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The study evaluates the efficacy of a new 2-piece appliance in patients with colostomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AOS-C2001-B | Experimental | A new 2-piece appliance composed with 2 parts: a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AOS-C2001-B | Device | A new 2-piece appliance composed with 2 parts: a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day) |
| Measure | Description | Time Frame |
|---|---|---|
| Description of efficacy in terms of stool collection and leakage prevention | After each change of the investigational product, the patient will describe on a 4-point scale the type of capsule cap cover removal | At least 1 time per day during 14±3 days |
| Description of efficacy in terms of stool collection and leakage prevention | After each change of the investigational product, the patient will describe on a 4-point scale the level of leakage | At least 1 time per day during 14±3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elie CHOUILLARD | Poissy | 78100 | France |
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