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NCT06952439 · ClinicalTrials.gov registry record
Clinical Performance Evaluation of the Artificial Intelligence (AI)/ Machine Learning (ML) Technologies Utilized by the Origin Medical EXAM ASSISTANT
A clinical trial of To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant Participants and First Trimester Pregnancy, sponsored by Origin Medical Systems.
- Completed
- Registry status
- 551
- Enrollment target
- 15
- Study locations
NCT06952439: Completed study of To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant Participants and First Trimester Pregnancy, sponsored by Origin Medical Systems.
NCT06952439 is a study of To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant Participants and First Trimester Pregnancy that has completed, run by Origin Medical Systems. The registered enrollment target is 551 participants. The trial reports 15 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06952439, a study of To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant Participants and First Trimester Pregnancy, has completed, sponsored by Origin Medical Systems.
- COMPLETED
- Registry status
- 551 participants
- Enrollment target
- 15
- Study locations
Study 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.
Primary Outcome
The overall sensitivity and two-sided 95% confidence interval (CI) will be determined using data pooled across diagnostic views. Note: The participant is assessed for the primary outcome on the same day of enrollment.
Conditions Studied
Interventions
- DEVICE Images and cines captured through the capture card (ICC)
Study Locations (15)
California
- Harbinder S Brar MD Inc - Apple Valley
- Harbinder S Brar MD Inc - Indio
- Harbinder S Brar MD Inc - Murrieta
- Harbinder S Brar MD Inc - Redlands
- Harbinder S Brar MD Inc - Riverside
- Harbinder S Brar MD Inc - San Bernardino
Oklahoma
- The Nest 4D Ultrasound LLC, DBA InFocus Ultrasound DBA Little Peanut 4D Ultrasound - Norman
- The Nest 4D Ultrasound LLC, DBA InFocus Ultrasound DBA Little Peanut 4D Ultrasound - Oklahoma City
- Tiny Blessings Ultrasound 4D Studio - Owasso
- Tiny Blessings Ultrasound 4D Studio - Skiatook
Texas
- Total Womens Care PLLC - Houston
- Reveal Ultrasound, LLC-S - Webster
Louisiana
- Sweet Pea 3D/4D Ultrasound Nola - New Orleans
New York
- Mobile Mama Ultrasound, LLC - Troy
North Carolina
- Mid-Carolina OB/GYN - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 551 participants |
| Start Date | 2025-03-19 |
| Est. Completion | 2025-05-19 |
What the finished NCT06952439 record still lists
NCT06952439 is an observational study that tracks outcomes without assigning an intervention. The registered 551 participants enrollment target is mid-sized for trials with a published cap.
The record links to 2 conditions, with To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant Participants appearing as the primary indexed condition, and to 1 intervention - of which Images and cines captured through the capture card (ICC) is the first listed.
NCT06952439 lists 15 locations in 6 states (California, Oklahoma, Texas).
Frequently Asked Questions
What is clinical trial NCT06952439 about?
NCT06952439 is a clinical study titled "Clinical Performance Evaluation of the Artificial Intelligence (AI)/ Machine Learning (ML) Technologies Utilized by the Origin Medical EXAM ASSISTANT". 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 tru...
What is the current status of trial NCT06952439?
This trial is currently completed. The enrollment target is 551 participants. The study started on 2025-03-19. Estimated completion is 2025-05-19.
What conditions does trial NCT06952439 study?
This clinical trial studies the following conditions: To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant Participants, First Trimester Pregnancy.
What interventions are being tested in trial NCT06952439?
The interventions under investigation include: Images and cines captured through the capture card (ICC) (DEVICE).
Who is sponsoring clinical trial NCT06952439?
This trial is sponsored by Origin Medical Systems, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06952439 being conducted?
This trial has 15 study locations across California, Louisiana, New York, North Carolina, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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