NCT05660044已完成不适用
Human Factors Validation Study of Artificial Intelligence Ultrasound Navigation Software for Cardiac Imaging
UltraSight1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2022年7月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Usability of UltraSight AI guidance software
研究概览
简要总结
The Product is a machine learning software, that utilizes AI to provide real-time guidance to acquire diagnostic-quality ultrasound views of the heart.
详细描述
Participants are healthcare professionals, who are not performing echocardiography on a routine basis. Participants attend a short training session to learn the software, then have a memory-decay period, followed by an individual simulated-use scanning session, lasting up to 60 minutes with a Moderator at the heart institute.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 and older
- •Novice users or medical professionals who do not perform echocardiographs as part of their routine job responsibilities.
- •Have the capacity to understand study risks and consent to be in the study
- •Be available and willing to participate in the study
- •Not be employed by the Sponsor or another medical device or pharmaceutical company
排除标准
- 未提供
结局指标
主要结局
Usability of UltraSight AI guidance software
时间窗: 10 days
Demonstrate that the Product can be used by the intended users by a questionnaire that is filled by an observation moderator which will assess the ease of use and user satisfaction
次要结局
未报告次要终点
研究者
研究点 (1)
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