Clinical trial NCT06632496: BD Prevue(TM) II Peripheral Vascular Access System With Cue(TM) Needle Tracking Technology Clinical Study
Official title: BD Prevue(TM) II Peripheral Vascular Access System With Cue(TM) Needle Tracking Technology Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: BD Prevue II for Peripheral Intravenous Catheter Placement
Lead sponsor: Becton, Dickinson and Company
Sponsor class: INDUSTRY
First posted: 2024-10-09
Enrollment: 149
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary Performance: To provide visualization of the target vessel in which to insert the chosen vascular access device
timeFrame: During the procedure
measure: Primary Performance: To have successful vascular access either by cannulation or blood return.
timeFrame: During the procedure
measure: 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.
timeFrame: During the procedure
measure: 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
timeFrame: During the procedure and 15 minutes after the procedure
Secondary outcomes:
measure: Secondary Performance: To have successful first-attempt vascular access either by cannulation or blood return when using the BD PowerGlide Pro midline catheter.
timeFrame: During the procedure
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Brookdale University Hospital & Medical Center
state: New York
Study officials:
References: