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The aim of the current clinical investigation is to evaluate a new filter
The filter has been developed in order to significantly reduce problems with ballooning and other problems related to filter performance in people with a stoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sensura | Active Comparator | SenSura is the reference product and the product is already commercially available |
|
| Morfeus | Experimental | The test product is the product with the proposed new filter (Morfeus) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SenSura | Device | The ostomy bag filter will be tested for a period of 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period. | Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period. | Daily or at every change of bag in a period of a maximum of 28 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 |
20 subjects were enrolled and randomized in the study.
The subjects were recruited from a user data base in Denmark.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sensura First; Then Morfeus | The reference product is the SenSura product which is already commercially available |
| FG001 | Morfeus First; Then Sensura | The test product with the Morfeus filter is the test product with the proposed new filter. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (14 Days) |
| |||||||||||||
| Period 2 (14 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sensura | The reference product is the SenSura product which is already commercially available |
| BG001 | Morfeus | The test product is the product with the proposed new filter (Morfeus) |
| 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 | Frequency of Ballooning in the Morfeus and the Sensura Filter Test Period. | Data will not be recorded at specific time points due to individual changing patterns (1-2 bags per day). Study subjects will fill out the Case Report Form (CRF) by themselves when changing bag. The subject is asked in the CRF among others the reason for changing bag (e.g. ballooning). Subjects will change bag according to their normal routine or when deemed appropriate. They are advised to change bag if it is filled with air and the air cannot be released through the filter within a specified time period. | Intention to treat (ITT) | Posted | Number | percentage bags with ballooning | Daily or at every change of bag in a period of a maximum of 28 days | Bags | 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 | Sensura | The reference product is the SenSura product which is already commercially available |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abscess in the buttock | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pristomal skin redness | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Medical Affairs | Coloplast A/S | 4549111111 | dkbir@coloplast.com |
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| Morfeus |
| Device |
The new ostomy bag filter will be tested for a period of 14 days |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Morfeus | The test product is the product with the proposed new filter (Morfeus) |
|
|
| 1 |
| 20 |
| 3 |
| 20 |
| EG001 | Morfeus | The test product is the product with the proposed new filter (Morfeus) | 0 | 20 | 0 | 20 |
| Sleep disruption | Nervous system disorders | Non-systematic Assessment |
|
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