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| ID | Type | Description | Link |
|---|---|---|---|
| CP235 | Other Identifier | Coloplast |
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The aim of the study is to evaluate safety and performance of a new catheter coating,compared to the current SpeediCath coating.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Active Comparator | SpeediCath catheter then ZN-D catheter then ZN-C catheter |
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| Sequence 2 | Experimental | SpeediCath catheter then ZN-C catheter then ZN-D catheter |
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| Sequence 3 | Experimental | ZN-D catheter then SpeediCath catheter then ZN-C catheter |
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| Sequence 4 | Experimental | ZN-D catheter then ZN-C catheter then SpeediCath catheter |
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| Sequence 5 | Experimental | ZN-C catheter then SpeediCath catheter then ZN-D catheter |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZN-D catheter | Device | ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Discomfort During Catheterization | Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Bagi, MD, PhD | Department of Urology, Rigshospitalet Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology | Copenhagen | 2100 | Denmark |
40 subjects were included in the safety population. 4 subjects discontinued because they were unable to catheterize with given catheter. these drop-outs were distributed evenly among the catheter types:
1 subjects: SC
These subjects were excluded from the ITT population as no endpoints were registered for them
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| ID | Title | Description |
|---|---|---|
| FG000 | SpeediCath Catheter Then ZN-D Catheter Then ZN-C Catheter | First SpeediCath catheter then ZN-D catheter then ZN-C catheter |
| FG001 | SpeediCath Catheter Then ZN-C Catheter Then ZN-D Catheter | First SpeediCath catheter then ZN-C catheter then ZN-D catheter |
| FG002 | ZN-D Catheter Then SpeediCath Catheter Then ZN-C Catheter | First ZN-D catheter then SpeediCath catheter then ZN-C catheter |
| FG003 | ZN-D Catheter Then ZN-C Catheter Then SpeediCath Catheter | First ZN-D catheter then ZN-C catheter then SpeediCath catheter |
| FG004 | ZN-C Catheter Then SpeediCath Catheter Then ZN-D Catheter | First ZN-C catheter then SpeediCath catheter then ZN-D catheter |
| FG005 | ZN-C Catheter Then ZN-D Catheter Then SpeediCath Catheter | First ZN-C catheter then ZN-D catheter then SpeediCath catheter |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Test Period |
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| Second Test Period |
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| Third Test Period |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | The intention to treat population consists of 36 healthy male 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 | 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 | Overall Discomfort During Catheterization | Evaluated by the subject on a 10 cm Visual Analog Scale (VAS), where 0 cm is no discomfort and 10 cm is the worst possible discomfort. | Posted | Mean | Standard Deviation | cm | 1 day |
|
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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 | All Participants | Data from subjects in the safety population. Definition of safety population: subjects that have given informed consent and have been exposed to at least one product. However for 4 of these subjects no endpoint data was obtained and they were not included in the ITT population; they therefore do not appear in the participant flow module. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trine Møller Senior Clinical Manager | Coloplast A/S | +45 4911 2174 | dktrm@coloplast.com |
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| Sequence 6 | Experimental | ZN-C catheter then ZN-D catheter then SpeediCath catheter |
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| ZN-C catheter | Device | ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating. |
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| SpeediCath catheter | Device | The Speedicath cathere is CE-marked and commercially available. |
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| COMPLETED |
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| NOT COMPLETED |
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| COMPLETED |
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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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| 0 |
| 40 |
| 0 |
| 40 |
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