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The aim of the current clinical investigation is to evaluate a new filter.
The new 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 | The reference product is the CE marked and launched SenSura product which is commercially available |
|
| Morfeus | Experimental | The test product is the product with the proposed new Morfeus filter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Morfeus | Device | The new ostomy bag filter (called Morfeus) will be tested for a period of 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Ballooning in the Morfeus and SenSura Test Period. | Data will not be recorded at specific time points due to individual changing patterns (1-3 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
Subjects were recruited from a user database in Denmark
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| ID | Title | Description |
|---|---|---|
| FG000 | Morfeus First (Test Filter), Then SenSura (Reference Filter) | First Intervention with Morfeus (14 days) then Second Intervention with SenSura (14 days) |
| FG001 | SenSura First (Reference Filter), Then Morfeus (Test Filter) | First Intervention with SenSura (14 days) then Second Intervention with Morfeus (14 days) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (14 Days) |
| |||||||||||||
| Second Intervention (14 Days) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Morfeus (Test Filter) | The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance. |
| BG001 | SenSura (Reference Filter) | The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag. |
| 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 SenSura Test Period. | Data will not be recorded at specific time points due to individual changing patterns (1-3 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. | ITT | Posted | Number | percentage of bags | 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 | Morfeus (Test Filter) | The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin redness and puritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Medical Affairs | Coloplast A/S | 4549111111 | dkbir@coloplast.com |
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| SenSura | Device | The CE marked ostomy bag filter will be tested for a period of 14 days |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| OG001 | SenSura (Reference Filter) | The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag. |
|
|
| 0 |
| 20 |
| 2 |
| 20 |
| EG001 | SenSura (Reference Filter) | The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag. | 0 | 20 | 4 | 20 |
| Diarrhoea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Cold | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
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