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The aim of the current investigation is to develop new soft and more flexible 1-piece convex ostomy products.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FirstColplast Test V, Then Coloplast Test X | Experimental | The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X |
|
| First Coloplast Test X, Then Coloplast Test V | Experimental | The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Test V | Device | Coloplast Test product V is a newly developed 1-piece ostomy appliance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Leakage | The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome). The degree of leakage is measured 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 | Coloplast A/S | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | FirstColplast Test V, Then Coloplast Test X | The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance |
| FG001 | First Coloplast Test X, Then Coloplast Test V | The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test Period 1 |
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| Test Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects |
| 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 | The degree of leakage is measured using a 32-point scale developed by Coloplast A/S, where 0 represents No leakage (the best possible outcome) and 32 points represents full plate leakage (worst possible outcome). The degree of leakage is measured at each baseplate change | Posted | Mean | Standard Deviation | units on a scale | 14 days | baseplates | Participants |
|
28+/- 3 days
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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 | Test V | The results presented for the subjects testing Coloplast Test V |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| constipation | Gastrointestinal disorders | Non-systematic Assessment | Not related to device |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| peristomal skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | related to device ( AE categorised ad unlikely-, possibly-, probably--and definitely- related are defined as related AEs) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Carter | Coloplast | +45 49222523 | dkdac@coloplast.com |
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|
| Coloplast Test X | Device | Coloplast Test X is a newly developed 1-piece ostomy appliance |
|
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| baseplates |
|
|
| 1 |
| 31 |
| 13 |
| 31 |
| EG001 | Test X | the results presented for the subjects testing Test X | 1 | 29 | 13 | 29 |
|
| Absess in the bowl ( by a fistel channel 2 mm from stoma) | Gastrointestinal disorders | Non-systematic Assessment |
|
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| Peristomal Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment | related to the device |
|
| Peristomal skin Pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| broken skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Petekkie/pressure mark (peristomal) | Skin and subcutaneous tissue disorders | Non-systematic Assessment | related to device |
|
| Pain and sorness by stoma and´in bowl | Gastrointestinal disorders | Non-systematic Assessment | Not related to device |
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| Obstipation | Gastrointestinal disorders | Non-systematic Assessment | Not related to device |
|
| dehydration due to obstpation | Metabolism and nutrition disorders | Non-systematic Assessment |
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| fatigue | General disorders | Non-systematic Assessment |
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| Pain in bowl | Gastrointestinal disorders | Non-systematic Assessment | not related to device |
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| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | not related to device |
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| Nausea | General disorders | Non-systematic Assessment | not related to device |
|
| sore throat | Infections and infestations | Non-systematic Assessment | not related to device |
|
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