Role of Artificial Intelligence in Fetal Imaging Workflows, Prospective evaluation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- 1. Evaluate the diagnostic agreement between OMEA(Origin Medical Exam Assistant, a browser-based software as a medical device)- assisted examinations and traditional examinations
研究概览
简要总结
Antenatal ultrasonography aids in assessing the growth of the fetus along with the birth abnormalities, enabling the fetus to receive timely and effective treatment before or after the delivery. Origin Medical Exam Assistant(OMEA) is a browser-based software as a medical device(SaMD) intended to aid Healthcare professionals(HCPs) in the analysis and interpretation of fetal/obstetric images and clips using Artificial Intelligence(AI)/Machine learning(ML) algorithms in real-time during fetal/obstetric examinations.
In traditional fetal ultrasound imaging, multiple factors affect the accuracy of the ultrasound examination, such as high fetal mobility, excessive maternal abdominal thickness, HCP’s skills and experience, and inter-observer variability. Moreover, the traditional fetal ultrasound significantly impacts the clinical workflow by increasing the workload leading to longer examination times, causing diagnostic delays that negatively impact patient outcomes, necessitating more equipment and highly trained HCPs.
Recent advancements in AI/ML are revolutionizing the field of radiology by augmenting the capabilities of HCPs, improving diagnostic accuracy and enhancing patient care outcomes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- Female
入选标准
- •Normal and Singleton pregnancies with no clinical indications of fetal anomaly prior to the exam
- •Gestational age between 11weeks+ 0 days to 13 weeks +6 days by last menstrual date(LMP) or ultrasound report if uncertain LMP.
排除标准
- •Multiple pregnancies
- •Non-readable images(i.e., images with excessive shadows).
结局指标
主要结局
1. Evaluate the diagnostic agreement between OMEA(Origin Medical Exam Assistant, a browser-based software as a medical device)- assisted examinations and traditional examinations
时间窗: Gestational age of fetus between 11 to 13 weeks and 6 days
2. Assess the precision of fetal/obstetric measurements obtained with OMEA compared to standard practices
时间窗: Gestational age of fetus between 11 to 13 weeks and 6 days
3. Determine the feasibility of introducing OMEA in the real-clinical setting
时间窗: Gestational age of fetus between 11 to 13 weeks and 6 days
次要结局
- 1. In accordance with practice guidelines, Sensitivity and Specificity of the OMEA in :(a) Detecting diagnostic views from obstetric ultrasound examinations)
研究者
Dr K Aparna Sharma
AIIMS New Delhi