm
Complex fistula tract (branching)
Body Mass Index > 35
Known uncontrolled diabetes or other systemic condition associated with impaired healing
Trial design
Treatments tested in this trial
- BioHealx
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
6The Colorectal Institute33912, Fort MyersFlorida, United States
Hackensack University Medical Center07601, HackensackNew Jersey, United States
Weill Cornell Medicine10021, New YorkNew York, United States
Northwell Health10305, Staten IslandNew York, United States
Sponsors and collaborators
Signum Surgical USA Inc.
Lead sponsor
Source ClinicalTrials.gov