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Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE

NCT06405984 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-10-21

No results posted yet for this study

Summary

The Lumerah System, developed and manufactured by Raydiant Oximetry, Inc., is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah System is intended as an adjunct to cardiotocography. In this study, women in labor will also be simultaneously monitored with a re-engineered version of the previously approved transvaginal oximeter sensor connected to a Nellcor N-400 fetal oximetry monitor for the purposes of device development. The data obtained from the transabdominal sensor and the transvaginal sensor will be used for research purposes only and will not be used to guide or alter patient management.

Conditions

  • Fetal Hypoxia
  • Fetal Distress
  • Fetal Conditions
  • Fetal Complications
  • Labor Fetal Anoxia
  • Labor (Obstetrics)--Complications
  • Oxygen Deficiency

Interventions

DEVICE

Fetal Oxygenation Measurements

The Lumerah device, and Oxiplex ISS will be positioned on the maternal abdomen in various locations depending on the sonographic evaluation. The transvaginal sensor will be placed after rupture of the maternal membranes and appropriate descent of the fetus.This study is for data collection purposes only. Neonates of this study arm will also be monitored with the Oxiplex ISS system. This study is for data collection purposes only.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Raydiant Oximetry, Inc.

    lead INDUSTRY

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
2024-04-15
Primary Completion
2025-10-17
Completion
2025-10-17
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT06405984 on ClinicalTrials.gov