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Thales Thermography Triage (3T) - Pilot Project

NCT04792450 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2021-03-11

No results posted yet for this study

Summary

COVID Related Study.

This study will compare the Thales High Temperature Detection (HTD) system with the two routinely used temperature measurement systems (tympanic and forehead) in patients and staff in the Emergency Department.

The aims of the study are:

* To determine the diagnostic accuracy of HTD for the measurement of fever, using an equivalence comparison with the maximum temperature recorded with two routinely used temperature measurements (tympanic and forehead), margin ±0.2°C.
* To determine if skin tone is an independent confounding factor in the measurement of fever using HTD
* To establish performance of internal calibration of Thales device
* To power for a definitive Clinical Investigation to determine clinical efficacy and safety cut off with HTD If results are encouraging the aim would then be to undertake a clinical investigation in order to get CE marking for use in a clinical setting.

Conditions

Interventions

DEVICE

Thermography

Measure Temperature using Thermal Camera

DEVICE

Tympanic Thermometer

Measure Temperature using Tympanic Thermometer

DEVICE

Forehead Thermometer

Measure Temperature using Forehead Temperature

DEVICE

62 Max + Infra-red thermometer

Measure Temperature using 62 Max + Infra-red thermometer

Sponsors & Collaborators

  • Thales Group

    collaborator UNKNOWN

  • NHS Greater Clyde and Glasgow

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-01
Primary Completion
2020-12-15
Completion
2021-05-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT04792450 on ClinicalTrials.gov