NCT06632496

BD Prevue(TM) II Peripheral Vascular Access System With Cue(TM) Needle Tracking Technology Clinical Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 156 (actual)
• Sponsor: Becton, Dickinson and Company · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• BD Prevue II for Peripheral Intravenous Catheter Placement

Interventions

Type	Name	Description
DEVICE	BD Prevue(TM) II	Ultrasound-guided peripheral intravenous catheter placement procedure using the BD Prevue(TM) II

Timeline

• Start date: 2025-03-28
• Primary completion: 2025-09-23
• Completion: 2025-09-23
• First posted: 2024-10-09
• Last updated: 2026-01-16

Locations

2 sites across 1 country: United States