Prospective Study to Validate the Clinical Accuracy of Norbert Device to Measure Body Temperature

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-31

Study Completion Date

2023-07-31

Brief Summary

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The study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND).

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Detailed Description

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The study design is based on the ISO 80601-2-56, Clause 201.102 for adjusted mode clinical thermometers. The study is designed to be a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's temperature measurement compared to a standard FDA 510(k)-cleared reference clinical thermometer (RCT).

Conditions

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Healthy Febrile Illness

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Norbert Device

The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects over 22 years of age
* Ability to provide signed informed consent, and/or have a legally authorized representative (LAR) willing to provide informed consent on behalf of the subject
* ESI score of 3-5

Exclusion Criteria

* Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the study procedure
* Recent immunization within seven days of the study procedure
* Pregnancy
* ESI score of 1-2

Minimum Eligible Age

22 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes