Trans-abdominal Fetal Pulse Oximetry; Tissue Light Scattering and Signal Integrity

The overall purpose of this study is to evaluate maternal-fetal tissue light scattering properties. The objectives of the study are: (i) integrate established mathematical principles of oxygen saturation to model with increasing accuracy the "body in a body" problem of fetus in mother; similar to existing pulse oximeters, the calculations will be integrated into software in the final commercial product; (ii) obtain human measurements against which both computational models and animal data can be compared.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fetal Hypoxia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Hypoxia Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Signs and Symptoms, Respiratory Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Yaron Friedman, MD, Inc.

Walnut Creek, California, 94598, United States

About this study

This is a prospective, observational, non-significant risk study. The study involves using non-invasive devices that measure fetal depth and tissue light scattering on the maternal abdomen. Ultrasound assessment will be performed, and multiple images taken at various locations on the abdomen. All images will be captured with minimal probe pressure applied to allow accurate ascertainment of depth. Images will be anonymized, and all study data will be coded with a unique identifier. Key maternal descriptive statistics will be recorded from the medical record including BMI, height, weight (kg), parity, age and gestational age.

The ISS device is a customized commercial frequency domain oximeter (Imagent, ISS Inc.; http://www.iss.com/biomedical/instruments/imagent.html) with multiple laser sources and multiple detectors. This instrument is safe, uses non-ionizing radiation.

The Raydiant Lumerah device is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah device will be positioned on the maternal abdomen of women volunteers in the late 3rd trimester.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women with singleton, healthy pregnancy at gestational age ≥ 36 weeks
Age > 18 years
Willing to come in for testing outside of routine business hours (including Saturdays)

Exclusion criteria

Age <18
Multiple gestation (twins, triplets)
Presentation other than vertex or breech
< 36 weeks of gestation

Treatment and study plan

GEN 3 Monitoring of Fetus

Device

Measurement of tissue light scatter in the "body in body" during late term pregnancy and evaluation of signal integrity

Primary outcomes

Fetal Signal

Time frame: After 36 weeks of pregnancy

Correlation of the fetal doppler signal with the ROSS device optional fetal signal.

Sponsors and collaborators

Lead sponsor

Raydiant Oximetry, Inc.

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: May 7, 2021
Registry last updated: Nov 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed