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NCT03123354 · ClinicalTrials.gov registry record · NA
Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children
A NA study of Surgery, sponsored by Masimo Corporation.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
- 1
- Study location
NCT03123354: Completed NA study of Surgery, sponsored by Masimo Corporation.
NCT03123354 is a NA study of Surgery that has completed, run by Masimo Corporation. The registered enrollment target is 44 participants, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03123354, a NA study of Surgery, has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The continuous measurements of regional oxygen saturation (rSO2) was compared against its reference cerebral oxygen saturation which is measured by a combination of arterial and jugular venous blood oxygen saturation. Absolute accuracy was determined by the root-mean-squared error (Arms). The Arms error value is calculated as the square root of the sum of the squares of mean bias and estimated standard deviation of bias. The bias is defined as the difference of the rSO2 and its blood reference.
Conditions Studied
Interventions
- DEVICE O3 regional oximeter sensor
Study Locations (1)
California
- Stanford University - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2015-05-01 |
| Est. Completion | 2017-03-13 |
| Phase | NA |
What the finished NCT03123354 record still lists
NCT03123354 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Surgery appearing as the primary indexed condition, and to 1 intervention - of which O3 regional oximeter sensor is the first listed.
NCT03123354 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03123354 about?
NCT03123354 is a clinical study titled "Calibration and Validation of Masimo's O3 Regional Oximetry Device in Neonates, Infants and Children". 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.
What is the current status of trial NCT03123354?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2015-05-01. Estimated completion is 2017-03-13.
What conditions does trial NCT03123354 study?
This clinical trial studies the following conditions: Surgery.
What interventions are being tested in trial NCT03123354?
The interventions under investigation include: O3 regional oximeter sensor (DEVICE).
Who is sponsoring clinical trial NCT03123354?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03123354 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03123354's enrollment target sits among peer trials
44 96th of 120 higher than 25 of 120 other Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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