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 groupSponsors and collaborators
Source ClinicalTrials.gov