BD SiteRite(TM) 9 Ultrasound System - Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Primary Performance: To provide visualization of the target vessel in which to insert the chosen vascular access device.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Primary Performance: To provide visualization of the target vessel in which to insert the chosen vascular access device.
时间窗: 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.
时间窗: 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.
时间窗: During the procedure and 15 minutes after the procedure
Rate of device related adverse events (\<2%).
次要结局
未报告次要终点