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NCT03157232 · ClinicalTrials.gov registry record · NA
Rainbow DCI vs. R1-25 Sensor SpHb Sub-Range Performance Equivalence
A NA study, sponsored by Masimo Corporation.
- Completed
- Registry status
- NA
- Development phase
- 18
- Enrollment target
NCT03157232 is a NA study that has completed, run by Masimo Corporation. The registered enrollment target is 18 participants.
The verdict
NCT03157232, a NA study, has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 18 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 11-17 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 Rainbow DCI and R1-25 sensor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2009-06-19 |
| Est. Completion | 2009-06-29 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03157232
The ClinicalTrials.gov registry entry for NCT03157232 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 18 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 Rainbow DCI and R1-25 sensor is the first listed.
NCT03157232 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03157232 about?
NCT03157232 is a clinical study titled "Rainbow DCI vs. R1-25 Sensor 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 11-17 g/dL in the device's 8-17 g/dL s...
What is the current status of trial NCT03157232?
This trial is currently completed. It is a NA study. The enrollment target is 18 participants. The study started on 2009-06-19. Estimated completion is 2009-06-29.
What interventions are being tested in trial NCT03157232?
The interventions under investigation include: Rainbow DCI and R1-25 sensor (DEVICE).
Who is sponsoring clinical trial NCT03157232?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
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