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This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test A, Test B, Subjects own product | Experimental | The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product |
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| Test A, Subjects own product, Test B | Experimental | The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B |
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| Test B, Test A, Subjects own product | Experimental | The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product |
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| Test B, Subjects own product, Test A | Experimental | The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A |
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| Subjects own product, Test A, Test B | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Test A | Device | Test A is a new 1-piece ostomy appliance developed by Coloplast A/S |
|
| Measure | Description | Time Frame |
|---|---|---|
| Fit to Body | Subjects will evaluate the fit to body for each product by answering the question "how was the baseplates ability to fit the body contours in the area around the stoma?" The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question. | 14 +/- 2 days |
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Inclusion Criteria:
1. Have given written informed consent and in DK: signed a letter of authority 2. Are at least 18 years of age and have full legal capacity 3. Have had their ileostomy or colostomy for at least 3 months 4. Are able to use a baseplate cut-max 15 to 40 mm 5. Are able to handle the product themselves 6. Currently using a 1-piece flat product 8. Willing to use an open bag size maxi during the investigation 9. Are able to use a custom cut (custom fit) product 10. Are suitable for participating in the investigation - this means that the subjects must be able to follow all elements of the study procedures.
Exclusion Criteria:
Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
Are pregnant or breastfeeding**
Are participating in other interventional clinical investigations or have previously participated in this investigation
Use irrigation during the investigation (flush the intestines with water, this is mostly for people with a colostomy)
Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
Have a loop ostomy (also called double barrel ostomy)
Have known hypersensitivity towards any of the products used in the investigation
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| Name | Affiliation | Role |
|---|---|---|
| Camilla F Vibjerg | Head of Clinical Operation | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiant Research | Tempe | Arizona | 85282 | United States | ||
| Prism research center |
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The subjects were recruited through the Coloplast A/S database and from hospital sites
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| ID | Title | Description |
|---|---|---|
| FG000 | Test A, Test B, Subjects Own Product | The subjects first test Coloplast Test A, followed by Coloplast Test B and finally Subjects own product Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Test Period 1 |
|
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The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B
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| Subjects own product, Test B, Test A | Experimental | The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A |
|
| Coloplast Test B | Device | Test B is a new 1-piece ostomy appliance developed by Coloplast A/S |
|
| Subjects own product | Device | The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group. |
|
| Saint Paul |
| Minnesota |
| 55114 |
| United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| TFS | Søborg | 2860 | Denmark |
| QPS Netherlands | Groningen | 9713 | Netherlands |
| Synexus Midlands | Birmingham | B15 2SQ | United Kingdom |
| Pilgrim Hospital | Boston | United Kingdom |
| Illingworth Research Nurses | Cheshire | Sk11 6TG | United Kingdom |
| Lincon Country hospital | Lincoln | LN25QY | United Kingdom |
| Aintree University Hospital NHS Foundation Trust | Liverpool | l9 7AL | United Kingdom |
| Kettering General hospital | Northamptonshire | NN168UZ | United Kingdom |
| Synexus Hexam | Northumberland | NE46 1QJ | United Kingdom |
| FG001 | Test A, Subjects Own Product, Test B | The subjects first test Coloplast Test A, followed by Subjects own product, and finally Coloplast Test B Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group. |
| FG002 | Test B, Test A, Subjects Own Product | The subjects first test Coloplast Test B, followed by Coloplast Test A and finally Subjects own product Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group. |
| FG003 | Test B, Subjects Own Product, Test A | The subjects first test Coloplast Test B, followed by Subjects own product, and finally Coloplast Test A Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group. |
| FG004 | Subjects Own Product, Test A, Test B | The subjects first test Subjects own product, followed by Test A, and finally Coloplast Test B Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group. |
| FG005 | Subjects Own Product, Test B, Test A | The subjects first test Subjects own product, followed by Test B, and finally Coloplast Test A Coloplast Test A: Test A is a new 1-piece ostomy appliance developed by Coloplast A/S Coloplast Test B: Test B is a new 1-piece ostomy appliance developed by Coloplast A/S Subjects own product: The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group. |
| COMPLETED |
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| NOT COMPLETED |
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| Test Period 2 |
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| Test Period 3 |
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The baseline population consist of all enrolled subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | The Study Population | This consists of all participants who were enrolled in the study |
| 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 | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | One subject did not aswer the gender question therefore this information is missing. | Count of Participants | Participants |
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| 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 | Fit to Body | Subjects will evaluate the fit to body for each product by answering the question "how was the baseplates ability to fit the body contours in the area around the stoma?" The question is answered using an ordinal 5 point scale ranging from very poor to very good. The result shown below shows the fraction of subject who answered 'Good' or' Very Good' to the question. | Posted | Number | percentage of good or very good | 14 +/- 2 days |
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Adverse events were collected from subject enrollment to the subject left the study. Subjects with serious adverse events were followed until their condition was resolved.
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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 A | This is the result from all subjects evaluating Test A | 1 | 52 | 8 | 52 | ||
| EG001 | Test B | This is the results from all the subjects evaluating Test B | 0 | 54 | 11 | 54 | ||
| EG002 | Own Product | this is the result from all the subjects evaluating Own product. | 0 | 51 | 4 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Obstibation | Gastrointestinal disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peristomal skin dermatitis | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Gosk | Scientific and Regulatory affairs | +45 49113568 | dksargo@coloplast.com |
| Adverse Event |
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| Male |
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