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The purpose of this study is to evaluate healthy volunteers perception of catheterization with LoFric catheters with new solvents in the manufacturing process. The subjects will be catheterized three times during one visit day.
The hypothesis is that the subjects' perception of catheterization is the same when using the test catheters compared to the reference catheter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LoFric POBE | Device | LoFric POBE, Nelaton 40 cm, CH 12 with new solvent. Each subject will use the reference catheter "LoFric POBE, Nelaton 40 cm, CH 12 with current solvent" before being catheterized with the test catheters. |
| Measure | Description | Time Frame |
|---|---|---|
| Healthy volunteers perception of catheterization | At each catheterization (three times during one day) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulf Malmqvist, MD, PhD, Assoc.Prof. | Clinical Research and Trial Centre, Lund University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research and Trial Centre, Lund University Hospital | Lund | SE-221 85 | Sweden |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 20, 2021 | |
| Reset | May 13, 2021 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 20, 2021 | May 13, 2021 |
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| LoFric POBE | Device | Unsalted LoFric POBE Hydro-Kit II, Nelaton 40 cm, CH 12 with new solvent Each subject will use the reference catheter "LoFric POBE, Nelaton 40 cm, CH 12 with current solvent" before being catheterized with the test catheters. |
|