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Principles and Test Methods of Non-contact Body Thermometry

NCT05247736 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 110

Last updated 2022-02-21

No results posted yet for this study

Summary

Long-wavelength infrared (IR) detectors have a more than 20-year history in medical thermometry and have been used widely for febrile screening. However, over the past year and a half, public health entities, medical professionals, and the general public have begun to question the claimed accuracy of non-contact body thermometry. The standard assessment of a device's performance relies on clinical testing with febrile individuals, yet this practice may have inadvertently allowed the approval of IR systems that are unable to detect moderate fevers. The ability to test device performance without relying on febrile test participants would have important ramifications for public health, especially if this test discovered undisclosed differences in accuracy in widely used devices.

The aim is to examine the effect of the local environment and the physiology of the human body on the relationship between core body temperature and inner canthi (region near tear duct) skin temperature measured using non-contact thermal imaging and to use of this relationship to test actual device performance at detecting simulated elevated temperatures, without requiring volunteers having actual elevated temperatures. The overall goal of this research study is to validate and improve the science of non-contact core body temperature measurement.

Conditions

  • Thermometry

Interventions

DIAGNOSTIC_TEST

Infrared Thermography

Non-contact body thermometry

Sponsors & Collaborators

  • Thermal Diagnostics LLC

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-22
Primary Completion
2022-05-15
Completion
2022-05-15
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05247736 on ClinicalTrials.gov