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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A01774-43-A | Other Identifier | French Health Autority |
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The clinical study evaluates the safety of a new catheter for Urinary Intermittent Catheterisation in self catheterized patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Actreen Hydrolite Cath | Experimental | a new hydrophilic coated catheter for Urinary Intermittent Catheterisation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Actreen Hydrolite Cath | Device | Depending of the use of the self catheterized patient could be 4 to 6 Actreen Hydrolite Cath per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Hydrolite Cath will be demonstrated by listing any adverse event(s) related to the use of Actreen® Hydrolite Cath and other occurrence | All adverse event(s) occured during the 7 (±1) days, related to the use of Actreen Hydrolite Cath, will be registered. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chartier-Kastler Emmanuel | Hôspital Raymond Poincaré - Garches | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chartier-Kastler | Garches | 92380 | France |
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