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NCT03828487 · ClinicalTrials.gov registry record · NA
Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates
A NA study, sponsored by Masimo Corporation.
- Terminated
- Registry status
- NA
- Development phase
- 8
- Enrollment target
NCT03828487: Clinical Trial NA study, sponsored by Masimo Corporation.
NCT03828487 is a NA study that was terminated before completion, run by Masimo Corporation. The registered enrollment target is 8 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03828487, a NA study, was terminated before completion, sponsored by Masimo Corporation.
- TERMINATED
- Registry status
- NA
- Development phase
- 8 participants
- Enrollment target
Study 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.
Primary Outcome
In order to obtain the RMS value, rSO2 values collected from the control device (510(k) cleared regional oximetry sensor) is subtracted from the rSO2 values collected from the investigational device (Masimo O3 neonatal sensors) for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value.
Interventions
- DEVICE Masimo O3 Neonatal Sensors
- DEVICE 510(k) cleared sensor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2018-12-19 |
| Est. Completion | 2019-06-14 |
| Phase | NA |
Why NCT03828487 stopped before completion
NCT03828487 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Masimo O3 Neonatal Sensors is the first listed.
NCT03828487 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03828487 about?
NCT03828487 is a clinical study titled "Performance Comparison of Masimo O3 Regional Oximetry Sensors in Neonates". 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...
What is the current status of trial NCT03828487?
This trial is currently terminated. It is a NA study. The enrollment target is 8 participants. The study started on 2018-12-19. Estimated completion is 2019-06-14.
What interventions are being tested in trial NCT03828487?
The interventions under investigation include: Masimo O3 Neonatal Sensors (DEVICE), 510(k) cleared sensor (DEVICE).
Who is sponsoring clinical trial NCT03828487?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03828487's enrollment target sits among peer trials
8 1976th of 2000 higher than 19 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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