Technology Development of Diagnostic Ultrasound System for Obstetric Imaging

NCT07590063 | Not Yet Recruiting FDA Device

• 2 other identifiers: UIH-OB-US-2026-001IRB 29935
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Complete Fetal Biometric Image Set Collection

  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

  Day 1

Secondary Outcomes (2)

• Reference Dataset Creation

  Within 4 months of study completion

• Incidence of Adverse Events

  Throughout study participation, up to 4 months

Study Arms (1)

Pregnant Participants

Pregnant persons aged 18-45 years with single intrauterine pregnancy at 18-28 weeks of gestational age undergoing obstetric ultrasound at OHSU

Device: Diagnostic Ultrasound System

Interventions

Diagnostic Ultrasound System DEVICE

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

Also known as: UIH uSONIQUE

Pregnant Participants

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant persons aged 18-45 years with single intrauterine pregnancy at 18-28 weeks gestational age presenting for obstetric care at Oregon Health \& Science University, Portland, Oregon

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.

Sponsors & Collaborators

• United Imaging Healthcare North America, Inc.: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

OHSU Perinatology and Genetics Clinic

Portland, Oregon, 97239, United States

Location

Central Study Contacts

Adam Principal Investigator, MD, MPH

CONTACT

503-494-6852; crosland@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 15, 2026
• Study Start: May 6, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)