Evaluating AI in First Trimester Ultrasound Imaging
Prospective Multicenter Study to Evaluate the Performance of the Artificial Intelligence (AI)/ Machine Learning (ML) Technologies Utilized by the Origin Medical EXAM ASSISTANT
This study is testing whether an AI tool can accurately interpret early pregnancy ultrasounds compared to expert doctors to see if it can help improve the quality of the images.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Origin Medical Systems, Inc. Industry-sponsored |
| Locations | 15 sites (Apple Valley, California and 14 other locations) |
| Trial ID | NCT06952439 on ClinicalTrials.gov |
What this trial studies
This multicenter observational study aims to assess the clinical performance of the Artificial Intelligence/Machine Learning technologies utilized by the Origin Medical EXAM ASSISTANT in interpreting first-trimester fetal ultrasound examinations. The study will collect a dataset of at least 289 ultrasound examinations from pregnant participants between 11 weeks 0 days and 13 weeks 6 days of gestation. The AI system's performance will be compared against evaluations made by an independent panel of maternal-fetal medicine physicians to validate its accuracy in detecting diagnostic views and verifying quality criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant individuals aged 18 years or older, with a singleton pregnancy between 11 weeks 0 days and 13 weeks 6 days of gestation.
Not a fit: Patients with multiple pregnancies, fetal abnormalities, or those requiring follow-up exams for known issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy and efficiency of ultrasound examinations in early pregnancy, leading to better prenatal care.
How similar studies have performed: Other studies have shown promise in utilizing AI/ML technologies for medical imaging, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Apple Valley, California and 14 other locations
- Harbinder S Brar MD Inc — Apple Valley, California, United States (Completed)
- Harbinder S Brar MD Inc — Indio, California, United States (Completed)
- Harbinder S Brar MD Inc — Murrieta, California, United States (Completed)
- Harbinder S Brar MD Inc — Redlands, California, United States (Completed)
- Harbinder S Brar MD Inc — Riverside, California, United States (Completed)
- Harbinder S Brar MD Inc — San Bernardino, California, United States (Completed)
- Sweet Pea 3D/4D Ultrasound Nola — New Orleans, Louisiana, United States (Recruiting)
- Mobile Mama Ultrasound, LLC — Troy, New York, United States (Completed)
- Mid-Carolina OB/GYN — Raleigh, North Carolina, United States (Completed)
- The Nest 4D Ultrasound LLC, DBA InFocus Ultrasound DBA Little Peanut 4D Ultrasound — Norman, Oklahoma, United States (Completed)
- The Nest 4D Ultrasound LLC, DBA InFocus Ultrasound DBA Little Peanut 4D Ultrasound — Oklahoma City, Oklahoma, United States (Completed)
- Tiny Blessings Ultrasound 4D Studio — Owasso, Oklahoma, United States (Completed)
- Tiny Blessings Ultrasound 4D Studio — Skiatook, Oklahoma, United States (Completed)
- Total Womens Care PLLC — Houston, Texas, United States (Completed)
- Reveal Ultrasound, LLC-S — Webster, Texas, United States (Completed)
Study contacts
- Principal investigator: Jeroen Peter Vanderhoeven, MD — Providence Swedish Medical Center
- Study coordinator: Sripad Krishna Devalla, Ph.D.
- Email: sripad@originmedical.ai
- Phone: +91 9003296930
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.