Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining temperature measurements.

Study Overview

• Status: Completed
• Conditions: Fever
• Intervention / Treatment: Device: Masimo INVSENSOR00063

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 (NCT05787782, NCT05674344 and NCT05779397).

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Fullerton, California, United States, 92835
      • Ascada Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Participant age ≥ 1 year
• Afebrile or febrile at time of enrollment: For febrile subjects, ≥ 99.5 F/ 37.5 C for sublingual temperature reference; ≥ 100.4 F/ 38 C for temporal artery temperature reference.
• English-or Spanish-speaking patient or parent/Legal Guardian

Exclusion Criteria:

• Participants deemed not suitable for the study at the discretion of the investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Masimo INVSENSOR00063; All subjects are enrolled into this arm and will have temperature measurements obtained.	Device: Masimo INVSENSOR00063; Masimo INVSENSOR00063 will be used to measure temperature

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of Temperature Measurements Using Masimo INVSENSOR00063	Masimo INVSENSOR00063 temperature measurements will be compared to reference temperature measurements. Accuracy of Masimo INVSENSOR00063 will be measured using clinical bias, limits of agreement and repeatability.	About 15-30 minutes

Collaborators and Investigators

• Sponsor: Masimo Corporation

Publications and helpful links

Helpful Links

• Calibration and Validation of the Masimo Rad-G with Temperature device in Febrile Patients
• Clinical Performance of Masimo Rad-GT

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Actual): March 2, 2023
• Study Completion (Actual): March 2, 2023

Study Registration Dates

• First Submitted: March 15, 2023
• First Submitted That Met QC Criteria: March 15, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Estimated): October 31, 2025
• Last Update Submitted That Met QC Criteria: October 29, 2025
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Temperature Changes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Fever
• Other Study ID Numbers: KOEI0004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes