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The purpose was to investigate the performance of a new ostomy device measured with a measuring device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Silent arm | Experimental | The participants test the new Coloplast ostomy device use the product as they usually would. |
|
| Active arm | Experimental | The participants test the tnew Coloplast ostomy device and are guided by the measuring device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast ostomy device | Device | the test product is a newly developed Coloplast ostomy device |
|
| Measure | Description | Time Frame |
|---|---|---|
| wear time (hours) | Wear time is recorded at each baseplate change | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birte P Jakobsen, MD | Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
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The trial starts with a baseline period. After 4 baseplate changes the subjects is randomised into two arms.
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