Skip to main content
OpenTrials
Completed

NCT Number: NCT01462747

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Perianal Fistulas

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Malmö University Hospital Dept of Surgery, Malmö, Sweden

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with perianal fistulas diagnosed by clinical examination and evaluated as "not healed/open"
  • Fistula classified as intersphincteric and transsphincteric according to Parks´classification (Parks 1976)
  • Superficial fistula involving a part of the external sphincter muscle
  • Age: ≥18 years and ≤ 75 years
  • Informed consent and/or Letter of Authority (as applicable) obtained

Exclusion criteria

  • Inflammatory Bowel Disease (IBD)
  • Rectovaginal fistulas
  • Rectourethral fistulas
  • Rectovesical fistulas
  • Extra-sphincteric and supra-sphincteric fistula according to Parks´classification
  • Complicated fistulas (eg. horse shoe fistulas) as evaluated by the investigator.
  • Any surgical treatment for perianal fistulas
  • Colorectal and/or anal malignancy
  • Other malignancy requiring active treatment
  • Subcutaneous fistulas not involving any part of the external sphincter
  • Other diseases which as per the investigator's opinion should be contraindicated
  • Subjects who are not able to complete study procedures as per the investigator's opinion

Treatment and study plan

KULIST

Device

Twice daily dosing for 8 weeks

Primary outcomes

  1. Clinical evaluation of fistula healing, change from baseline

    Time frame: week 8 and 24

    Fistula assessed as healed/not healed

Secondary outcomes

  1. Anal ultrasonography, change from baseline

    Time frame: week 8 and 24

    Healed/not healed

  2. 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

  3. Safety, change from baseline

    Time frame: week 2, 8, 24

    Standard collection of adverse events and adverse device effects.

Sponsors and collaborators

Lead sponsor

Nordic Drugs AB

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Oct 31, 2011
Registry last updated
Feb 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.