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NC Thermometer (Gen 3) ISO 80601-2-56 Validation

NCT05721131 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 105

Last updated 2023-10-30

No results posted yet for this study

Summary

The purpose of this clinical validation is to evaluate the the clinical bias, the limits of agreement, and the clinical repeatability of measuring oral temperature using a new thermometer, NC° Thermometer (Gen 3), compared to a reference clinical thermometer.

Conditions

  • Febrile Illness
  • Healthy
  • Fever

Interventions

DEVICE

NC° Thermometer (Gen 3)

The NC° Thermometer (Gen3) is used orally for the intermittent measurement and monitoring of human body temperature. The device can be used by adults and children over the age of 5 years old.

Sponsors & Collaborators

  • Natural Cycles

    lead INDUSTRY

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-10
Primary Completion
2023-04-27
Completion
2023-04-27
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05721131 on ClinicalTrials.gov