Technology Development of Diagnostic Ultrasound System for Obstetric Imaging

Starting soon

Conditions studied: Pregnancy

In brief

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.

Key facts

Study ID

NCT07590063

Run by

United Imaging Healthcare North America, Inc.

People needed

50

Starts

2026-05-06

Expected to finish

2026-09-30

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• OHSU Perinatology and Genetics Clinic — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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