Human Factoring Validation Testing of the Pulsenmore ES Home Ultrasound Monitoring Device for Conducting Fetal Scans During Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PulseNmore
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Safety issues while using Pulsenmore ES device
研究概览
简要总结
The goal of this study is to conduct human factors validation testing with the Pulsenmore ES home Ultrasound device in the video-guided mode of operation (participants) and the clinician-guided mode of operation (participants and healthcare professionals (HCP)) to evaluate whether the device/user interface can be used by the intended users without any serious issues or errors under that intended use and actual use conditions. The intended users will be qualitatively assessed via observation and cognitive debrief and usability testing methodology. Participants will be remotely observed during the video-guided fetal scanning actual process and participants and HCPs will be remotely observed during the clinician-guided fetal scanning actual process.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Safety issues while using Pulsenmore ES device
时间窗: One day
Any safety issue, either serious that could cause serious injury or death to the user, or non serious
User error while using Pulsenmore ES device
时间窗: One day
Any user interface issues reported by study participants and HCPs that can cause delay in diagnosis or treatment
次要结局
未报告次要终点
