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AI assistant aims to sharpen early pregnancy scans

NCT ID NCT06952439

Diagnosis Sponsor: Origin Medical Systems, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an artificial intelligence (AI) tool called the Origin Medical EXAM ASSISTANT to see how well it can interpret first-trimester fetal ultrasound images. Researchers compared the AI's readings to those of a panel of expert doctors. The goal was to check if the AI could reliably identify important views and measurements in early pregnancy scans.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

551 people

The number who actually took part.

Started

Mar 2025

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Origin Medical EXAM ASSISTANT™ is indicated for use during the first trimester (11 weeks 0 days to 13 weeks 6 days) fetal/obstetric ultrasound examinations of normal singleton pregnancies.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion 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: Last menstrual period (LMP) or, Ultrasound report if the the LMP date is uncertain Note: Gestational age determination follows standard American College of Obstetricians and Gynecologists (ACOG) guidelines. 5. Informed consent is obtained from the participant 6. Exams obtained as per the Image Acquisition Protocol Exclusion Criteria: 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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

First trimester pregnancy To validate the clinical performance of ai/ML technologies in first-trimester pregnant participants

Contacts and locations

Locations

  • 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

  • Mid-Carolina OB/GYN

    Raleigh, North Carolina, 27607, United States

  • Mobile Mama Ultrasound, LLC

    Troy, New York, 12180, United States

  • Reveal Ultrasound, LLC-S

    Webster, Texas, 77598, United States

  • Sweet Pea 3D/4D Ultrasound Nola

    New Orleans, Louisiana, 70002, 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

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