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

Norbert Health

Status: Withdrawn

Conditions: Healthy; Febrile Illness

Treatments: Device: Norbert Device

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05640310

NCP-0001

Details and patient eligibility

About

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

Full 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).

Sex: All

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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