NCT06392555已完成不适用
Fetal Heart Ultrasound Suspicious Radiographic Finding Identification - Reader Study
BrightHeart1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年5月3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
- 200
- 试验地点
- 1
- 主要终点
- AUC of the ROC curve for the presence of any suspicious finding
研究概览
简要总结
Clinical performance of the device will be evaluated in a fully-crossed, multiple-reader multiple-case (MRMC) study. This study will be used to determine the impact of the device on reader performance in identifying suspicious radiographic findings in fetal heart ultrasound video clips recorded during 2nd trimester anatomic ultrasound examinations conducted during the second trimester of the pregnancy.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ultrasound examinations conducted during the second trimester of the pregnancy
- •fetus between 18 and 24 weeks of gestational age
- •mothers 18 years old or older
排除标准
- •exams corresponding to multiple pregnancy
- •fetal heterotaxy
- •exams not containing video clips with interpretable 4-chamber (4C), Left Ventricular Outflow Tract (LVOT) or Right Ventricular Outflow Tract (RVOT) standard views
结局指标
主要结局
AUC of the ROC curve for the presence of any suspicious finding
时间窗: 1 month
AUC of the ROC curve for both reading conditions (aided vs unaided by the device) derived from the identification of any suspicious radiographic finding
次要结局
- Sensitivity and specificity for both reading conditions for the presence of each suspicious finding(1 month)
- Sensitivity and specificity for both reading conditions for the presence of any suspicious finding(1 month)
- AUC of the ROC curve for the presence of each suspicious finding(1 month)
研究者
研究点 (1)
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