Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation of INVSENSOR00026

NCT03610269 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 143

Last updated 2019-06-25

Study results available
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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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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03610269 on ClinicalTrials.gov