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The goal of this clinical trial is to assess the safety and efficacy of ViTal, a peripheral intravenous catheter with a glide-on-contact design of the plastic canula tip, in peripheral intravenous catheterization in individuals requiring intravenous therapy or blood sampling. The main question it aims to answer is:
What is the first attempt success rate of the peripheral intravenous catheterization done using the study device?
Participants will be asked to grade the pain they experienced when attempts were made to insert the study device into their peripheral vein.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GPIV | Experimental | If the eligibility criteria are fulfilled, up to 4 attempts will be made to achieve successful peripheral intravenous catheterization with the investigational device. All successive attempts will be made at a site different from the one(s) at which access has already failed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GPIV | Device | The investigational device is a peripheral intravenous catheter with a passive fully automatic needlestick protection, with a glide-on-contact design of the plastic cannula tip featuring asymmetry, with the negative, convex slope in the plane perpendicular to the longitudinal axis of the tip resulting in bottom part of the cannula being shorter. |
| Measure | Description | Time Frame |
|---|---|---|
| First attempt success rate | Proportion, in percent, of subjects with successful peripheral intravenous catheterization Successful PIVC is defined as withdrawal of non-pulsatile blood or infusion of saline without evidence of extravasation. Failed PIVC is defined as extravasation with initial infusion, inability to draw blood, physician or nurse intervention for access or inability to obtain access. | Periprocedural |
| Measure | Description | Time Frame |
|---|---|---|
| Device- and procedure-related adverse events | Incidence of the device- and procedure-related adverse events | Periprocedural |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Canela | La Romana | Dominican Republic |
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