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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01462747
First Posted: October 31, 2011
Last Update Posted: February 13, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nordic Drugs AB
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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 ]
    Fistula assessed as healed/not healed


Secondary Outcome Measures:
  • Anal ultrasonography, change from baseline [ Time Frame: week 8 and 24 ]
    Healed/not healed

  • Patient assessment of Symptoms and Impact on Daily Function, change from baseline [ Time Frame: week 8 and 24 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Nordic Drugs AB
ClinicalTrials.gov Identifier: NCT01462747     History of Changes
Other Study ID Numbers: KULIST-001
First Submitted: October 21, 2011
First Posted: October 31, 2011
Last Update Posted: February 13, 2013
Last Verified: February 2013

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