At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-labelled, Randomized, Controlled, Comparative, Single Country (Denmark), Explorative, Cross-over Study Investigating the Performance and Safety of New 1-piece Open Ostomy Appliances Compared to Standard Care 1-piece Open Ostomy Appliances in 25 Subjects With Ileostomy
In Brief
A clinical study evaluating Coloplast Test product 1, Coloplast Test product 2, and 1 other intervention for Ileostomy - Stoma. Completed, enrolled 25 participants across 1 site.
Detailed Summary
To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured
Study Details
Timeline
Interventions
Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.
Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S
Standard Care was the subject usual ostomy appliance and had to be one of the following: * Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut, * Dansac: Nova 1 \& Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate * Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate * ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate * B. Braun: Flexima Active \& Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate