跳至主要内容
临床试验/NCT06567067
NCT06567067已完成不适用

Human Factoring Validation Testing of the Pulsenmore ES Home Ultrasound Monitoring Device for Conducting Fetal Scans During Pregnancy

PulseNmore2 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2023年2月9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
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

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

研究者

发起方
PulseNmore
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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