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

Healthy Clinical Trial

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

Clinical Trial Summary

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

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05640310
Study type Observational
Source Norbert Health
Contact
Status Withdrawn
Phase
Start date March 2023
Completion date July 2023
View Details
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