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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nordic Drugs AB
ClinicalTrials.gov Identifier:
NCT01462747
First received: October 21, 2011
Last updated: February 12, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Perianal Fistulas
 Device: KULIST
 Phase 2

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

Resource links provided by NLM:

MedlinePlus related topics: Fistulas
U.S. FDA Resources

Further study details as provided by Nordic Drugs AB:

Primary Outcome Measures:
  • Clinical evaluation of fistula healing, change from baseline [ Time Frame: week 8 and 24 ] [ Designated as safety issue: No ]
    Fistula assessed as healed/not healed


Secondary Outcome Measures:
  • Anal ultrasonography, change from baseline [ Time Frame: week 8 and 24 ] [ Designated as safety issue: No ]
    Healed/not healed

  • Patient assessment of Symptoms and Impact on Daily Function, change from baseline [ Time Frame: week 8 and 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: week 2, 8, 24 ] [ Designated as safety issue: Yes ]
    Standard collection of adverse events and adverse device effects.


Enrollment: 28
Study Start Date: December 2011
Study Completion Date: January 2013
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: KULIST
Medical Device, Activated carbon
 Device: KULIST
Twice daily dosing for 8 weeks

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01462747

Locations
Sweden
Malmö University Hospital Dept of Surgery
Malmö, Sweden, 205 02
Kolorektalsektionen Kirurg -och urologkliniken Danderyds Sjukhus AB
Stockholm, Sweden, 182 88
Sponsors and Collaborators
Nordic Drugs AB
Investigators
Principal Investigator: Måns Bohe, MD, PhD Skane University Hospital
  More Information

No publications provided

Responsible Party: Nordic Drugs AB
ClinicalTrials.gov Identifier: NCT01462747     History of Changes
Other Study ID Numbers: KULIST-001
Study First Received: October 21, 2011
Last Updated: February 12, 2013
Health Authority: Sweden: Medical Products Agency

Additional relevant MeSH terms:
Fistula
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
 Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 19, 2013