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

Launched by NORBERT HEALTH · Nov 28, 2022

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Trial Information

Current as of February 05, 2025

Withdrawn

Keywords

Medical Device Validation Febrile Thermometer Body Temperature Norbert Device Norbert Health

ClinConnect Summary

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).

Gender

ALL

Eligibility criteria

  • 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

About Norbert Health

Norbert Health is a forward-thinking clinical trial sponsor dedicated to advancing healthcare through innovative research and development. With a focus on leveraging cutting-edge technologies and methodologies, Norbert Health aims to streamline the clinical trial process, ensuring efficiency and accuracy in data collection and analysis. Committed to enhancing patient outcomes, the organization collaborates with a diverse range of stakeholders, including healthcare providers and regulatory bodies, to facilitate the successful development of new therapies and medical interventions. Through its comprehensive approach and dedication to excellence, Norbert Health strives to contribute significantly to the evolution of clinical research and the improvement of global health standards.

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