Clinical Investigation for New Filter to Ostomy Bags
The aim of the current clinical investigation is to evaluate a new filter.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Clinical Investigation of Filter Improvement for New Filter to Ostomy Bags|
- Frequency of Ballooning in the Morfeus and SenSura Test Period. [ Time Frame: Daily or at every change of bag in a period of a maximum of 28 days ] [ Designated as safety issue: No ]Data will not be recorded at specific time points due to individual changing patterns (1-3 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period.
|Study Start Date:||January 2011|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Active Comparator: SenSura
The reference product is the CE marked and launched SenSura product which is commercially available
The CE marked ostomy bag filter will be tested for a period of 14 days
Other Name: SenSura
The test product is the product with the proposed new Morfeus filter
The new ostomy bag filter (called Morfeus) will be tested for a period of 14 days
Other Name: Morfeus
The new filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01273038
|Humlebaek, Denmark, 3050|
|Study Chair:||Daniel Carter, MSc||Coloplast A/S|