Trials / Completed
CompletedNCT03123354
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children Undergoing Cardiac Catherization
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (actual)
- Sponsor
- Masimo Corporation · Industry
- Sex
- All
- Age
- 1 Day – 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | O3 regional oximeter sensor | Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor |
Timeline
- Start date
- 2015-05-01
- Primary completion
- 2017-03-13
- Completion
- 2017-03-13
- First posted
- 2017-04-21
- Last updated
- 2018-06-13
- Results posted
- 2018-06-13
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03123354. Inclusion in this directory is not an endorsement.