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NCT05779397 Clinical Trial

Clinical Performance of Masimo Rad-GT

Healthy Clinical Trial

Official title:
Clinical Performance of Masimo Rad-GT

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05779397
Other study ID # CIP-1064
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 20, 2023
Est. completion date February 23, 2023

Study information
Verified date June 2023
Source Masimo Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is designed to validate the clinical performance of Masimo Rad-GT in the accuracy of temperature measurements.

Description:

Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05779397, NCT05787782, and NCT05674344).

Recruitment information / eligibility
Status Completed
Enrollment 68
Est. completion date February 23, 2023
Est. primary completion date February 23, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - Subject is 18 to 80 years of age. - Subjects are able to read and communicate in English as well as understand the study and the risks involved. Exclusion Criteria: - Subject is pregnant or nursing. - Subject has a known neurological and/or psychiatric disorder (e.g., schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subject's level of consciousness. * - Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff. (* = Per study staff discretion)

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Masimo RAD-GT
Non-contact infrared thermometry device

Locations
Country Name City State
United States Masimo Corporation Irvine California

Sponsors (1)
Lead Sponsor Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius) The accuracy of the Masimo Rad-GT sensor will be determined by calculating the clinical bias (?cb), limits of agreement (LA), and repeatability (sr). The temperature measurements from Masimo Rad-GT will be compared to the reference temperature measurements (Degrees Celsius). 1-3 hours
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