Clinical Performance of Masimo Rad-GT

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Device: Masimo RAD-GT

• Registration Number: NCT05779397
• Lead Sponsor: Masimo Corporation

Brief Summary

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

Detailed 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).

Study Timeline

• Study Start: 2023-02-20
• Primary Completion: 2023-02-23
• Study Completion: 2023-02-23
• Study First Submitted: 2023-03-09
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-22
• Results First Submitted: 2023-05-11
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-30
• Last Update Submitted: 2023-06-30
• Results First Posted: 2023-07-25
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Test Subject	Masimo RAD-GT	All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo RAD-GT

Primary Outcome Measures

Name	Time	Method
Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius)	1-3 hours	The accuracy of the Masimo Rad-GT sensor will be determined by calculating the clinical bias (Δcb), limits of agreement (LA), and repeatability (σr). The temperature measurements from Masimo Rad-GT will be compared to the reference temperature measurements (Degrees Celsius).

Trial Locations

Locations (1)

Masimo Corporation; 🇺🇸 Irvine, California, United States