BD Prevue(TM) II
DeviceUltrasound-guided peripheral intravenous catheter placement procedure using the BD Prevue(TM) II
NCT Number: NCT06632496
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.
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All sexes
Observational
Brookdale University Hospital & Medical Center, Brooklyn, New York, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Ultrasound-guided peripheral intravenous catheter placement procedure using the BD Prevue(TM) II
Time frame: During the procedure
The PrevueTM II system is able to visualize the target vasculature (>=70% with a 95% confidence interval)
Time frame: During the procedure
Successful access with the vascular access device, either by cannulation or blood return (>=70% with a 95% confidence interval)
Time frame: During the procedure
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)
Time frame: During the procedure and 15 minutes after the procedure
Rate of device related adverse events (<2%).
Time frame: During the procedure
Successful first-attempt access with the PowerGlide Pro midline catheter, either by cannulation or blood return (>=70% with a 95% confidence interval)
Becton, Dickinson and Company
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.