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To investigate the performance and safety of two newly developed convex 1-piece ostomy appliances
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Coloplast Test 1 | Experimental | The subjects first test their own product to collect a baseline measurement The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2 |
|
| First Coloplast Test 2 | Experimental | The subjects first test their own product to collect baseline measurements The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Test 1 | Device | Coloplast Test 1 is a newly developed 1-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 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate) | 14 days |
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Inclusion Criteria:
Subjects must comply with the following criteria in order to participate in the investigation:
Exclusion Criteria:
Subjects complying with the following criteria must be excluded from participation in the clinical investigation:
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| Name | Affiliation | Role |
|---|---|---|
| Kalid S Abd-Elaziz, MD | QPS Holdings LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| QPS | Groningen | 9713 | Netherlands |
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The subject were recruited through the Coloplast database in The Netherlands
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| ID | Title | Description |
|---|---|---|
| FG000 | First Coloplast Test 1, Then Coloplast Test 2 | The subjects first test their own product to collect a baseline measurement The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2 Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance |
| FG001 | First Coloplast Test 2, Then Coloplast Test 1 | The subjects first test their own product to collect baseline measurements The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1 Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance Coloplast Test 2: Coloplast Test 2 is a newly developed 1-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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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | All the subjects in one group |
| 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 was measured with a 32-point scale developed by Coloplast A/S, where 0 point represents the best possible outcome (no leakage) and 32 represents the worst possible outcome (full leakage under baseplate) | Posted | Mean | Standard Deviation | units on a scale | 14 days | baseplates | Participants |
|
September - November 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 | Results from subjects testing Coloplast Test 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Redness skin | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | Coloplast A/S | +45 4911 25 23 | dkdac@coloplast.com |
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| Coloplast Test 2 | Device | Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
Data from subject testing own product. Measures baseline leakage |
|
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| 0 |
| 16 |
| 3 |
| 16 |
| EG001 | Coloplast Test 2 | Results from subjects testing Coloplast Test 2 | 0 | 18 | 1 | 18 |
| EG002 | Basline - Own Product | Data from subject testing own product. Measures baseline leakage | 0 | 18 | 0 | 18 |
| Peristomal skin irritaion | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
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