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

Status Completed

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.

Clinical Trial 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 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

• NCT number: NCT01462747
• Study type: Interventional
• Source: Nordic Drugs AB
• Status: Completed
• Phase: Phase 2
• Start date: December 2011
• Completion date: January 2013