Back to resultsEfficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas
Primary Purpose
Perianal Fistulas
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
KULIST
Sponsored by
About this trial
This is an interventional treatment trial for Perianal Fistulas
Eligibility Criteria
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
Sites / Locations
- Malmö University Hospital Dept of Surgery
- Kolorektalsektionen Kirurg -och urologkliniken Danderyds Sjukhus AB
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
KULIST
Arm Description
Medical Device, Activated carbon
Outcomes
Primary Outcome Measures
Clinical evaluation of fistula healing, change from baseline
Fistula assessed as healed/not healed
Secondary Outcome Measures
Anal ultrasonography, change from baseline
Healed/not healed
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
Safety, change from baseline
Standard collection of adverse events and adverse device effects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01462747
Brief Title
Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas
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 Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
January 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordic Drugs AB
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perianal Fistulas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
KULIST
Arm Type
Experimental
Arm Description
Medical Device, Activated carbon
Intervention Type
Device
Intervention Name(s)
KULIST
Intervention Description
Twice daily dosing for 8 weeks
Primary Outcome Measure Information:
Title
Clinical evaluation of fistula healing, change from baseline
Description
Fistula assessed as healed/not healed
Time Frame
week 8 and 24
Secondary Outcome Measure Information:
Title
Anal ultrasonography, change from baseline
Description
Healed/not healed
Time Frame
week 8 and 24
Title
Patient assessment of Symptoms and Impact on Daily Function, change from baseline
Description
By the use of VAS scales and questionnaires the patients subjective evaluations of symptoms and impact on daily living will be assessed
Time Frame
week 8 and 24
Title
Safety, change from baseline
Description
Standard collection of adverse events and adverse device effects.
Time Frame
week 2, 8, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Måns Bohe, MD, PhD
Organizational Affiliation
Skane University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Malmö University Hospital Dept of Surgery
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
Kolorektalsektionen Kirurg -och urologkliniken Danderyds Sjukhus AB
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas
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