Completed
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
What is being tested
Masimo Rad-67 Pulse Oximeter
Device
Who is being recruted
Anemia
+ Hematologic Diseases
+ Hemic and Lymphatic Diseases
Over 1 Months
+9 Eligibility Criteria
How is the trial designed
Other Study
Interventional
Study Start: April 2016
Summary
Principal SponsorMasimo Corporation
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 11, 2016
Actual date on which the first participant was enrolled.In this study, the accuracy of a noninvasive hemoglobin sensor(s) will be assessed by comparison to hemoglobin measurements from a laboratory analyzer.
Official TitleSpot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
Principal SponsorMasimo Corporation
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
368 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 1 Months
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
AnemiaHematologic DiseasesHemic and Lymphatic Diseases
Criteria
6 inclusion criteria required to participate
Male or female
Age: Greater than one month
Weight: Greater than or equal to 3kg
Any racial or ethnic group
Show More Criteria
3 exclusion criteria prevent from participating
Subjects with skin abnormalities at the planned application sites that may interfere with sensor application, per directions-for-use (DFU) or trans-illumination of the site, such as burns, scar tissue, nail polish, acrylic nails, infections, abnormalities, etc.
Subjects deemed not suitable for the study at the discretion of the investigator
Subjects unlikely to be able to refrain from excessive motion during data collection. Excessive motion includes postural changes, making hand gestures, involuntary muscular movements, etc.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalAll subjects are enrolled into the test group and receive Masimo Rad-67 Pulse Oximeter for measurement of hemoglobin.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center