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

Withdrawn

• Conditions: Healthy; Febrile Illness

• Registration Number: NCT05640310
• Lead Sponsor: Norbert Health

Brief Summary

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

Detailed 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 Timeline

• Study First Submitted: 2022-11-28
• Study First Submitted QC: 2022-11-28
• Study First Posted: 2022-12-07
• Study Start: 2023-03
• Primary Completion: 2023-07
• Study Completion: 2023-07
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Bias	Up to 1 hour	Clinical Bias will be evaluated by comparing the first recorded measurement using ND with the corresponding measurement recorded by the RCT. The bias is calculated per IEC 80601-2-56, Clause 201.103.3.
Clinical Repeatability	Up to 1 hour	Clinical Repeatability is calculated by a pooled standard deviation of the triplicate measurements over the entire population of subjects. The method to calculate Clinical Repeatability is per IEC 80601-2-56, Clause 201.102.5.
Limits of Agreement	Up to 1 hour	Limits of Agreement (LOA) will be calculated using all three measurements by the ND and the corresponding measurements by the RCT. The LOA is calculated per IEC 80601-2-56, Clause 201.103.4.