Clinical Performance of Masimo Rad-GT

NCT ID: NCT05779397

Last Updated: 2023-07-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2023-02-23

Brief Summary

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

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 (NCT05779397, NCT05787782, and NCT05674344).

Conditions

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Healthy

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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Test Subject

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

Group Type EXPERIMENTAL

Masimo RAD-GT

Intervention Type DEVICE

Non-contact infrared thermometry device

Interventions

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Masimo RAD-GT

Non-contact infrared thermometry device

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Masimo Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Masimo Corporation

Irvine, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://clinicaltrials.gov/ct2/show/NCT05787782?term=koei0004&draw=2&rank=1

Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

https://clinicaltrials.gov/ct2/show/NCT05674344?term=choc0008&draw=2&rank=1

Calibration and Validation of the Masimo Temperature Device in Febrile Patients

Other Identifiers

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CIP-1064

Identifier Type: -

Identifier Source: org_study_id

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