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

NCT06632496 | Completed

• 1 other identifier: MDS-23PREVUE001
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

BD Prevue II for Peripheral Intravenous Catheter Placement

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Secondary Performance: To have successful first-attempt vascular access either by cannulation or blood return when using the BD PowerGlide Pro midline catheter.

  During the procedure

Study Arms (1)

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

Interventions

BD Prevue(TM) II DEVICE

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

USGPIV

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (2)

Brookdale University Hospital & Medical Center

Brooklyn, New York, 11212, United States

Location

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania, 15212, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2024
• First Posted: October 9, 2024
• Study Start: March 28, 2025
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)