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

Sponsor

Norbert Health (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05640310

Collaborator

Northwell Health (Other)

105

Enrollment

1.9

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Febrile Illness	Device: Norbert Device

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 Design

Study Type:

Observational

Anticipated Enrollment :

105 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Mar 1, 2023

Outcome Measures

Primary Outcome Measures

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.
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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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