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Safety and Performance of New 1-piece Ostomy Product

Stoma Ileostomy Clinical Trial

Official title:
Investigating the Safety and Performance of New 1-piece Ostomy Product Concepts Compared With SenSura 1-piece in Subjects With an Ileostomy

Clinical Trial Summary

The aim of the the current investigation is to develop new soft and more flexible 1-piece ostomy products.

Clinical Trial Description

The present investigation aims at testing the degree of leakage with the new flexible 1-piece ostomy products as well as other performance and safety parameters. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01800916
Study type Interventional
Source Coloplast A/S
Contact
Status Completed
Phase N/A
Start date February 2013
Completion date May 2013
View Details
See also
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