MedTrace Logo

Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates

NCT03828487 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2021-06-07

Study results available
· View outcomes & findings →

Summary

The aim of the study is to compare the performance of the O3 cerebral oximeter and sensor to a 510(k) cleared NIRS (Near-Infrared Spectroscopy) device on neonatal subjects based on data collected from the cutaneously placed forehead sensors. Due to the design of the systems, the devices will be used serially instead of concurrently. Because of this timing, changes in patient state may not be reflected in measurements collected by both devices.

Conditions

  • Regional Saturation of Oxygen (rSO2)

Interventions

DEVICE

Masimo O3 Neonatal Sensors

Regional Oximetry sensor for Neonates

DEVICE

510(k) cleared sensor

Cleared Regional Oximetry sensor for Neonates

Sponsors & Collaborators

  • Masimo Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-12-19
Primary Completion
2019-06-14
Completion
2019-06-14
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 NCT03828487 on ClinicalTrials.gov