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The aim of this study is to investigate the influence of the adhesive wafer design on the products ability to fit to the body..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test A, Test B, Comparator | Experimental | The subjects first test Coloplast Test A followed by Coloplast Test B and finally Comparator. |
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| Test A, Comparator, Test B | Experimental | The subjects first test Coloplast Test A followed by Comparator and finally Coloplast Test B. |
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| Test B, Test A, Comparator | Experimental | The subjects first test Coloplast Test B followed by Coloplast Test A and finally Comparator. |
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| Test B, Comparator, Test A | Experimental | The subjects first test Coloplast Test B followed by Comparator and finally Coloplast Test B. |
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| Comparator, Test A, Test B | Experimental | The subjects first test Comparator followed by Coloplast Test A and then Coloplast Test B |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test A | Device | Test A is a new 1-piece ostomy appliance developed by Coloplast A/S |
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| Measure | Description | Time Frame |
|---|---|---|
| Fit to body | Subjects will evaluate the fit to body for each product by answering the question "How was the base plates ability to fit the body contours in the area around the stoma?" The question is answered with a 5-point scale ranging from Very Poor - Very Good (1-5), where the very poor (1) is the worst possible score and very good (5) is the best possible score. | 14 +/- 2 days |
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Inclusion Criteria:
To participate in the study, it is mandatory that the subject fulfill all inclusions criteria:
Exclusion Criteria:
Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
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| Name | Affiliation | Role |
|---|---|---|
| Khalid Abd-Elaziz, MD | QPS Netherlands | Principal Investigator |
| Susanne Eyre, MD | Synexus North East, United Kingdom | Principal Investigator |
| Gillian Hopkins | Cheltenham General Hospital, United Kingdom | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS Netherlands | Groningen | 9713 | Netherlands | |||
| Synexus Thames Valley |
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| Comparator, Test B, Test A | Experimental | The subjects first test Comparator followed by Coloplast Test B and then Coloplast Test A. |
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| Test B | Device | Test B is a new 1-piece ostomy appliance developed by Coloplast A/S |
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| Comparator | Device | Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available. Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed. |
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| Berkshire |
| RG2 0TG |
| United Kingdom |
| Synexus Midlands | Birmingham | B15 2SQ | United Kingdom |
| Synexus Wales | Cardiff | CF14 5GJ | United Kingdom |
| Synexus Scotland | Glasgow | G20 0SP | United Kingdom |
| Cheltenham General Hospital | Gloucestershire | G1537AN | United Kingdom |
| Synesxus Lancashire | Lancashire | PR7 7NA | United Kingdom |
| Synexus Merseyside | Liverpool | L22 0LG | United Kingdom |
| Synexus Manchester | Manchester | M15 6SX | United Kingdom |
| Synexus North East | Northumberland | NE46 1QJ | United Kingdom |