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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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18 February 2013 |
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Main ID: |
NCT01462747 |
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Date of registration:
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21/10/2011 |
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Primary sponsor: |
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Public title:
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Efficacy and Safety Study of a Medical Device (KULIST)to Treat Perianal Fistulas
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Scientific 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 |
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Date of first enrolment:
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December 2011 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01462747 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Måns Bohe, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Skane University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Patients with perianal fistulas diagnosed by clinical examination and evaluated as
"not healed/open"
2. Fistula classified as intersphincteric and transsphincteric according to
Parks´classification (Parks 1976)
3. Superficial fistula involving a part of the external sphincter muscle
4. Age: =18 years and = 75 years
5. Informed consent and/or Letter of Authority (as applicable) obtained
Exclusion Criteria
6. Inflammatory Bowel Disease (IBD)
7. Rectovaginal fistulas
8. Rectourethral fistulas
9. Rectovesical fistulas
10. Extra-sphincteric and supra-sphincteric fistula according to Parks´classification
11. Complicated fistulas (eg. horse shoe fistulas) as evaluated by the investigator.
12. Any surgical treatment for perianal fistulas
13. Colorectal and/or anal malignancy
14. Other malignancy requiring active treatment
15. Subcutaneous fistulas not involving any part of the external sphincter
16. Other diseases which as per the investigator's opinion should be contraindicated
17. Subjects who are not able to complete study procedures as per the investigator's
opinion
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Perianal Fistulas
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Intervention(s)
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Device: KULIST
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Primary Outcome(s)
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Clinical evaluation of fistula healing, change from baseline
[Time Frame: week 8 and 24]
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Secondary Outcome(s)
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Anal ultrasonography, change from baseline
[Time Frame: week 8 and 24]
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Patient assessment of Symptoms and Impact on Daily Function, change from baseline
[Time Frame: week 8 and 24]
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Safety, change from baseline
[Time Frame: week 2, 8, 24]
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Secondary ID(s)
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KULIST-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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