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OpenTrials
Completed

NCT Number: NCT01255865

Comparison Study of Core Temperature Thermometry Systems

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

Completed

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Key information

Conditions

Thermometry Device Comparisons

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Temperature Agreement in Degrees Celsius.

    Time frame: Upon enrollment

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

Sponsors and collaborators

Lead sponsor

3M

Industry

Registry information

Official study title

Deep Tissue Thermometry 510(k) Premarket Notification Trial

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 8, 2010
Registry last updated
Aug 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.