NCT06405984

Trans-Abdominal Fetal Pulse Oximetry - EFS-IDE

Trans-Abdominal Fetal Pulse Oximetry - An Early Feasibility Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Raydiant Oximetry, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a prospective, interventional, open-label, Early Feasibility Study Investigational Device Exemption (EFS-IDE). The Principal Investigator or research team member will consult a list of eligible patients based on predicted delivery dates and scheduled inductions. Women who are planning to undergo labor will be approached regarding this study. The study involves measurement of the fetal pulse signal with the investigational device, Lumerah, during labor. Lumerah is an investigational fetal pulse oximeter that measures fetal arterial oxygen saturation using safe, non-invasive, transabdominal near-infrared spectroscopy. The Lumerah device is intended as an adjunct to cardiotocography by detecting fetal oxygen deprivation that is both life-threatening to the fetus and can lead to the irreversibly debilitating consequences of newborn metabolic acidosis. The subjects will first undergo sonographic evaluation to assess distance from maternal skin to fetal tissue and to confirm fetal presentation and position during labor. The results of the sonographic measurements might influence the enrollment suitability of the subject as well as the placement of the Investigational device. The Oxiplex TS device, a non-ionizing laser system that provides researchers with valuable information regarding maternal optical tissue properties, will also be used. Once the membranes are ruptured, the investigator's team will use a Nellcor N-400 System with a sterile, single-use transvaginal sensor for data collection only. The outcomes of the fetal oxygenation measurements are masked; only the Sponsor is aware of the measurements. Therefore, no clinical decisions will be made based on the information derived from any of the devices used in this study.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-15
• Primary completion: 2025-10-17
• Completion: 2025-10-17
• First posted: 2024-05-09
• Last updated: 2025-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study