Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-23

Study Completion Date

2023-03-02

Brief Summary

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

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Detailed Description

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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).

Conditions

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Fever

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Masimo INVSENSOR00063

All subjects are enrolled into this arm and will have temperature measurements obtained.

Group Type EXPERIMENTAL

Masimo INVSENSOR00063

Intervention Type DEVICE

Masimo INVSENSOR00063 will be used to measure temperature

Interventions

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Masimo INVSENSOR00063

Masimo INVSENSOR00063 will be used to measure temperature

Intervention Type DEVICE

Eligibility Criteria

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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