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

Description

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

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Study Overview

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Study Details

Study overview

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.

Prospective Multicenter Study to Evaluate the Performance of the Artificial Intelligence (AI)/ Machine Learning (ML) Technologies Utilized by the Origin Medical EXAM ASSISTANT

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

Condition
To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant Participants
Intervention / Treatment

-

Contacts and Locations

Apple Valley

Harbinder S Brar MD Inc, Apple Valley, California, United States, 92307

Indio

Harbinder S Brar MD Inc, Indio, California, United States, 92201

Murrieta

Harbinder S Brar MD Inc, Murrieta, California, United States, 92562

Redlands

Harbinder S Brar MD Inc, Redlands, California, United States, 92374

Riverside

Harbinder S Brar MD Inc, Riverside, California, United States, 92506

San Bernardino

Harbinder S Brar MD Inc, San Bernardino, California, United States, 92404

New Orleans

Sweet Pea 3D/4D Ultrasound Nola, New Orleans, Louisiana, United States, 70002

Troy

Mobile Mama Ultrasound, LLC, Troy, New York, United States, 12180

Raleigh

Mid-Carolina OB/GYN, Raleigh, North Carolina, United States, 27607

Norman

The Nest 4D Ultrasound LLC, DBA InFocus Ultrasound DBA Little Peanut 4D Ultrasound, Norman, Oklahoma, United States, 73072

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 5. Informed consent is obtained from the participant
  • 6. Exams obtained as per the Image Acquisition Protocol
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Origin Medical Systems, Inc.,

Jeroen Peter Vanderhoeven, MD, PRINCIPAL_INVESTIGATOR, Providence Swedish Medical Center

Study Record Dates

2025-12-30