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Safety and Performance Investigation of a New 1-piece Ostomy Product Compared to Standard of Care 1-piece in Subjects With Ileostomy

Ileostomy - Stoma Clinical Trial

Official title:
An Open-labeled, Randomised, Controlled, Comparative, Cross-over Study Investigating the Safety and Performance of a New 1-piece Ostomy Product Compared to Standard Care 1-piece in Subjects With Ileostomy

Clinical Trial Summary

The objective of the investigation is to document New Mio 1-piece is non-inferior (no worse) in reducing leakage (4-point scale) compared to Standard of Care.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01994863
Study type Interventional
Source Coloplast A/S
Contact
Status Terminated
Phase Phase 2
Start date September 2012
Completion date November 2012
View Details
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