An Investigation of Ostomy Devices

Status Completed

Clinical Trial Summary

Coloplast A/S has developed a new ostomy device in 8 versions.

The primary objective of this investigation is to assess and compare the degree of leakage when using the 8 different devices.

The secondary objective is to investigate several performance and safety parameters of the various devices.

The aim of the primary and secondary objectives is to acquire more knowledge about the performance of the newly developed device and inspiration for their further development, if needed.

Given that the investigation is exploratory, pass/fail criteria are not relevant. The investigation result will provide knowledge useful for continued decision-making/device development.

The investigation is designed as a non-blinded, controlled, exploratory investigation that includes a total of 30-40 Danish ileostomy users.

Each subject will test a maximum of 4 convex devices in two rounds of each 4 weeks. Each device will be tested for 7 (± 2) days.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Ileostomy

Clinical Trial Details

NCT number	NCT01514136
Study type	Interventional
Source	Coloplast A/S
Contact
Status	Completed
Phase	N/A
Start date	September 2011
Completion date	January 2012

View Details

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