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

Perianal Fistulas Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01462747
• Other study ID #: KULIST-001
• Status: Completed
• Phase: Phase 2
• First received: October 21, 2011
• Last updated: February 12, 2013
• Start date: December 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2013
• Source: Nordic Drugs AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fistula
• Perianal Fistulas
• Rectal Fistula

Intervention

Device:
• KULIST
Twice daily dosing for 8 weeks

Locations

Country	Name	City	State
Sweden	Malmö University Hospital Dept of Surgery	Malmö
Sweden	Kolorektalsektionen Kirurg -och urologkliniken Danderyds Sjukhus AB	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Nordic Drugs AB

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical evaluation of fistula healing, change from baseline	Fistula assessed as healed/not healed	week 8 and 24	No
Secondary	Anal ultrasonography, change from baseline	Healed/not healed	week 8 and 24	No
Secondary	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	No
Secondary	Safety, change from baseline	Standard collection of adverse events and adverse device effects.	week 2, 8, 24	Yes