Clinical Performance Evaluation of the Artificial Intelligence (AI)/ Machine Learning (ML) Techno… (NCT06952439) | Clinical Trial Compass
CompletedNot Applicable
Clinical Performance Evaluation of the Artificial Intelligence (AI)/ Machine Learning (ML) Technologies Utilized by the Origin Medical EXAM ASSISTANT
United States551 participantsStarted 2025-03-19
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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:
. Informed consent is obtained from the participant
. Exams obtained as per the Image Acquisition Protocol
Exclusion criteria
. Multiple Pregnancies
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To assess whether the AI/ML technologies used in OMEA can achieve an acceptable sensitivity for identifying the diagnostic view
Timeframe: 11 weeks 0 days to 13 weeks 6 days
2
To assess whether the AI/ML technologies used in OMEA can achieve an acceptable sensitivity and consistency for verifying the quality criteria of a given image
Timeframe: 11 weeks 0 days to 13 weeks 6 days
3
To evaluate the performance of the OMEA AI/ML technologies with respect to facilitating the determination of quantitative measure of crown-rump length (CRL) and nuchal translucency (NT), complementary evaluations of agreement will be performed.
. 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