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Trans-abdominal Fetal Pulse Oximetry

NCT05147584 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-02-04

Study results available
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Summary

The Raydiant Oximetry Sensing System (Lumerah) is a non-invasive fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. Lumerah is intended as an adjunct to cardiotocography by detecting decreases in fetal oxygenation.

Conditions

  • Fetal Hypoxia
  • Fetal Distress
  • Fetal Acidemia
  • Fetal or Neonatal Effect of Complication of Labor

Interventions

DEVICE

Dual fetal oxygen sensors

Placement of both internal and external fetal oxygen sensors

Sponsors & Collaborators

  • Raydiant Oximetry, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Rosen, MD · Raydiant Oximetry

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2023-11-29
Completion
2023-11-29
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 NCT05147584 on ClinicalTrials.gov