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

Launched by BECTON, DICKINSON AND COMPANY · Oct 7, 2024

Keywords

ClinConnect Summary

The BD Prevue(TM) II Peripheral Vascular Access System with Cue(TM) Needle Tracking Technology Clinical Study is looking into how safe and effective this new device is for placing IV catheters, which are used to give medications and fluids to patients. This study is important because it will help gather information that can be used to ensure the device meets safety standards in different regions, including Europe.

To be eligible for this study, participants need to be at least 1 year old and suitable candidates for a specific type of IV placement procedure using this new technology. They must also be able to give consent or have someone authorized to give consent on their behalf. However, individuals who have certain allergies, skin issues, or medical histories that could complicate the procedure won't be able to participate. If you join the study, you can expect to undergo an ultrasound-guided procedure to place the IV catheter, which will be carefully monitored for safety and effectiveness.

Gender

ALL

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