Data Collection for Next Generation Ultrasound Technology Development
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Number of Diagnostic Ultrasound Exams
研究概览
简要总结
The study is designed to collect data from a ultrasound device being used to evaluate feasibility of next generation algorithms for ultrasound data processing and does not test any health outcome.
详细描述
The study is designed to collect data from a ultrasound device being used to evaluate feasibility of next generation algorithms for ultrasound data processing and does not test any health outcome. All eligible adults (aged 18 or older) will contribute case data from a convenience sample of maintenance hemodialysis population available at the study site and consistent with feasibility assessment of the technology. A relatively large feasibility population is used due to the need to test feasibility of multiple features across variations within this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are adults (aged 18 years of age or older) at the time of consent;
- •Are undergoing maintenance hemodialysis (MHD); AND
- •Are able and willing to provide written informed consent for participation
排除标准
- •Have anatomical characteristics or comorbid medical conditions that prevent completion of ultrasound scanning using the study device; OR
- •Are potentially put at additional risk by participating, in the opinion of the investigator.
研究组 & 干预措施
MHD Population Ultrasound
Eligible subjects in a convenience population at the site (Maintenance Hemodialysis, MHD) incidentally undergoingnon-invasive cardiac, pulmonary, and abdominal ultrasound scanning on the commercially available GE Vivid S70 system for use in testing feasibility of new algorithms for processing this data.
干预措施: Ultrasound scan (Device)
结局指标
主要结局
Number of Diagnostic Ultrasound Exams
时间窗: 1 day
Collection (number) of ultrasound images representative of sonographic findings routinely observed in the general imaging population.
次要结局
未报告次要终点