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

NCT06952439 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 551

Last updated 2025-10-21

No results posted yet for this 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.

Conditions

  • To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant Participants
  • First Trimester Pregnancy

Interventions

DEVICE

Images and cines captured through the capture card (ICC)

A screen capture/recording of the entire exam performed by the ARDMS as per the Image Acquisition Protocol for the FDA Study will be obtained, and the images/cines required for the study that correspond to IUS shall be obtained. The independent research coordinator for the study will review the screen recording and identify the frame/cine for each diagnostic view (ICC) that corresponds to IUS based on the time stamps.

Sponsors & Collaborators

  • Origin Medical Systems, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeroen Peter Vanderhoeven, MD · Providence Swedish Medical Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-03-19
Primary Completion
2025-05-19
Completion
2025-05-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06952439 on ClinicalTrials.gov