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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-01-31

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.

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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.

Conditions

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Perianal Fistulas

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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KULIST

Medical Device, Activated carbon

Group Type EXPERIMENTAL

KULIST

Intervention Type DEVICE

Twice daily dosing for 8 weeks

Interventions

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KULIST

Twice daily dosing for 8 weeks

Intervention Type DEVICE

Eligibility 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No