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

NCT04876846 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-11-13

No results posted yet for this study

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

Interventions

DEVICE

GEN 3 Monitoring of Fetus

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

Sponsors & Collaborators

  • Raydiant Oximetry, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Rosen, MD · Raydiant Oximetry

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-24
Primary Completion
2025-11-11
Completion
2025-11-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04876846 on ClinicalTrials.gov