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

NCT ID: NCT06632496

Last Updated: 2026-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

156 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-28

Study Completion Date

2025-09-23

Brief Summary

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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.

Detailed Description

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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

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BD Prevue II for Peripheral Intravenous Catheter Placement

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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)

BD Prevue(TM) II

Intervention Type DEVICE

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

Interventions

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BD Prevue(TM) II

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Becton, Dickinson and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Brookdale University Hospital & Medical Center

Brooklyn, New York, United States

Site Status

Allegheny Health Network Research Institute

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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MDS-23PREVUE001

Identifier Type: -

Identifier Source: org_study_id

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