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The aim of the current investigation is to evaluate the combination of an adhesive with a soft top film.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Test product; then SenSura | Experimental | The subject in this arm first test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details. After cross-over the subject test SenSura which is CE-marked and commerical available. |
|
| First SenSura, Then Test product | Active Comparator | The subject in this arm first test SenSura which is CE-marked and commerical available. After cross-over the subject test the Test product The test product is a newly developed ostomy appliance with a new top film. Due to company confidentiality the product is not described in further details. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Test product | Device | The test product consists of an adhesive with a new top film |
|
| Measure | Description | Time Frame |
|---|---|---|
| Leakage (Percentage of All Baseplates With Leakage) | leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate. The subjects tick of one of the four possible answers:
| After each baseplate change over a period, of 7 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 |
|---|---|---|---|---|---|---|
| Skövde Hospital | Skövde | 541 85 | Sweden |
The investigation was designed as a cross-over study where subjects that did not complete the 1 period as planned were allowed to continue to the next test period.
The subjects were recruited from hospital sites in Sweden and in Germany subjects were recruit from the Coloplast database and from hospital sites.
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| ID | Title | Description |
|---|---|---|
| FG000 | First Test Product; Then SenSura | The subjects tested two products: In the first period the subjects tested the newly developed ostomy bag called Test product. In the second period the subjects tested the comparator SenSura |
| FG001 | First SenSura, Then Test Product | The subjects tested two products: In the first period the subjects tested the comparator SenSura. In the second period the subjects tested the newly developed ostomy bag called Test product |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (7 Days) |
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| Period 2 (7 Days) |
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Three subjects were excluded from the intention to treat (ITT) population. Two of the were inclusion criteria violaters; 1 convex user and 1 colostomist. with the last subject it was uncertain in which order the subject tested the test products. the subejct was excluded from the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study | Describing baseline data for all 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 | Leakage (Percentage of All Baseplates With Leakage) | leakage is measured using a 4-point leakage scale developed by Coloplast A/S. At every baseplate change the subjects had to look at the skin facing side of the baseplate and access which of the four scenarios described below provided an accurate description of the baseplate. The subjects tick of one of the four possible answers:
| Posted | Number | percentage baseplates with leakage | After each baseplate change over a period, of 7 days | Baseplates | Participants |
|
The adverse events were collected for 14 days
The subject for whom it was unknown which intervention was recieved did not have any adverse events in the course of the study
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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 Product | The new test product is a 1-piece open ostomy product with the intended use being collecting output from an ileostomy. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pain in the peristomal area | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Camilla Felsvang Vibjerg, Senior Clinical manager | Coloplast A/S | +45 4911 1990 | dkcfv@coloplast.com |
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| SenSura | Device | SenSura is the CE-marked and commercially available comparator product |
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| Protocol Violation |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | SenSura | CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy. |
|
|
| 0 |
| 32 |
| 1 |
| 32 |
| EG001 | SenSura | CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy. | 0 | 32 | 1 | 32 |
| Itching in the peristomal area | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| red skin in the peristomal area | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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