Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.
Investigators want to measure degree of leakage on a 4-point scale of SenSura and SenSura test product.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SenSura test product 1pc | Experimental | Subjects randomized to treatment sequence 1test:
|
|
| SenSura 1pc | Experimental | Subjects randomized to treatment sequence 2 test:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SenSura | Device | SenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of leakage | Leakage under and outside the baseplate will be assessed by a 4 point leakage scale. | patients will test the products for 4 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SenSura test product | Device | SenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S |
|