Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026
NCT03610269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143
Last updated 2019-06-25
Summary
The primary objective of this clinical investigation is to evaluate the accuracy of using Masimo's INVSENSOR00026 Pulse CO-Oximeter and Sensor to measure hemoglobin, as compared to hemoglobin measurements obtained from various lab analyzer(s) and point of care device(s).
Conditions
Interventions
- DEVICE
-
INVSENSOR00026 (Pulse CO-Oximeter and sensor)
Noninvasive Pulse CO-Oximeter and sensor that measures noninvasive hemoglobin (SpHb)
Sponsors & Collaborators
-
Masimo Corporation
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-08-01
- Primary Completion
- 2018-08-16
- Completion
- 2018-08-16
- FDA Device
- Yes
Countries
- United States
Study Locations
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