COMPLETED

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

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Conditions

To Validate the Clinical Performance of AI/ML Technologies in First-trimester Pregnant ParticipantsFirst Trimester PregnancyArtificial IntelligenceMachine LearningUltrasound Imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-19
Study Completion:2025-05-19
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06952439

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Maternal age ≥ 18 years
  2. 2. BMI \< 40 kg/m2
  3. 3. Live non-anomalous singleton pregnancies
  4. 4. Gestational age between 11 weeks + 0 days and 13 weeks + 6 days, as determined by:
  5. 5. Informed consent is obtained from the participant
  6. 6. Exams obtained as per the Image Acquisition Protocol
  1. 1. Multiple Pregnancies
  2. 2. Cases with fetal demise or other fetal abnormalities observed/suspected after the ultrasound examination
  3. 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

Contacts and Locations

Principal Investigator

Jeroen Peter Vanderhoeven, MD
PRINCIPAL_INVESTIGATOR
Providence Swedish Medical Center

Study Locations (Sites)

Harbinder S Brar MD Inc
Apple Valley, California, 92307
United States
Harbinder S Brar MD Inc
Indio, California, 92201
United States
Harbinder S Brar MD Inc
Murrieta, California, 92562
United States
Harbinder S Brar MD Inc
Redlands, California, 92374
United States
Harbinder S Brar MD Inc
Riverside, California, 92506
United States
Harbinder S Brar MD Inc
San Bernardino, California, 92404
United States
Sweet Pea 3D/4D Ultrasound Nola
New Orleans, Louisiana, 70002
United States
Mobile Mama Ultrasound, LLC
Troy, New York, 12180
United States
Mid-Carolina OB/GYN
Raleigh, North Carolina, 27607
United States
The Nest 4D Ultrasound LLC, DBA InFocus Ultrasound DBA Little Peanut 4D Ultrasound
Norman, Oklahoma, 73072
United States
The Nest 4D Ultrasound LLC, DBA InFocus Ultrasound DBA Little Peanut 4D Ultrasound
Oklahoma City, Oklahoma, 73106
United States
Tiny Blessings Ultrasound 4D Studio
Owasso, Oklahoma, 74055
United States
Tiny Blessings Ultrasound 4D Studio
Skiatook, Oklahoma, 74070
United States
Total Womens Care PLLC
Houston, Texas, 77018
United States
Reveal Ultrasound, LLC-S
Webster, Texas, 77598
United States

Collaborators and Investigators

Sponsor: Origin Medical Systems, Inc.

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-19
Study Completion Date2025-05-19

Study Record Updates

Study Start Date2025-03-19
Study Completion Date2025-05-19

Terms related to this study

Keywords Provided by Researchers

  • Artificial Intelligence
  • Machine Learning
  • First Trimester Pregnancy
  • Ultrasound Imaging

Additional Relevant MeSH Terms

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