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Dual System Study: Transvaginal Fetal Pulse Oximetry Measurement Systems

NCT07296419 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-12-22

No results posted yet for this study

Summary

The objective of this study is to collect and compare fetal SpO2 waveforms and reference values to inform algorithm development for signal qualification and FSpO2 calculations. Subjects are women in labor.

Conditions

  • Fetal Hypoxia
  • Fetal Acidemia

Interventions

DEVICE

Fetal Pulse Oximetery

Two fetal pulse oximeter sensors are connected to two separate systems for development of the Raydiant fetal pulse oximeter algorithm.

Sponsors & Collaborators

  • Raydiant Oximetry, Inc.

    lead INDUSTRY

Principal Investigators

  • Perry S Barrilleaux, MD · Louisiana State University Health Shreveport

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2026-03-31
Completion
2026-04-30
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 NCT07296419 on ClinicalTrials.gov