NCT04532580已完成不适用
Clinical Validation of Boneview for FDA Submission: Evaluation of the Ability of the Artificial Intelligence Software, Boneview, to Improve Physicians' and Radiologists' Performances in Detecting Fractures on Bone X-Rays Radiographs.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gleamer
- 入组人数
- 480
- 试验地点
- 1
- 主要终点
- measurement of diagnosis performances via calculation of sensitivity, specificity, NPV, PPV
研究概览
简要总结
The goal of this clinical validation is to assess comparative performances of physicians with and without the assistance of BoneView for the diagnosis of fractures on radiographs.
The performances are evaluated in terms of accuracy (primary endpoint with the pair specificity/sensitivity and the secondary endpoint PPV/NPV) and in terms of time needed for diagnosis (secondary endpoint with the measurement of time on each case).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Anonymized standard X-ray exams of extremity/pelvis/rib cage/dorsolumbar spine not containing or containing fracture(s).
- •Adult patient, with minimum age of 21 years old.
排除标准
- •Exams with one or more images including a body part not concerned by the intended use of BoneView (skull and cervical spine)
- •Cases with one or more images being used for model design and development.
- •Exams with one or more images being of poor quality (lossy), which prevent a proper interpretation by the readers.
- •Cases not containing a medically relevant number of views for correct diagnosis.
结局指标
主要结局
measurement of diagnosis performances via calculation of sensitivity, specificity, NPV, PPV
时间窗: 1 month
calculation of sensitivity, specificity, NPV, PPV and comparison between the two cohorts
次要结局
- Time needed for diagnosis via measurement of the time before submission of the diagnosis(1 month)
研究者
研究点 (1)
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