NCT05194436已完成不适用
A Pilot Study to Assess Aevice Medical Device for Detection of Wheeze in Pediatric Subjects and Use for Remote Auscultation
Aevice Health Pte. Ltd.1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2021年4月23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
- 35
- 试验地点
- 1
- 主要终点
- Wheeze is detected by physician and AeviceMD
研究概览
简要总结
The primary objective of this study is to determine if Aevice Medical Device can detect wheeze as accurately as a physician through auscultation. The secondary objective is to investigate if Aevice Medical Device can be used for remote auscultation of the lung.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is willing and parents/guardians are able to give informed consent for participation in the study.
- •Male or Female, aged 3 -18 years.
- •Presenting with wheeze.
- •Able (in the Investigators opinion) and willing to comply with all study requirements
排除标准
- •Any other significant disease or disorder which, in the opinion of the Investigator, may either put the subjects at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.
结局指标
主要结局
Wheeze is detected by physician and AeviceMD
时间窗: 60 Seconds
Primary end point of wheeze will be captured in a binary fashion (i.e. PRESENT or NOT PRESENT) on the CRF by the physician during manual auscultation. AeviceMD will perform wheeze analysis on each 5 sec of recording
次要结局
- Respiratory sounds are detected and identified by onsite physician and offsite (remote) physician(150 Seconds)
研究者
研究点 (1)
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