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

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.

Study Overview

• Status: Completed
• Conditions: BD Prevue II for Peripheral Intravenous Catheter Placement
• Intervention / Treatment: Device: BD Prevue(TM) II

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.

• Study Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11212
      • Brookdale University Hospital & Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny Health Network Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Subjects are defined as patients who need to receive insertion of a peripheral IV (midline catheters included) catheter as part of their medical treatment

Description

Inclusion Criteria:

• Age 1 years, or older
• A patient who is a candidate for an ultrasound-guided peripheral intravenous catheter (midline catheters included) placement procedure using BD PrevueTM II Peripheral Vascular Access System with CueTM Needle Tracking Technology as assessed per their clinician(s)
• Able and willing to provide informed consent or legal authorized representative (LAR) authorized to give consent on behalf of the subject

Exclusion Criteria:

• Any patient in whom ultrasound procedure might interfere with medical care or create undue hardship
• Known, or suspected, allergy to materials contained in the BD PrevueTM II Peripheral Vascular Access System with CueTM Needle Tracking Technology or accessories that may come in contact with the patient
• Localized skin, tissue, or other clinical factors that would prevent completion of the ultrasound procedure
• Previous medical history that would prevent completion of the ultrasound procedure

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Device: BD Prevue(TM) II; Ultrasound-guided peripheral intravenous catheter placement procedure using the BD Prevue(TM) II

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Becton, Dickinson and Company

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2025
• Primary Completion (Actual): September 23, 2025
• Study Completion (Actual): September 23, 2025

Study Registration Dates

• First Submitted: October 7, 2024
• First Submitted That Met QC Criteria: October 7, 2024
• First Posted (Actual): October 9, 2024

Study Record Updates

• Last Update Posted (Estimated): January 16, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MDS-23PREVUE001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No