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NCT05787782 Clinical Trial

Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

Fever Clinical Trial

Official title:
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05787782
Other study ID # KOEI0004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 23, 2023
Est. completion date March 2, 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

This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining 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 (NCT05787782, NCT05674344 and NCT05779397).

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date March 2, 2023
Est. primary completion date March 2, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Masimo INVSENSOR00063
Masimo INVSENSOR00063 will be used to measure temperature

Locations
Country Name City State
United States Ascada Research Fullerton 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 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
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