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This post-market study is being conducted to generate safety and performance data on the SiteRite 9 System. The data will be utilized to support regional registrations (for example, EU MDR), and document any unforeseen residual risks.
This is an observational post-market, human subject study to evaluate the safety and performance of the SiteRite 9 System. Subjects will be recruited for participation based on need for Vascular Access Device (VAD) placement in a hospital setting.
Enrolled subjects will go through ultrasound-guided Vascular Access Device (USGVAD) placement as part of their clinical care. USGVAD 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| USGVAD | Patient who is a candidate for an ultrasound-guided vascular access device (USGVAD) placement procedure using SiteRite 9 System as assessed per their clinician(s) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BD SiteRite(TM) 9 | Device | Ultrasound-guided vascular access device placement procedure using the BD SiteRite(TM) 9. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Performance: To provide visualization of the target vessel in which to insert the chosen vascular access device. | The BD SiteRiteTM 9 Ultrasound 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 Safety: To determine the incidence of device related adverse events, experienced by patient or user, when using the BD SiteRiteTM 9 Ultrasound System. | Rate of device related adverse events (<2%). | During the procedure and 15 minutes after the procedure |
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Inclusion Criteria
Exclusion Criteria:
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Subjects are defined as patients who need to receive insertion of a vascular access devices (VAD) as part of their medical treatment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brookdale University Hospital & Medical Center | Brooklyn | New York | 11212 | United States |
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