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OpenTrials
Completed

NCT Number: NCT05779397

Clinical Performance of Masimo Rad-GT

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Masimo Corporation

Irvine, California, 92618, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Masimo RAD-GT

Device

Non-contact infrared thermometry device

Primary outcomes

  1. Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 22, 2023
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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