Clinical Evaluation of the Next Generation Venue Ultrasound System, Components, and Accessories - Canada
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Periodic user feedback
研究概览
简要总结
The purpose of the study is to collect images data sets from clinical cases and periodic user feedback on the Next Generation Venue ultrasound system under clinical conditions. This is a medical device study designed as a clinical, open label, unblinded, non-randomized, prospective, feasibility research study.
详细描述
Adult patients (aged >18 years) will be enrolled as they present for emergency or immediate medical care, in facilities such as the intensive care unit (ICU), cardiac care unit (CCU), 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. Eligible subjects will undergo an ultrasound exam using the investigational ultrasound device. The exam type will be based on the subject's clinical condition. Users performing the scans will periodically be asked to provide feedback on User Survey forms prepared by the Sponsor. Image data sets from investigational exam will be stored electronically and de-identified data will be disclosed to the Sponsor.Results are for use in development and optimization of a next generation ultrasound system being developed by study Sponsor, GE Healthcare (GEHC) prior to future commercial release.
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); AND
- •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; OR
- •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 exam (Device)
结局指标
主要结局
Periodic user feedback
时间窗: Two months
Periodic user feedback data from device users.
Obtain Image sets using Ultrasound Venue System
时间窗: Two months
Number of representative image sets for subjects enrolled in study
次要结局
未报告次要终点