BD SiteRite 9 for VAD Insertion
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEBD SiteRite(TM) 9
Ultrasound-guided vascular access device placement procedure using the BD SiteRite(TM) 9.
Sponsors
Becton, Dickinson and Company
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 1 years, or older * A patient who is a candidate for an ultrasound-guided VAD placement procedure using SiteRite 9 System 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 SiteRite 9 System 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Performance: To provide visualization of the target vessel in which to insert the chosen vascular access device. | During the procedure | The BD SiteRiteTM 9 Ultrasound System is able to visualize the target vasculature (\>=70% with a 95% confidence interval) |
| Primary Performance: To have successful vascular access either by cannulation or blood return. | During the procedure | Successful access with the vascular access device, either by cannulation or blood return (\>=70% with a 95% confidence interval) |
| Primary Safety: To determine the incidence of device related adverse events, experienced by patient or user, when using the BD SiteRiteTM 9 Ultrasound System. | During the procedure and 15 minutes after the procedure | Rate of device related adverse events (\<2%). |
Countries
United States
Outcome results
None listed