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To investigate the performance and safety of the three 2-piece convex ostomy appliances
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Coloplast Test 1 | Experimental | The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2 Finally the all subject test Coloplast Test 3 |
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| Coloplast Test 2 | Experimental | The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1 Finally the all subject test Coloplast Test 3 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Test 1 | Device | Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Leakage | The degree of leakage was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate) | 14 days |
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Inclusion Criteria:
Subjects interested in participating in the clinical investigation must comply with the following criteria:
Exclusion Criteria:
Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
Have a loop ostomy (also called double-barrel or ostomy with two outlets)
Are pregnant* or breastfeeding.
Currently receiving, or have received within the last 2 months, chemotherapy or radiation therapy.
Currently receiving or have received, within the last month, systemic or local steroid treatment (adrenocortical hormone) in the peristomal area.
Currently suffering from peristomal skin problems (i.e. bleeding or broken skin (weeping skin)).
Known hypersensitivity toward any of the test products
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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 |
The subjects are randomised to two arms
In both arms the subjects start measuring the performance of own product to collect baseline data.
In this arm the subjects are randomised between Coloplast Test1 and Coloplast Test 2
In the third test period all subject test Coloplast Test 3
Subjects are recruited from the Coloplast A/S user database in Denmark.
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| ID | Title | Description |
|---|---|---|
| FG000 | 1st Coloplast Test 1,2nd Coloplast Test 2 3rd Coloplast Test 3 | The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2 Finally the all subject test Coloplast Test 3 Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance |
| FG001 | 1st Coloplast Test 2 2nd Coloplast Test 1 3rd Coloplast Test 3 | The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1 Finally the all subject test Coloplast Test 3 Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Own Product |
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| Test Period 1 |
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| Test Period 2 |
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| Test Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Population |
| Units | Counts |
|---|---|
| Participants |
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| 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 was measured with a 32 -point scale developed by Coloplast A/S, where 0 is the best possible outcome (no leakage) and 32 is the worst possible outcome (full leakage under the baseplate) | Posted | Mean | Standard Deviation | units on a scale | 14 days | baseplates | Participants |
|
October - December 2012
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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 1 | Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Expantion of rectal stenosis | Gastrointestinal disorders | Non-systematic Assessment | The Serious adverse event was not related to the test product |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin irritation | 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 2 | Device | Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance |
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| Coloplast Test 3 | Device | Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Coloplast Test 2 | The subjects are randomised to two arms In both arms the subjects start measuring the performance of own product to collect baseline data. In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1 Finally the all subject test Coloplast Test 3 Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance |
| OG002 | Coloplast Test 3 | Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance |
| OG003 | Baseline - Own Product | The subjects test own product to measure their baseline leakage |
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| 0 |
| 25 |
| 7 |
| 25 |
| EG001 | Coloplast Test 2 | Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance | 1 | 24 | 15 | 24 |
| EG002 | Coloplast Test 3 | Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance | 0 | 22 | 12 | 22 |
| EG003 | Baseline - Own Product | The subjects test own product to measure their baseline leakage | 1 | 26 | 3 | 26 |
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| Heart spams | Cardiac disorders | Non-systematic Assessment | The serious adverse event was not related to own product |
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| Itching of peristomal skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Pain in the peristomal skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Broken skin in peristomal area | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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