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

NCT04876846 | Completed FDA Device

• 1 other identifier: GEN 3
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fetal Hypoxia

Outcome Measures

Primary Outcomes (1)

• Fetal Signal

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

  After 36 weeks of pregnancy

Study Arms (1)

Interventional/Observational

EXPERIMENTAL

The Gen 3 device will be positioned on the maternal abdomen to measure light scattering and absorption for a period of about 10-20 minutes. A second measurement may be obtained for a total of up to 40 minutes. Subject's end their participation in the study after that time period.

Device: GEN 3 Monitoring of Fetus

Interventions

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

Interventional/Observational

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Raydiant Oximetry, Inc.: lead

Study Sites (1)

Yaron Friedman, MD, Inc.

Walnut Creek, California, 94598, United States

Location

MeSH Terms

Conditions

Fetal Hypoxia

Condition Hierarchy (Ancestors)

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

Study Officials

• Mark Rosen, MD

  Raydiant Oximetry

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: May 7, 2021
• Study Start: April 24, 2021
• Primary Completion: November 11, 2025
• Study Completion: November 11, 2025
• Last Updated: November 13, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)