NCT04983953已完成不适用
An Open Label, Single-Center and Random-Selection Retrospective Pivotal Study of Clinical Decision Support System for Intracranial Hemorrhage Using Brain CT Images
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Heuron Inc.
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of cHS
研究概览
简要总结
cHS is a software that has been pre-learned based on a intracranial haemorrhage diagnosis model using brain CT images, and clinical decision support system for diagnosing intracranial haemorrhage by automatically analyzing brain CT images by assisting the medical team.
The specific aims of this study are to evaluate efficacy of cHS for intracranial haemorrhage compared to the sensitivity and specificity levels of predicate device which is currently approved to triage intracranial haemorrhage.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults over 19 years old
- •Brain CT acquired
- •Abnormal cohort: A patient diagnosed with intracranial haemorrhage after a brain CT scan
- •Normal cohort: A normal person or a patient not diagnosed with intracranial haemorrhage after a brain CT scan
排除标准
- •Patients with brain tumor or cerebral toxoplasmosis
- •Patients with brain abscess or brain calcification
- •Poor or incomplete brain CT image quality
结局指标
主要结局
Sensitivity and specificity of cHS
时间窗: Within 4 weeks after collecting data
Sensitivity and specificity of cHS in diagnosis of intracranial haemorrhage based on golden standards
次要结局
未报告次要终点
研究者
研究点 (1)
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