Trials / Completed
CompletedNCT02930850
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 447 (actual)
- Sponsor
- Masimo Corporation · Industry
- Sex
- All
- Age
- 1 Month
- Healthy volunteers
- Accepted
Summary
The purpose study is to report on the accuracy of noninvasive hemoglobin (SpHb) as compared to hemoglobin measurements obtained from a laboratory hematology analyzer.
Detailed description
The primary objective of this clinical investigation is to report on the accuracy of the Rad-67 and DCI Mini sensor to measure SpHb as compared to hemoglobin measurements obtained from a manual HiCN analytical method and automated Beckman Coulter laboratory hematology analyzers.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Rad-67 Pulse oximeter | Noninvasive pulse oximeter that measures hemoglobin |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2016-10-01
- Completion
- 2016-10-01
- First posted
- 2016-10-12
- Last updated
- 2019-04-08
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02930850. Inclusion in this directory is not an endorsement.