Validation of an AI-based Intelligent Image Quality Control System for First-Trimester Ultrasound Scan: a Stepwise, Multicenter, Randomized Clinical Trial in China
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 试验地点
- 3
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •① Pregnant women undergoing fetal ultrasound examination.
- •② A singleton pregnancy with a live fetus between 11 and 13+6 weeks with complete outcomes.
排除标准
- •Incomplete pregnancy outcome information.
- •Unexplained miscarriages. ③ Fetal death.
- •Pregnancies with significant maternal complications.
- •Multiple pregnancies.