Evaluating a new system for placing IV catheters
BD Prevue(TM) II Peripheral Vascular Access System With Cue(TM) Needle Tracking Technology Clinical Study
This study is testing a new system for placing IV catheters using ultrasound to see if it makes the process safer and more effective for patients who need it in the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 149 (estimated) |
| Ages | 1 Year and up |
| Sex | All |
| Sponsor | Becton, Dickinson and Company Industry-sponsored |
| Locations | 1 site (Brooklyn, New York) |
| Trial ID | NCT06632496 on ClinicalTrials.gov |
What this trial studies
This observational study aims to gather safety and performance data on the BD Prevue II Peripheral Vascular Access System with Cue Needle Tracking Technology. Participants will be recruited based on their need for ultrasound-guided peripheral intravenous catheter placement in a hospital setting. The study will involve real-time ultrasound assistance during the IV cannulation procedure, allowing for better visualization and potentially improved outcomes. The data collected will support regional registrations and assess any unforeseen risks associated with the device.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 1 year or older who require ultrasound-guided peripheral intravenous catheter placement.
Not a fit: Patients who have allergies to the materials in the BD Prevue II system or those with conditions that would interfere with the ultrasound procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of IV catheter placements for patients.
How similar studies have performed: Other studies have shown promise in using ultrasound guidance for IV placements, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Brooklyn, New York
- Brookdale University Hospital & Medical Center — Brooklyn, New York, United States (Recruiting)
Study contacts
- Study coordinator: Edith Simard
- Email: edith_simard@bd.com
- Phone: 418-576-7356
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.