At a glance
ClinicalIndex Comparison RecordN/ACompleted· 86 enrolled
Drug / intervention
Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas
In Brief
A clinical study evaluating Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP) and Flap for Anal Fistula. Completed, enrolled 86 participants across 6 sites.
Detailed Summary
The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAnal Fistula
CountriesGermany
CollaboratorsCook Biotech Incorporated, Cook Ireland, Ltd.
Timeline
N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 2007
Enrollment StartJun 2008
Primary CompletionApr 2013
TodayJul 2026
First PostedOct 17, 2007
Enrollment StartJun 1, 2008
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 18.7 years ago
Interventions
Surgisis Biodesign Anal Fistula Plug (Surgisis® AFP)device
Surgical placement of the Surgisis AFP is performed under general anesthesia.
Flapdevice
Advancement flap surgery is performed; no anal fistula plug is placed