Trials / Completed
CompletedNCT03134326
Rainbow R2-25 vs. R1-25 SpHb Sub-Range Performance Equivalence
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Masimo Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | R1-25 and R2-25 Pulse Oximeter Sensor |
Timeline
- Start date
- 2009-06-18
- Primary completion
- 2009-07-02
- Completion
- 2009-07-02
- First posted
- 2017-04-28
- Last updated
- 2017-07-27
- Results posted
- 2017-07-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03134326. Inclusion in this directory is not an endorsement.