Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Israel
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Obtain Image sets using Ultrasound Venue System
研究概览
简要总结
The study purpose is to collect images and user feedback from the Next Generation Venue Ultrasound system, components, and accessories under clinical conditions, as required for device development and optimization.
详细描述
Adult patients (aged >18 years) will be enrolled that present for emergency or immediate medical care, in facilities such as the intensive care unit (ICU), US unit, and/or other departments. Subjects may or may not have a clinical indication for ultrasound scanning as part of their regular medical care and will be required to meet the inclusion criteria and none of the exclusion criteria. If a subject has a clinical indication for ultrasound exam, the routine exam will be performed with the standard equipment, and an additional exam will be performed using the investigational ultrasound device.
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
- •Adults (aged 18 years of age or older) at the time of consent;
- •Eligible to undergo ultrasound scanning per the site standard of care (with or without a clinical indication for scanning);
- •Able and willing to provide written informed consent for participation
排除标准
- •Are pregnant subjects
- •Require procedures that cannot be readily completed using available investigational devices;
- •Require or are anticipated to require medical care where study participation could reasonably be expected to adversely impact patient care.
研究组 & 干预措施
Eligible Subjects
All subjects will be enrolled into a single arm and will undergo an ultrasound exam, per the protocol.
干预措施: Ultrasound (Device)
结局指标
主要结局
Obtain Image sets using Ultrasound Venue System
时间窗: Two months
Number of representative image sets for subjects enrolled in study
Periodic user feedback
时间窗: Two months
Periodic user feedback data (Clinician User Preference Survey) from device users on device performance for quality optimization. The feedback will not be aggregated or statistically analyzed. The scale is a 1-5 Likert score (1 - Poor, 2 - Needs Improvement, 3 - As expected/Equal, 4 - Better then expected, 5 - Excellent) There is no total score.
次要结局
未报告次要终点