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The aim of the current clinical investigation is to evaluate the performance and safety of new 2-piece ostomy product concepts.
The new products have been developed to reduce the degree of leakage and other problems related to ostomy appliances in people with a stoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment sequence 1 | Other | Subjects randomised to Treatment sequence 1 will test three different products:
The subjects test the three test products in a randomized order: ABS; BSA, SAB |
|
| Treatment sequence 2 | Experimental | Subjects randomised to Treatment sequence 2 will test three different products:
The subjects test the three test products in a randomized order: CBS; BSC, SCB |
|
| Treatment sequence 3 | Experimental | Subjects randomised to Treatment sequence 3 will test three different products:
The subjects test the three test products in a randomized order: ACS; CSA, SAC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coloplast A | Device | Coloplast A is a newly developed 2-piece ostomy appliance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Degree of Leakage | The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S. The 4-point leakage scale has four choices
Leakage was assessed at every baseplate change | 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Carter, MSc | Coloplast A/S | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coloplast A/S | Humlebæk | 3050 | Denmark |
Thirty-one subjects signed the informed consent, but 2 subjects were screen failures and did not test any products. These two subjects are not included in the participant flow below.
The subject were recruited through the Coloplast user data base.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test A/ Test B/ SenSura | The subjects first tested Coloplast test product A then Cololpast test product B and finally the comparator SenSura |
| FG001 | Test A/ Test C/ SenSura | The subjects first tested Coloplast test product A then Cololpast test product C and finally the comparator SenSura |
| FG002 | Test B/ SenSura/ Test A | The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product A |
| FG003 | Test B/ SenSura/ Test C | The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product C |
| FG004 | Test C/ Test B/ SenSura | The subjects first tested Coloplast test product C then Cololpast test product B and finally the comparator SenSura |
| FG005 | Test C/ SenSura/ Test A | The subjects first tested Coloplast test product C then the comparator SenSura and finally Cololpast test product A |
| FG006 | SenSura/Test A/Test B | The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product B |
| FG007 | SenSura/Test A/Test C | The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product C |
| FG008 | SenSura/Test C/Test B | The subjects first tested the comparator product SenSura then Coloplast test product C and finally Cololpast test product B |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Test Period 1 |
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| Test Period 2 |
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| Test Period 3 |
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Only includes the ITT population. The two screen failures and the subject who did not complete the Test B period as planned are not included.
The subject that did not complete the test B period was also a screen failure, however it was first discovered after applying a product. Thus, no endpoint data has been recorded for this subject.
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | baseline data is given for subjects in the ITT 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 | Degree of Leakage | The degree of leakage is assessed using a 4 point leakage scale developed by Coloplast A/S. The 4-point leakage scale has four choices
Leakage was assessed at every baseplate change | Posted | Mean | Standard Deviation | units on a scale | 10 days | baseplates | Participants |
|
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The safety population included all subjects who had signed the informed consent form and had applied at least one product. Thus, 29 subjects were included in the safety population, which included the subjects who anly tested Test B very shortly.
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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 A | Coloplast Test product A is a new test product |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| stenosis of catherter in the right kidney | Renal and urinary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| peristomal skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marian Sinvani | Coloplast A/S | +45 4911 2356 | dkmards@coloplast.com |
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| Coloplast B | Device | Coloplast B is a newly developed 2-piece ostomy appliance |
|
| Coloplast C | Device | Coloplast C is a newly developed 2-piece ostomy appliance |
|
| SenSura Click | Device | The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S. |
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| COMPLETED |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
new test product |
| OG003 | SenSura | The comparator |
|
|
| 0 |
| 19 |
| 6 |
| 19 |
| EG001 | Coloplast Test Product B | Coloplast Test product B is a new test product | 0 | 19 | 8 | 19 |
| EG002 | Coloplast Test Product C | Coloplast Test product C is a new test product | 0 | 19 | 4 | 19 |
| EG003 | SenSura | The comparator was the CE-marked product SenSura Click | 1 | 28 | 6 | 28 |
| stinging skin by fistel | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| cramps in the right kidney with sever pain | Renal and urinary disorders | Non-systematic Assessment | not related to the product |
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| influenza | Infections and infestations | Non-systematic Assessment |
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| cold | Infections and infestations | Non-systematic Assessment |
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| back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| bladder infection | Renal and urinary disorders | Non-systematic Assessment |
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| peristomal skin irritaion | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| diarre due to food intolerance | Gastrointestinal disorders | Non-systematic Assessment |
|
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