NCT01462747

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Nordic Drugs AB · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Perianal Fistulas

Interventions

Type	Name	Description
DEVICE	KULIST	Twice daily dosing for 8 weeks

Timeline

• Start date: 2011-12-01
• Primary completion: 2012-06-01
• Completion: 2013-01-01
• First posted: 2011-10-31
• Last updated: 2013-02-13

Locations

2 sites across 1 country: Sweden