An Investigation of Ostomy Devices
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||CP216: An Exploratory Investigation of Convex Ostomy Devices|
- Degree of Leakage [ Time Frame: One week ] [ Designated as safety issue: No ]
The degree of leakage under the baseplate was measured on a 24-point scale where 0 point was the best possible outcome with no leakage under the baseplate and 24-point was the worst possible outcome with leakage under the whole plate.
The scale was developed by Coloplast A/S
|Study Start Date:||September 2011|
|Study Completion Date:||January 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: One arm
The arm consisted of two periods: in period one, products were tested in the order A, B, C, D, and in period two, products were tested in the order A*, B*, C*, D*.
Device: Ostomy appliance: convex 1-piece drainable
8 variations of an ostomy devices are tested
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514136
|Humlebaek, Denmark, 3050|
|Principal Investigator:||Birte P Jakobsen, MD||Coloplast A/S|