Comparison Study of Core Temperature Thermometry Systems

Completed

• Conditions: Thermometry Device Comparisons

• Registration Number: NCT01255865
• Lead Sponsor: 3M

Brief Summary

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

Detailed Description

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 Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-06
• Study First Posted: 2010-12-08
• Primary Completion: 2011-08
• Study Completion: 2011-12
• Results First Submitted: 2019-09-24
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-12
• Last Update Submitted: 2020-08-12
• Results First Posted: 2020-08-25
• Last Update Posted: 2020-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 111

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Temperature Agreement in Degrees Celsius.	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.

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States