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

NCT05640310 | Withdrawn

• 1 other identifier: NCP-0001
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy; Febrile Illness

Keywords

medical device; validation; febrile; thermometer; body temperature; Norbert Device; Norbert Health

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Interventions

Norbert Device DEVICE

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

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted within an Emergency Department where each subject is assigned an Emergency Severity Index (ESI) score. Only subjects with ESI scores ranging from 3-5 will be recruited for the study to prevent intervening with standard patient care.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Norbert Health: lead
• Northwell Health: collaborator

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: December 7, 2022
• Study Start: March 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share