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Clinical Trials in the USA / NCT07590063
Starting soon Observational

Technology Development of Diagnostic Ultrasound System for Obstetric Imaging

NCT07590063 · tracked via the Priya Life Science USA tracker
Sponsor
United Imaging Healthcare North America, Inc.
Phase
Observational
Started
2026-05-06
Last updated
2026-05-15

Condition(s) studied

Pregnancy

Investigational drug(s) / intervention(s)

Diagnostic Ultrasound System

Diagnostic Ultrasound System: Investigational diagnostic ultrasound system used to perform fetal anatomic survey of the maternal abdomen.

Study summary

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Pregnant persons age 18-45 years 2. Single intrauterine pregnancy 3. Gestational duration: 18 - 28 weeks Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Pregnant individuals with multi-fetal gestation (e.g., twins, triplets, etc.). 2. Pregnant individuals with suspected or known fetal anomaly, undergoing evaluation for genetic abnormality, requiring non-standard care, or diagnostic intervention. 3. 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 4. Patients with serious medical comorbidities including: maternal congenital heart abnormalities; history of organ transplant; asthma exacerbation (during pregnancy); pre-eclampsia; recent mechanical trauma. 5. Use of any of the following during pregnancy: marijuana (or similar derivatives); alcohol; tobacco; methamphetamines; warfarin; isotretinoin; methotrexate; valproic acid; retinoids; oral steroids 6. Non-English speaking. 7. Participants deemed unsuitable by the investigator due to safety or data integrity.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
OHSU Perinatology and Genetics Clinic Portland Oregon

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07590063 on ClinicalTrials.gov ↗ ← All trials in the USA