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NCT03134326 · ClinicalTrials.gov registry record · NA
Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence
A NA study, sponsored by Masimo Corporation.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT03134326: Completed NA study, sponsored by Masimo Corporation.
NCT03134326 is a NA study that has completed, run by Masimo Corporation. The registered enrollment target is 21 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
NCT03134326, a NA study, has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study Summary
In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 12-17 g/dL in the device's 8-17 g/dL specification range. The purpose of the study was to evaluate a change in the sensor component and to assess performance equivalence in the sub-range. The performance of non-invasive hemoglobin is not uniform across the accuracy range.
Primary Outcome
Sub-range performance equivalence was determined by comparing the noninvasive hemoglobin measurement of the pulse oximeter sensor to the hemoglobin value obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value. In order to obtain the Arms value, the blood sample hemoglobin value is subtracted from the pulse oximeter hemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of these differences
Interventions
- DEVICE R1-25 and R2-25 Pulse Oximeter Sensor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2009-06-18 |
| Est. Completion | 2009-07-02 |
| Phase | NA |
What the finished NCT03134326 record still lists
NCT03134326 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 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 1 intervention - of which R1-25 and R2-25 Pulse Oximeter Sensor is the first listed.
NCT03134326 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03134326 about?
NCT03134326 is a clinical study titled "Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence". In this study, the concentration of hemoglobin was measured using noninvasive pulse oximeter sensors and compared against the hemoglobin measurement from the subject's blood sample under controlled conditions. Data collected in the study was in the sub-range of 12-17 g/dL in the device's 8-17 g/dL s...
What is the current status of trial NCT03134326?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2009-06-18. Estimated completion is 2009-07-02.
What interventions are being tested in trial NCT03134326?
The interventions under investigation include: R1-25 and R2-25 Pulse Oximeter Sensor (DEVICE).
Who is sponsoring clinical trial NCT03134326?
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 NCT03134326's enrollment target sits among peer trials
21 1762nd of 2000 higher than 233 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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