NCT04792632Unknown不适用
Clinical Performance Evaluation of Veye Lung Nodules
Aidence1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2021年3月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Detection accuracy
研究概览
简要总结
Veye Lung Nodules (Aidence B.V., Amsterdam, the Netherlands) is a medical software device that is intended to assist radiologists with pulmonary nodule management on CT chest scans.
This clinical trial aims to assess the clinical performance of Veye Lung nodules via a standalone performance evaluation and a reader study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Retrospective
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
- •Subjects that underwent a CT chest scan for either lung cancer screening or routine practice
排除标准
- •Subjects with >10 pulmonary nodules;
- •Subjects with pulmonary mass(es) = largest axial diameter >30mm;
- •Subjects with interstitial lung disease.
结局指标
主要结局
Detection accuracy
时间窗: 2 months
Demonstrate that the accuracy for detecting actionable pulmonary nodules by radiologists using the device (AIDED) is superior to that of radiologists not using the device (UNAIDED)
次要结局
- Segmentation accuracy(1 month)
研究者
研究点 (1)
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