At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating test product 1: new ostomy base plate with Coloplast as manufacturer and test product 2: new ostomy base plate with Coloplast as manufacturer for Leakage. Completed, enrolled 20 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
test product 1 is tested first
test product 2 is tested first