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NCT Number: NCT07590063

Technology Development of Diagnostic Ultrasound System for Obstetric Imaging

This study collects obstetric ultrasound images from pregnant participants using the UIH uSONIQUE Nova diagnostic ultrasound system (uC7-1s transducer). The goal is to obtain standardized, high-quality images to support artificial intelligence (AI) algorithm development, AI training and validation, and automated obstetric measurement workflows. Results will support a premarket notification (510(k)) submission to the U.S. FDA.

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Key information

Conditions

Pregnancy

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

OHSU Perinatology and Genetics Clinic

Portland, Oregon, 97239, United States

Location contact

Adam Crosland, MD, MPH

CONTACT

[email protected]

503-494-6852

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

To be eligible to participate in this study, an individual must meet all of the following criteria:

  • Pregnant persons age 18-45 years
  • Single intrauterine pregnancy
  • Gestational duration: 18 - 28 weeks

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

  • Pregnant individuals with multi-fetal gestation (e.g., twins, triplets, etc.).
  • Pregnant individuals with suspected or known fetal anomaly, undergoing evaluation for genetic abnormality, requiring non-standard care, or diagnostic intervention.
  • Pregnant individuals with a medical or surgical history that may impact quality of ultrasound imaging:
  • Body Mass Index (BMI) > 40
  • Prior surgeries including: abdominal mesh placement; abdominoplasty
  • Vaginal bleeding within the last 6 weeks
  • Patients with serious medical comorbidities including: maternal congenital heart abnormalities; history of organ transplant; asthma exacerbation (during pregnancy); pre-eclampsia; recent mechanical trauma.
  • Use of any of the following during pregnancy: marijuana (or similar derivatives); alcohol; tobacco; methamphetamines; warfarin; isotretinoin; methotrexate; valproic acid; retinoids; oral steroids
  • Non-English speaking.
  • Participants deemed unsuitable by the investigator due to safety or data integrity.

Treatment and study plan

Diagnostic Ultrasound System

Device

Investigational diagnostic ultrasound system used to perform fetal anatomic survey of the maternal abdomen.

Other names: UIH uSONIQUE

Primary outcomes

  1. Complete Fetal Biometric Image Set Collection

    Time frame: Day 1

    Number of participants from whom complete fetal biometric image sets are successfully collected, including Biparietal Diameter (BPD), Head Circumference (HC), Abdominal Circumference (AC), and Femur Length (FL), in compliance with the study scanning protocol standards

Secondary outcomes

  1. Reference Dataset Creation

    Time frame: Within 4 months of study completion

    Completion of independent reviews by two qualified obstetricians, resolution of measurement discrepancies through adjudication, and establishment of final ground truth measurements for all collected biometric data

  2. Incidence of Adverse Events

    Time frame: Throughout study participation, up to 4 months

    Nature, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), including device-related complications and study discontinuations

Study contacts

Contact information is provided by the study sponsor or research team.

Adam Principal Investigator, MD, MPH

CONTACT

[email protected]

503-494-6852

Sponsors and collaborators

Lead sponsor

United Imaging Healthcare North America, Inc.

Industry

Collaborators

  • Oregon Health and Science University

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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