Status:
COMPLETED
Clinical Performance Evaluation of the Artificial Intelligence (AI)/ Machine Learning (ML) Technologies Utilized by the Origin Medical EXAM ASSISTANT
Lead Sponsor:
Origin Medical Systems, Inc.
Conditions:
To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant Participants
First Trimester Pregnancy
Eligibility:
FEMALE
18+ years
Brief 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 day...
Detailed Description
Study Brief: A multicenter, prospective observational study shall be conducted for the performance assessment and validation of the AI/ML technologies used in OMEA for the automated assessment of the...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 19 2025
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 19 2025
Estimated Enrollment :
551 Patients enrolled
Trial Details
Trial ID
NCT06952439
Start Date
March 19 2025
End Date
May 19 2025
Last Update
October 21 2025
Active Locations (15)
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1
Harbinder S Brar MD Inc
Apple Valley, California, United States, 92307
2
Harbinder S Brar MD Inc
Indio, California, United States, 92201
3
Harbinder S Brar MD Inc
Murrieta, California, United States, 92562
4
Harbinder S Brar MD Inc
Redlands, California, United States, 92374