AutoFUSE or First-Trimester Ultrasound Scan
Validation of an AI-based Intelligent Image Quality Control System for First-Trimester Ultrasound Scan: a Stepwise, Multicenter, Randomized Clinical Trial in China
The goal of this clinical trial is to validate the clinical application capabilities of AutoFUSE. The main questions it aims to answer are:
Does AutoFUSE reduce the time required to obtain standard planes in first-trimester ultrasound scan? Does AutoFUSE improve the accuracy of standard plane acquisition in first-trimester ultrasound scan? What safety outcomes occur in participants undergoing AutoFUSE-assisted ultrasound examination? Researchers will compare AutoFUSE-assisted ultrasound scan with standard clinical protocol (SCP) ultrasound scan to evaluate the efficacy and safety of AutoFUSE in clinical practice.
Participants will:
Undergo either AutoFUSE-assisted ultrasound scan or standard clinical ultrasound scan according to the study design.
Complete scheduled visits for examinations, data collection and follow-up. Provide information related to scan time, image quality and safety during the study.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Hubei
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Wuhan、Hubei、中国、430022
- Wuhan Union Hospital
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接触：
- Lei Chen, MD
- 电话号码：15971480677
- 邮箱：chan0812@126.com
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Wuhan、Hubei、中国、430060
- Renmin Hospital of Wuhan University
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接触：
- Yong Luo, PhD
- 电话号码：15210624692
- 邮箱：chan0812@126.com
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Wuhan、Hubei、中国、430022
- Zhongnan Hospital of Wuhan University
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接触：
- Huangxuan Zhao, PhD
- 电话号码：18971676985
- 邮箱：zhao_huangxuan@sina.com
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-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
① Pregnant women undergoing fetal ultrasound examination.
② A singleton pregnancy with a live fetus between 11 and 13+6 weeks with complete outcomes.
Exclusion Criteria:
Incomplete pregnancy outcome information.
Unexplained miscarriages. ③ Fetal death.
Pregnancies with significant maternal complications.
- Multiple pregnancies.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：AutoFUSE-assisted ultrasound scan
AutoFUSE-assisted ultrasound scanning throughout the examination.
|
AutoFUSE is an AI-based intelligent image quality control system independently developed for first-trimester fetal ultrasound scan (FTFUS).
|
|
有源比较器：Traditional ultrasound scan
Standard ultrasound scanning according to the standard clinical protocol.
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Traditional ultrasound scan means the standard clinical ultrasound examination performed by sonographers using routine manual operation to acquire predefined standard anatomical planes, without real-time AI assistance, automatic plane recognition, or automatic image quality assessment.
All plane acquisition and quality evaluation are completed manually by the operator.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The efficiency of standard plane acquisition
大体时间：Day 1
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The primary outcome was measured by the time required to obtain the prespecified standard planes during the ultrasound examination.
|
Day 1
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The accuracy of standard plane acquisition
大体时间：Through study completion, an average of 6 months
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The secondary outcome was assessed by whether the prespecified standard planes are correctly obtained according to predefined imaging criteria.
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Through study completion, an average of 6 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- AutoFUSE-001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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