Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Prospective Study Evaluating the Efficacy and Safety of a Medical Device,KULIST, for the Treatment of Chronic, Non-complicated Perianal Fistulas|
- Clinical evaluation of fistula healing, change from baseline [ Time Frame: week 8 and 24 ] [ Designated as safety issue: No ]Fistula assessed as healed/not healed
- Anal ultrasonography, change from baseline [ Time Frame: week 8 and 24 ] [ Designated as safety issue: No ]Healed/not healed
- Patient assessment of Symptoms and Impact on Daily Function, change from baseline [ Time Frame: week 8 and 24 ] [ Designated as safety issue: No ]By the use of VAS scales and questionnaires the patients subjective evaluations of symptoms and impact on daily living will be assessed
- Safety, change from baseline [ Time Frame: week 2, 8, 24 ] [ Designated as safety issue: Yes ]Standard collection of adverse events and adverse device effects.
|Study Start Date:||December 2011|
|Study Completion Date:||January 2013|
|Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Medical Device, Activated carbon
Twice daily dosing for 8 weeks
Patients with chronic uncomplicated perianal fistulas located below levator ani will be treated twice daily with KULIST for 8 weeks. The efficacy will be evaluated by means of an overall clinical evaluation of fistula closure, as well as by anal ultrasonography.
Also changes in Patient Assessment of Symptoms and Impact on Daily Function will be evaluated. Safety will be evaluated by standard adverse event /adverse device effects reporting.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462747
|Malmö University Hospital Dept of Surgery|
|Malmö, Sweden, 205 02|
|Kolorektalsektionen Kirurg -och urologkliniken Danderyds Sjukhus AB|
|Stockholm, Sweden, 182 88|
|Principal Investigator:||Måns Bohe, MD, PhD||Skane University Hospital|