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Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children

NCT03123354 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2018-06-13

Study results available
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Summary

The study will collect cerebral oximetry data from pediatric and neonatal subjects using the Masimo O3 regional oximetry device, for the purposes of device calibration and validation.

Conditions

  • Surgery

Interventions

DEVICE

O3 regional oximeter sensor

Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor

Sponsors & Collaborators

  • Masimo Corporation

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-01
Primary Completion
2017-03-13
Completion
2017-03-13
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 NCT03123354 on ClinicalTrials.gov