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To assess the functionality and safety of the test products and also assess the products ability to collect stool without interfering with the stoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coloplast Test A, Coloplast Test B, Own product | Experimental | The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days |
|
| Coloplast Test C , Coloplast Test D, Own product | Experimental | The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Test A | Device | Coloplast Test A is a new ostomy appliance developed by Coloplast A/S |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Leakage | Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome). | 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 |
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28 subjects were randomized. However 2 subject were wrongly randomized. 1 subject was allocated to test Test D in the First period,1 subject First tested Test A followed by Test D.
Two subject discontinued the testing of the new test products collected data on own product.
These factors disturb the participant flow chart.
The subject were recruited through the Danish Coloplast user data base.
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| ID | Title | Description |
|---|---|---|
| FG000 | Coloplast Test A, Coloplast Test B, Own Product | The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others. |
| FG001 | Coloplast Test C , Coloplast Test D, Own Product | The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others. Coloplast Test C: Coloplast Test C is a new ostomy appliance developed by Coloplast A/S Coloplast Test D: Coloplast Test D is a new ostomy appliance developed by Coloplast A/S |
| FG002 | Coloplast Test D, Coloplast Test C, Own Product | The subjects first test Coloplast Test D and thereafter Coloplast Test C and finally their own product for 14 days Coloplast Test D: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S Coloplast Test C: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others. |
| FG003 | Oloplast Test A, Coloplast Test D, Own Product | The subjects first test Coloplast Test A and thereafter Coloplast Test D and finally their own product for 14 days Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S Coloplast Test D: Coloplast Test D is a newly developed ostomy appliance developed by Coloplast A/S Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Test Period (Test A or Test C) |
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| ||||||||||||||||||
| Second Test Period (Test B or Test D) |
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| Third Test Period (Own Product) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Degree of Leakage | Degree of leakage is measured on a 24 point scale where 0 represents no leakage (best possible outcome) and 24 represents leakage on the whole plate (worst possible outcome). | Posted | Mean | Standard Deviation | units on a scale | 14 days | baseplates | baseplates |
|
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15 A=14 Coloplast TestA, Coloplast TestB..+1 Oloplast TestA, Coloplast TestD.. 7 B=7 Coloplast TestA, Coloplast TestB..(2nd period) 12 C=12 Coloplast TestC, Coloplast TestD.. 10 D=8 Coloplast TestC, Coloplast TestD..(2nd period)+1 Oloplast Test A, Coloplast Test D..(2nd period)+1 Coloplast Test D..
16 own product=7 Coloplast Test A, Coloplast Test B..+8 Coloplast Test C, Coloplast Test D..+1 Oloplast Test A, Coloplast Test D..(incl. 2, not completing 2nd period, collecting own product data)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Coloplast Test A | Subjects testing Test A |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hydronephrosis | Renal and urinary disorders | Non-systematic Assessment | The serious adverse event was not related to the investigational device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| peristomal skin problem | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Birte Petersen Jakobsen, MD | Coloplast A/S | +45 4911 1395 | dkbir@coloplast.com |
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| Coloplast Test B | Device | Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S |
|
| Own product | Device | Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others. |
|
| Coloplast Test C | Device | Coloplast Test C is a new ostomy appliance developed by Coloplast A/S |
|
| Coloplast Test D | Device | Coloplast Test D is a new ostomy appliance developed by Coloplast A/S |
|
| Withdrawal by Subject |
|
| Adverse Event |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG003 | Coloplast Test D | Subjects testing Test D |
| OG004 | Own Product | Subjects collecting data on own product |
|
|
| 0 |
| 15 |
| 5 |
| 15 |
| EG001 | Coloplast Test B | Subjects testing Test B | 0 | 7 | 0 | 7 |
| EG002 | Coloplast Test C | Subjects testing Test C | 0 | 12 | 6 | 12 |
| EG003 | Coloplast Test D | Subjects testing Test D | 1 | 10 | 3 | 10 |
| EG004 | Own Product | Subjects collecting data on own product | 0 | 16 | 0 | 16 |
|
| Wound peristomal skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Itching peristomal skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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