Clinical Performance Evaluation of the Artificial Intelligence (AI)/ Machine Learning (ML) Technologies Utilized by the Origin Medical EXAM ASSISTANT

Launched by ORIGIN MEDICAL SYSTEMS, INC. · Apr 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of advanced computer technology, known as Artificial Intelligence (AI) and Machine Learning (ML), to help interpret early pregnancy ultrasound scans. Specifically, the trial is focusing on women who are between 11 and 14 weeks pregnant and are having their first ultrasound to check on the baby’s development. The goal is to see how well this AI system performs compared to experienced doctors who are trained to read these ultrasound images.

To participate in the study, women must be at least 18 years old, have a healthy single baby (not twins or more), and have a body mass index (BMI) under 40. They also need to give their consent to join the trial. If eligible, participants will have their ultrasound images analyzed by both the AI system and a team of doctors, allowing researchers to compare the results. This study is currently recruiting participants, and it's a great opportunity to contribute to advancements in prenatal care.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Maternal age ≥ 18 years
• • 2. BMI \< 40 kg/m2
• • 3. Live non-anomalous singleton pregnancies
• 4. Gestational age between 11 weeks + 0 days and 13 weeks + 6 days, as determined by:
• • Last menstrual period (LMP) or, Ultrasound report if the the LMP date is uncertain Note: Gestational age determination follows standard American College of Obstetricians and Gynecologists (ACOG) guidelines.
• • 5. Informed consent is obtained from the participant
• • 6. Exams obtained as per the Image Acquisition Protocol
• Exclusion Criteria:
• • 1. Multiple Pregnancies
• • 2. Cases with fetal demise or other fetal abnormalities observed/suspected after the ultrasound examination
• • 3. Cases of planned diagnostic ultrasound follow-up exams within 2 weeks for known or suspected abnormality after the current ultrasound examination for the study