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Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.
The 2-piece product is a part of a new product family, under the brand name SenSura. The aim of this investigation is to see how the urology product is perceived and how it performs against another 2-piece product from ConvaTec. The device 'ConvaTec 2-piece combihesive Natura' is selected as the comparative product because of its similarity to SenSura 2-piece product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SenSura | Experimental | SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate. |
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| Convatec | Active Comparator | Convatec Uro 2-piece Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convatec Uro 2-piece | Device | Specific name of the device: 'Combihesive Natura® with a Durahesive Convex-It® base plate, 45 mm coupling, moldable (13-22 and 22-33 mm) hole size with boarder tape'. The subjects are asked to test each of the two products for 21 days plus/minus 3 days in a randomised order and in accordance with their normal frequency of change and normal use pattern. The duration of the clinical investigation should be enough time to identify any difference in user-preference. If the subject is in the middle of testing an urostomy base plate when the test period is turning into the next period, the urostomy base plate can be worn until it needs to be changed. It is not possible to blind the investigation as the appearance of the test- and refer-ence products are very different in the look. |
| Measure | Description | Time Frame |
|---|---|---|
| Preference of the Two Urostomy Products | Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product. The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred. | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
In order to be enrolled in the clinical investigation, the subjects must not:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Carter, M.Sc | Coloplast A/S | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visé Mitteldeutschland GmbH | Magdeburg | 39114 | Germany |
39 subjects were enrolled in the study, however 9 subjects were excluded from participating in the study.
The subjects were recruited by the investigators at multiple sites in Germany.
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| ID | Title | Description |
|---|---|---|
| FG000 | Sensura Uro 2 Piece First, Then Convatec 2 Piece | Sensura is a newly developed two piece product for people with urostomies. |
| FG001 | ConvaTec 2 Piece,First, Then Sensura Uro 2 Piece | Convatec is the reference product and was chosen because of its similarity with the Sensura appliance. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (21 +/- 3 Days) |
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| Second Intervention (21 +/- 3 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Population | Urostomy operated 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 | Median |
| 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 | Preference of the Two Urostomy Products | Number of participants preferring the SenSura Uro 2 piece product or the reference Convatec 2 piece product. The subjects are asked via the case report form (questionnaire) at the end of the second cross over period, which of the two products they preferred. | The Per protocol (PP) population is analysed. PP-criteria: Subjects fulfill the inclusion and exclusion criteria, do not seriously violate the protocol, are exposed to both products and are evaluable with respect to the primary endpoint (state preference). *One drop out was evaluable, as the subject tried both products and stated a preference. | Posted | Number | participants | 6 weeks |
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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 Uro 2 Piece | SenSura Uro 2-piece. Is a urostomy bag with the intended use of collecting urine from a stoma. Consist of a base plate and a bag that is attached to the base plate. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ileus | Gastrointestinal disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Medical Outcome | Coloplast A/S | dkbir@coloplast.com |
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| SenSura Uro 2-piece | Device | SenSura URO 2-piece Extended Wear, convex light, 50 mm coupling, cuttable (15-33 mm) |
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| NOT COMPLETED |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG001 | Convatec 2 Piece | The reference product Convatec 2 piece is a urostomy bag intended for collecting urin from a stoma. |
|
|
| 1 |
| 30 |
| 5 |
| 30 |
| EG001 | Convatec 2 Piece | The reference product Convatec 2 piece is a urostomy bag intended for collecting urine from a stoma. | 0 | 30 | 0 | 30 |
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