Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas

Study Overview
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Brief Summary
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The aim of this study is to evaluate the effects of rectally administered activated carbon (medical device KULIST) in chronic, uncomplicated, perianal fistulas.

Detailed Description
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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.

Official Title
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An Open Prospective Study Evaluating the Efficacy and Safety of a Medical Device,KULIST, for the Treatment of Chronic, Non-complicated Perianal Fistulas

Conditions
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Perianal Fistulas

Intervention / Treatment
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* Device: KULIST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with perianal fistulas diagnosed by clinical examination and evaluated as not healed/open Fistula classified as intersphincteric and transsphincteric according to Parks´classification (Parks 1976) Superficial fistula involving a part of the external sphincter muscle Age: ≥18 years and ≤ 75 years Informed consent and/or Letter of Authority (as applicable) obtained Exclusion Criteria Inflammatory Bowel Disease (IBD) Rectovaginal fistulas Rectourethral fistulas Rectovesical fistulas Extra-sphincteric and supra-sphincteric fistula according to Parks´classification Complicated fistulas (eg. horse shoe fistulas) as evaluated by the investigator. Any surgical treatment for perianal fistulas Colorectal and/or anal malignancy Other malignancy requiring active treatment Subcutaneous fistulas not involving any part of the external sphincter Other diseases which as per the investigator's opinion should be contraindicated Subjects who are not able to complete study procedures as per the investigator's opinion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KULIST<br>Medical Device, Activated carbon | Device: KULIST<br>* Twice daily dosing for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical evaluation of fistula healing, change from baseline | Fistula assessed as healed/not healed | week 8 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anal ultrasonography, change from baseline | Healed/not healed | week 8 and 24 | 
| Patient assessment of Symptoms and Impact on Daily Function, change from baseline | By the use of VAS scales and questionnaires the patients subjective evaluations of symptoms and impact on daily living will be assessed | week 8 and 24 | 
| Safety, change from baseline | Standard collection of adverse events and adverse device effects. | week 2, 8, 24 |