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The primary objective of the investigation is to explore the acceptance of a newly developed adhesive.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baseline - Test A - Test B | Experimental | Three period investigation. First each subject tests baseline product, then Test A and finally Test B. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces |
|
| Baseline - Test B - Test A | Experimental | First each subject tests baseline product, then Test B and finally Test A. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test A | Device | Ostomy appliance |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Product Acceptance | Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products. There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate. The result presented below shows how many subjects preferred Test A/Test B over own product | 7 days per test period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birte Petersen 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 | Baseline - Test A - Test B | First each subject tests baseline product, then Test A and finally Test B. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces |
| FG001 | Baseline - Test B - Test A | First each subject tests baseline product, then Test B and finally Test A. Baseline product: the subject's usual product Test A: A newly developed 1-piece, open ostomy appliance for collecting feces Test B: A newly developed 1-piece, open ostomy appliance for collecting feces |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Period |
| |||||||||||||
| Period 1 |
| |||||||||||||
| Period 2 |
|
Ileostomy opereated subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | The investigation is a cross-over investigation therefore baseline data is presented for the overall 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 | Product Acceptance | Product acceptance was measurement qualitatively by interviews exploring the factors and mechanisms affecting the acceptance. The interview questions were formulated in such a way that was not possible to quantify the number of subjects accepting the test products. There were problems with test product performance and handling and therefore the acceptance of the products was not high. Product preference was secondary endpoint, where the subjects were asked whether they preffered their own product over the test products. This endpoint is the best measure we have for mimiking product acceptance. However, we are aware subjects could accept a product without preferring it over own product and the preferrence result might therefore not be accurate. The result presented below shows how many subjects preferred Test A/Test B over own product | One subject did not answer the preference question. | Posted | Number | participants | 7 days per test period |
|
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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 | Baseline | Adverse events reported by subjects testing Own product |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Common Cold with fever | Infections and infestations | Systematic Assessment | not related to device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Coloplast A/S | +45 4911 1395 | dkbir@coloplast.com |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Test B |
| Device |
Ostomy appliance |
|
| Baseline | Device | Ostomy appliance |
|
| NOT COMPLETED |
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| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
How many subjects preferred Test A over own product |
| OG001 | Test B | How many subjects preferred Test B over own product |
|
|
| 0 |
| 10 |
| 1 |
| 10 |
| EG001 | Test A | Adverse events reported by subjects testing Test A | 0 | 10 | 3 | 10 |
| EG002 | Test B | Adverse events reported by subjects testing Test B | 0 | 10 | 2 | 10 |
|
| Peristomal skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pain from peristomal skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment | not related to device |
|
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |