NCT06068413已完成不适用
A Retrospective, Multicenter, Multiple-viewer-multiple-case (MRMC) Clinical Trial to Evaluate the Safety and Efficacy of CT Image-assisted Detection Software for Focal Liver Lesions
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2023年4月1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
- 376
- 试验地点
- 1
- 主要终点
- AFROC
研究概览
简要总结
To evaluate the safety and effectiveness of the developed and produced CT image-assisted detection software for focal liver lesions before being put into the market.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •doctors have liver CT scanning experience more than 1 year;
排除标准
- •persons don't have the license of practicing physician; doctors don't have liver CT scanning experience or have liver CT scanning experience less than 1 year;
结局指标
主要结局
AFROC
时间窗: 1 year
Under different confidence scores, the number of accurately located lesions/the number of true lesions determined by the reference standard was taken as the ordinate coordinate, and (1- the number of negative cases determined by the reference standard/the total number of true negative cases diagnosed by the reference standard) was plotted as the horizontal coordinate
次要结局
未报告次要终点
研究者
研究点 (1)
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