At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Prospective Multicenter Study to Evaluate the Performance of the Artificial Intelligence (AI)/ Machine Learning (ML) Technologies Utilized by the Origin Medical EXAM ASSISTANT
In Brief
An observational study evaluating Images and cines captured through the capture card (ICC) for To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant Participants and First Trimester Pregnancy. Completed, enrolled 551 participants across 15 sites.
Detailed Summary
A multicenter study will be conducted to assess the role of the AI/ML technologies of Origin Medical EXAM ASSISTANT (OMEA) in interpreting first-trimester fetal ultrasound examinations (11 weeks 0 days - 13 weeks 6 days). The performance of the AI-based system will be compared against the ground truth provided by an independent reading panel of maternal-fetal medicine physicians.
Study Details
Timeline
Interventions
A screen capture/recording of the entire exam performed by the ARDMS as per the Image Acquisition Protocol for the FDA Study will be obtained, and the images/cines required for the study that correspond to IUS shall be obtained. The independent research coordinator for the study will review the screen recording and identify the frame/cine for each diagnostic view (ICC) that corresponds to IUS based on the time stamps.