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To assess the functionality and safety of the test products and also assess the products' ability to collect stool without interfering with the stoma. The degree of leakage using the product will also be measured
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1; First Coloplast Test product 1 | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Coloplast Test product 1 are randomised to secondly test either:
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| Treatment 2; First Coloplast Test product 2. | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Coloplast Test product 2 are randomised to secondly test either:
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| Treatment 3,First Standard care (see below) | Experimental | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Standard Care Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) are randomised to secondly test either:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast Test product 1 | Device | Coloplast Test product 1 is a new ostomy appliance developed by Coloplast. |
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| Measure | Description | Time Frame |
|---|---|---|
| Degree of Leakage | The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S | Up to 14 days per test product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birte Petersen | Coloplast A/S | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | Denmark |
25 subjects signed informed consent and were randomized. 2 subjects were screening failures and did not test any products. One subject violated an inclusion criterion (convex user). The subject tested both test products and is therefore included in the safety population.
The 3 subjects are not included in the participant flow below.
The subjects were recruited through the Coloplast database in Denmark
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| ID | Title | Description |
|---|---|---|
| FG000 | First Test Product 1, Then Test Product 2;Then Standard Care | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Coloplast Test product 1 are randomised to secondly test : - Coloplast Test product 2 and thereafter - Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Test Period 1 (14 Days) |
|
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| Coloplast Test product 2 | Device | Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S |
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| Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) | Device | Standard Care was the subject usual ostomy appliance and had to be one of the following:
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| FG001 | First Test Product 1, Then Standard Care, Then Test Product 2 | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Coloplast Test product 1 are randomised to secondly test : 1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) and thereafter 1) Coloplast Test product 2 |
| FG002 | First Test Product 2, Then Test Product 1, Then Standard Care | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Coloplast Test product 2 are randomised to secondly test 1) Coloplast Test product 1 and thereafter 1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) |
| FG003 | First Test Product 2; Then Standard Care, Then Test Product 1 | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Coloplast Test product 2 are randomised to secondly test : 1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active) and thereafter 1) Coloplast Test product 1 |
| FG004 | First Standard Care, Then Test Product 1, Then Test Product 2 | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test 1) Coloplast Test product 1 and thereafter 1) Coloplast Test product 2 |
| FG005 | First Standard Care, Then Test Product 2, Then Test Product 1 | The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods. Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test 1) Coloplast Test product 2 and thereafter 1) Coloplast Test product 1 |
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| Test Period 2 (14 Days) |
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| Test Period 3 (14 Days) |
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Two subjects were screening failiures and did not test any test product, but did contribute with baseline data. These subjects are not inclæuded in the participant flow (as the did not test products) but contributed with baseline data.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects |
| 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 |
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| Sex: Female, Male | 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 | Degree of Leakage | The degree of leakage was measured on a 24-point scale 0 (best possible outcome) to 24 (worst possible outcome) developed by Coloplast A/S | Posted | Mean | Standard Deviation | units on a scale | Up to 14 days per test product | baseplates | Participants |
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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 1 | data from all subjects who tested Test 1 baseplates | 1 | 22 | 5 | 22 | ||
| EG001 | Coloplast Test Product 2 | data from all subjects who tested Test 2 baseplates | 0 | 22 | 6 | 22 | ||
| EG002 | Standard Care | data from all subjects who tested Standard Care baseplates | 0 | 22 | 3 | 22 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenterit | Gastrointestinal disorders | Systematic Assessment | Not related to the test product |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Peristomal skin problem | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Related to the test products |
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| Bleeding from stoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Related to the test products |
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| respirational tract infection | Infections and infestations | Systematic Assessment | Not related to the test products |
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| infection of the operational wound on the back/ haemtom in operational wound | Infections and infestations | Systematic Assessment | not related to the test products |
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| Diarre | Gastrointestinal disorders | Systematic Assessment | not related to the test products |
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| inflammation in rectum | Gastrointestinal disorders | Systematic Assessment | not related to the test products |
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| Pain in collapsed forefoot | General disorders | Systematic Assessment | Not relate to the test products |
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| Gastroenterit | Gastrointestinal disorders | Systematic Assessment | Not related to the test products |
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| short term dizziness | General disorders | Systematic Assessment | Not related to test product |
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| stinging skin around the stoma | Skin and subcutaneous tissue disorders | Non-systematic Assessment | not related to the test products |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marian Dyreborg Sinvani, Clinical Manager | Coloplast A/S | +45 4911 2356 | dkmards@coloplast.com |