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Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05640310
• Other study ID #: NCP-0001
• Status: Withdrawn
• Start date: March 2023
• Est. completion date: July 2023

Study information

• Verified date: August 2023
• Source: Norbert Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Febrile Illness
• Fever
• Healthy
• Hyperthermia

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Norbert Health	Northwell Health

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Bias	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.	Up to 1 hour
Primary	Limits of Agreement	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.	Up to 1 hour
Primary	Clinical Repeatability	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.	Up to 1 hour