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

Completed

Conditions studied: To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant Participants, First Trimester Pregnancy

In brief

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.

Key facts

Study ID

NCT06952439

Run by

Origin Medical Systems, Inc.

People needed

551

Starts

2025-03-19

Expected to finish

2025-05-19

Last updated by the study team

2025-10-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Maternal age ≥ 18 years
• BMI < 40 kg/m2
• Live non-anomalous singleton pregnancies
• 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.
• Informed consent is obtained from the participant
• Exams obtained as per the Image Acquisition Protocol

You may not qualify if…

• Multiple Pregnancies
• Cases with fetal demise or other fetal abnormalities observed/suspected after the ultrasound examination
• Cases of planned diagnostic ultrasound follow-up exams within 2 weeks for known or suspected abnormality after the current ultrasound examination for the study

Where it is running

• Harbinder S Brar MD Inc — Apple Valley, California, United States
• Harbinder S Brar MD Inc — Indio, California, United States
• Harbinder S Brar MD Inc — Murrieta, California, United States
• Harbinder S Brar MD Inc — Redlands, California, United States
• Harbinder S Brar MD Inc — Riverside, California, United States
• Harbinder S Brar MD Inc — San Bernardino, California, United States
• Sweet Pea 3D/4D Ultrasound Nola — New Orleans, Louisiana, United States
• Mobile Mama Ultrasound, LLC — Troy, New York, United States
• Mid-Carolina OB/GYN — Raleigh, North Carolina, United States
• The Nest 4D Ultrasound LLC, DBA InFocus Ultrasound DBA Little Peanut 4D Ultrasound — Norman, Oklahoma, United States
• The Nest 4D Ultrasound LLC, DBA InFocus Ultrasound DBA Little Peanut 4D Ultrasound — Oklahoma City, Oklahoma, United States
• Tiny Blessings Ultrasound 4D Studio — Owasso, Oklahoma, United States
• Tiny Blessings Ultrasound 4D Studio — Skiatook, Oklahoma, United States
• Total Womens Care PLLC — Houston, Texas, United States
• Reveal Ultrasound, LLC-S — Webster, Texas, United States

Full record on ClinicalTrials.gov

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