Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01462747|
Recruitment Status : Completed
First Posted : October 31, 2011
Last Update Posted : February 13, 2013
|Condition or disease||Intervention/treatment||Phase|
|Perianal Fistulas||Device: KULIST||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||June 2012|
|Actual Study Completion Date :||January 2013|
Medical Device, Activated carbon
Twice daily dosing for 8 weeks
- Clinical evaluation of fistula healing, change from baseline [ Time Frame: week 8 and 24 ]Fistula assessed as healed/not healed
- Anal ultrasonography, change from baseline [ Time Frame: week 8 and 24 ]Healed/not healed
- Patient assessment of Symptoms and Impact on Daily Function, change from baseline [ Time Frame: week 8 and 24 ]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 ]Standard collection of adverse events and adverse device effects.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|