Technology Development of Diagnostic Ultrasound System for Obstetric Imaging

N/ANot Yet RecruitingNCT07590063

United Imaging Healthcare North America, Inc.50 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Pregnancy

Interventions

Diagnostic Ultrasound SystemDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

OHSU Perinatology and Genetics Clinic

Portland, Oregon, United States

Outcomes

Primary Outcomes

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

Time frame: Day 1

Secondary Outcomes

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

Time frame: 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

Time frame: Throughout study participation, up to 4 months

Central Contacts

Adam Principal Investigator, MD, MPH

CONTACT

503-494-6852 crosland@ohsu.edu

Data from ClinicalTrials.gov

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