Clinical trialNCT06952439CompletedObservational

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

SponsorOrigin Medical Systems, Inc.Enrollment551First Trimester PregnancyTo Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant Participants

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Jeroen Peter Vanderhoeven, MD
Providence Swedish Medical Center
Principal Investigator
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

15 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

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

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 19 Mar 2025
Primary completion: 19 May 2025
Completion: 19 May 2025
Last update posted: 21 Oct 2025
Registered enrollment: 551
Registry id: NCT06952439

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.