NCT01523756

A Clinical Investigation of New Ostomy Appliances

An Open-labelled Randomized Cross-over and Controlled Exploratory Investigation Comparing Several Variants of a Newly Developed Ostomy Appliance With Regard to Performance in 20 Patients With Ileostomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-labelled randomized cross-over and controlled exploratory intervention that aims to include 20-30 patients with an ileostomy. Every patient is to test two new ostomy appliances each for two weeks. During the test a questionaire is to be filled out and interviews will take place. Primary parameter is leakage. A Study nurse will visit the participants in their homes every two week during the test.

Conditions

• Leakage

Interventions

Type	Name	Description
DEVICE	test product 1: new ostomy base plate with Coloplast as manufacturer	test product 1 is tested first
DEVICE	test product 2: new ostomy base plate with Coloplast as manufacturer	test product 2 is tested first

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2012-02-01
• Last updated: 2014-03-10
• Results posted: 2014-03-10

Locations

1 site across 1 country: Denmark