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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 is a NA study that has completed, run by Masimo Corporation. The registered enrollment target is 21 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03134326
The ClinicalTrials.gov registry entry for NCT03134326 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masimo Corporation, which has 96 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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