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The aim of the current investigation is to develop new soft and more flexible 2-piece convex ostomy appliances
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Coloplast Test product Z; then Coloplast Test product Y | Experimental | The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y |
|
| First Coloplast Test product Y, Then Coloplast Test product Z | Experimental | The subjects first test test product Y and after cross-over test product Z |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Test product Y | Device | Coloplast Test product Y is a newly developed 2-piece convex 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 (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome). The degree of leakage was 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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The subjects were recruited through the danish Coloplast database.
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| ID | Title | Description |
|---|---|---|
| FG000 | First Coloplast Test Product Z; Then Coloplast Test Product Y | The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance |
| FG001 | First Coloplast Test Product Y, Then Coloplast Test Product Z | The subjects first test test product Y and after cross-over test product Z Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex 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 (best possible outcome) and 32 points represents full-plate leakage (worst possible outcome). The degree of leakage was measured at each baseplate change. | Posted | Mean | Standard Deviation | units on a scale | 14 days | baseplate | Participants |
|
The subjects were enrolled for 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 Y | Results from the subjects testing Coloplast Test Y |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peristomal skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Related to device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Daniel Carter | Coloplast | +45 49112523 | dkdac@coloplast.com |
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|
| Coloplast Test product Z | Device | Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance |
|
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| Lack of Efficacy |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
| baseplate |
|
|
| 0 |
| 18 |
| 6 |
| 18 |
| EG001 | Test Z | Results from the subjects testing Coloplast Test Y | 0 | 19 | 8 | 19 |
|
| Peristomal Itching | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Related to device |
|
| Peristomal pain | Skin and subcutaneous tissue disorders | Non-systematic Assessment | related to device |
|
| broken peristomal skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Related to device |
|
| Pimple in peristomal area | Skin and subcutaneous tissue disorders | Non-systematic Assessment | related to device |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment | not related to device |
|
| Fainted | General disorders | Non-systematic Assessment | not related to device |
|
| Headache | General disorders | Non-systematic Assessment | not related to device |
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| Nausea | General disorders | Non-systematic Assessment | not related to device |
|
| wound on right arm | Skin and subcutaneous tissue disorders | Non-systematic Assessment | not related to device |
|
| Fungus infection in mouth | Infections and infestations | Non-systematic Assessment | not related to device |
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| gastritis | Gastrointestinal disorders | Non-systematic Assessment | not related to device |
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| Vomit | Gastrointestinal disorders | Non-systematic Assessment | not related to device |
|
| chills in left side of bag and leg after applying the bag | General disorders | Non-systematic Assessment | 12 times |
|
| skin irritation on leg | Skin and subcutaneous tissue disorders | Non-systematic Assessment | where the bag cover the skin |
|
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