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This post-market study is being conducted to generate safety and performance data on the BD Prevue(TM) II Peripheral Vascular Access System with Cue(TM) Needle Tracking Technology. The data will be utilized to support regional registrations (for example, EU MDR), and document any unforeseen residual risks.
This is an observational post-market, human subject study to evaluate the safety and performance of the BD Prevue(TM) II Peripheral Vascular Access System with Cue(TM) Needle Tracking Technology. Subjects will be recruited for participation based on need for IV catheter (midline catheters included) placement in a hospital setting.
Enrolled subjects will go through ultrasound-guided peripheral intravenous catheter (USGPIV) placement as part of their clinical care. USGPIV is defined as a procedure in which an ultrasound machine is used to assist a qualified health care provider with IV cannulation from skin puncture through venipuncture via direct visualization on the ultrasound machine in real time.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| USGPIV | Patient who is a candidate for an ultrasound-guided peripheral intravenous catheter (USGPIV) placement procedure (midline catheters included) using BD Prevue(TM) II Peripheral Vascular Access System with Cue(TM) Needle Tracking Technology as assessed per their clinician(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD Prevue(TM) II | Device | Ultrasound-guided peripheral intravenous catheter placement procedure using the BD Prevue(TM) II |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Performance: To provide visualization of the target vessel in which to insert the chosen vascular access device | The PrevueTM II system is able to visualize the target vasculature (>=70% with a 95% confidence interval) | During the procedure |
| Primary Performance: To have successful vascular access either by cannulation or blood return. | Successful access with the vascular access device, either by cannulation or blood return (>=70% with a 95% confidence interval) | During the procedure |
| Primary Performance: To determine if BD Prevue(TM) II Peripheral Vascular Access System with Cue(TM) Needle Tracking Technology is able to provide visual needle tip location tracking to assist with insertion of the chosen vascular access device. | CueTM Needle Tracking System is able to properly display the location of the needle tip during vascular access device access insertion (>=80% with a 95% confidence interval) | During the procedure |
| Primary Safety: To determine the incidence of device related adverse events, experienced by patient or user, when using the BD PrevueTM II Peripheral Vascular Access System with CueTM Needle Tracking Technology | Rate of device related adverse events (<2%). | During the procedure and 15 minutes after the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Performance: To have successful first-attempt vascular access either by cannulation or blood return when using the BD PowerGlide Pro midline catheter. | Successful first-attempt access with the PowerGlide Pro midline catheter, either by cannulation or blood return (>=70% with a 95% confidence interval) | During the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects are defined as patients who need to receive insertion of a peripheral IV (midline catheters included) catheter as part of their medical treatment
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brookdale University Hospital & Medical Center | Brooklyn | New York | 11212 | United States | ||
| Allegheny Health Network Research Institute |
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| Pittsburgh |
| Pennsylvania |
| 15212 |
| United States |