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Clinical Trial Summary

Fever is one of the key symptoms exhibited by contagious patients infected with the Ebola and other viruses. Thermographs and non-contact infrared thermometers (NCITs) are commonly used as early detection tools for screening and isolating sick individuals in healthcare settings and transit centers such as airports. The objective of this clinical study is to evaluate the temperature measurement accuracy of thermographs and NCITs. The study will be accomplished by establishing a protocol based on best practices for screening published in the IEC 80601-2-59:2008 Medical electrical equipment -- Part 2-59: Particular requirements for basic safety and essential performance of screening thermographs for human febrile temperature screening standard, performing initial measurements in patients to optimize clinical procedures, then performing quantitative clinical measurements in febrile and afebrile human subjects to compare thermographs - used in accordance with recognized best practices for measurement - with NCITs for fever screening. Since thermographs and NCITs represent the only currently viable mass screening approaches for infectious disease pandemics, like the recent Ebola virus disease (EVD) outbreak in West Africa, the study will evaluate these thermal modalities as medical countermeasures for fever-related pandemics and therefore improve response to these diseases.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04370743
Study type Observational
Source Food and Drug Administration (FDA)
Contact
Status Completed
Phase
Start date November 30, 2016
Completion date April 25, 2018

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