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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pregnancy
• Intervention / Treatment: Device: Diagnostic Ultrasound System

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Adam Principal Investigator, MD, MPH; Phone Number: 503-494-6852; Email: crosland@ohsu.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Perinatology and Genetics Clinic
      • Contact: Adam Crosland, MD, MPH; Phone Number: 503-494-6852; Email: crosland@ohsu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Investigational diagnostic ultrasound system used to perform fetal anatomic survey of the maternal abdomen.; Other Names: UIH uSONIQUE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reference Dataset Creation	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	Within 4 months of study completion
Incidence of Adverse Events	Nature, frequency, and severity of adverse events (AEs) and serious adverse events (SAEs), including device-related complications and study discontinuations	Throughout study participation, up to 4 months

Collaborators and Investigators

• Sponsor: United Imaging Healthcare North America, Inc.
• Collaborators: Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Estimated): May 6, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 9, 2026
• First Posted (Actual): May 15, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 9, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: UIH-OB-US-2026-001; IRB 29935 (Other Identifier: OHSU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This is a proprietary dataset for UIH's 510(k) submission and is not intended for public sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No