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OpenTrials
Completed

NCT Number: NCT05787782

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.

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Key information

Conditions

Fever Body Temperature Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ascada Research

Fullerton, California, 92835, 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 (NCT05787782, NCT05674344 and NCT05779397).

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Masimo INVSENSOR00063

Device

Masimo INVSENSOR00063 will be used to measure temperature

Primary outcomes

  1. Accuracy of Temperature Measurements Using Masimo INVSENSOR00063

    Time frame: About 15-30 minutes

    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.

Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 28, 2023
Registry last updated
Oct 31, 2025

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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