Performance Study of Newly Developed Ostomy Products

Status Completed

Clinical Trial Summary

The purpose of the study is to evaluate leakage of a newly developed ostomy product compared to standard care in subjects with colostomies. Subjects will be asked to use each test product for 2 weeks - in total, the study period is 4 weeks and the hypothesis is to show that the newly developed ostomy product is significantly better to reduce leakage compared to standard care.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Stoma Colostomy

Clinical Trial Details

NCT number	NCT01513330
Study type	Interventional
Source	Coloplast A/S
Contact
Status	Completed
Phase	Phase 4
Start date	November 2011
Completion date	August 2012

View Details

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