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

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

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

Study Overview

• Status: Completed
• Conditions: Perianal Fistulas
• Intervention / Treatment: Device: KULIST

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, 205 02
    • Malmö University Hospital Dept of Surgery
  • Stockholm, Sweden, 182 88
    • Kolorektalsektionen Kirurg -och urologkliniken Danderyds Sjukhus AB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KULIST; Medical Device, Activated carbon	Device: KULIST; Twice daily dosing for 8 weeks

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nordic Drugs AB
• Investigators: Principal Investigator: Måns Bohe, MD, PhD, Skåne University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: October 27, 2011
• First Posted (Estimate): October 31, 2011

Study Record Updates

• Last Update Posted (Estimate): February 13, 2013
• Last Update Submitted That Met QC Criteria: February 12, 2013
• Last Verified: February 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: KULIST-001