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The aim of the investigation was to investigate the performance and safety of a new ostomy product
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Coloplast Test | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Coloplast Test; Secondly to either
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| First Competitor soft convex | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Competitor soft convex; Secondly to either
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| First Own product | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of the treatments to the periods. First subjects are allocated to Own product; Secondly to either
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Test | Device | Newly developed 1-piece convex ostomy product |
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| Measure | Description | Time Frame |
|---|---|---|
| Degree of Leakage | The degree of leakage is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage. | 14 +/- 3 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 |
|---|---|---|---|---|---|---|
| TFS | Søborg | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Test - Competitor - Own | The subjects were randomized into six possible treatment groups: The order of test products for this group was: Coloplast test product Competitor soft convex product Own product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject's own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product |
| FG001 | Competitor - Own - Test | The subjects were randomized into six possible treatment groups: The order of test products for this group was: Competitor soft convex product Own product Coloplast test product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product |
| FG002 | Own - Test - Competitor | The subjects were randomized into six possible treatment groups: The order of test products for this group was: Own product Coloplast test product Competitor soft convex product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product |
| FG003 | Competitor - Test - Own | The subjects were randomized into six possible treatment groups: The order of test products for this group was: Competitor soft convex product Coloplast test product Own product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product |
| FG004 | Own - Competitor - Test | The subjects were randomized into six possible treatment groups: The order of test products for this group was: Own product Competitor soft convex product Coloplast test product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product |
| FG005 | Test - Own - Competitor | The subjects were randomized into six possible treatment groups: The order of test products for this group was: Coloplast test product Own product Competitor soft convex product Coloplast Test: Newly developed 1-piece convex ostomy product Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more. Competitor soft convex: A commercially available soft convex product |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
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| Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Pooled data from all arms. |
| 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 is investigated on a 32-point scale (including 0 for no leakage). O represents no leakage and 32 represents the worst leakage. | Posted | Mean | Standard Deviation | units on a scale | 14 +/- 3 days | Baseplates | Participants |
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The AE were reported throughout the investigation, up to 5 months.
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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 Product | Adverse events reported by subjects testing Coloplast test product |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystitis | Renal and urinary disorders | Systematic Assessment | Unlikely related to the product |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peristomal skin irritation/ broken skin/ stomal bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment | Definitely, probably or possibly related to the product |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Coloplast A/S | +45 4911 1395 | dkbir@coloplast.com |
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| Own product | Device | The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more. |
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| Competitor soft convex | Device | A commercially available soft convex product |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 1 |
| 37 |
| 22 |
| 37 |
| EG001 | Own Product | Adverse events reported by subjects testing own product | 1 | 38 | 12 | 38 |
| EG002 | Competitor Soft Convex | Adverse events reported by subjects testing Competitor soft convex | 0 | 37 | 23 | 37 |
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| Influenza/ cold/ sore throat, Pneumonia, vomiting, infected wounds | Infections and infestations | Systematic Assessment | all AEs except one were unlikely or not related to the product. One AE (wound due to lower corner at hideaway scratching against leg) was definitely related to the product. |
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| control of fistula, pain after control of fistula, constipation, sub ileus | Gastrointestinal disorders | Systematic Assessment | unlikely or not related to the product |
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| headache, pain in right hand | Nervous system disorders | Systematic Assessment | unlikely and not related to product |
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| Herpes Zoster | Immune system disorders | Systematic Assessment | not related to product |
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| Cataract | Surgical and medical procedures | Systematic Assessment | unlikely related to product |
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| Gash on the riight Tibia (tipped on bike) | Social circumstances | Systematic Assessment | not related to product |
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| Skin and subcutaneous tissue disorders | Systematic Assessment | Its written in the AE description: drainage is something mess, due to missing flap which is on the coloplast product. |
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