Comparison Study of Core Temperature Thermometry Systems

3M111 enrolled

Overview

The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA.

The purpose of this trial is the generation of clinical data required for a 510(k) submission to the FDA. The trial design reflects elements desired by the FDA. The trial is designed to satisfy the relevant requirements of the FDA Guidance (March 1993) on the content of premarket notification \[510(k)\] submissions for clinical electronic thermometers and ISO/IEC 80601-2-56 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.

Study Type

OBSERVATIONAL

Enrollment

111

Conditions

Thermometry Device Comparisons

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: \- Exclusion Criteria: * Subjects with skin disruptions on the forehead, dysautonomia, spinal cord injury, or taking barbiturates, thyroid preparations, antipsychotics, or who have had a recent (1wk) immunization

Locations (1)

Cleveland Clinic

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Temperature Agreement in Degrees Celsius.

Temperature Agreement/Bias (Zero heat flux thermometry temperature minus oral or rectal temperature) between simultaneously-acquired oral or rectal and forehead deep tissue temperatures.

Time frame: Upon enrollment

Data from ClinicalTrials.gov

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