Comparison Study of Core Temperature Thermometry Systems

Deep Tissue Thermometry 510(k) Premarket Notification Trial

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

Study Overview

• Status: Completed
• Conditions: Thermometry Device Comparisons

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 Type: Observational
• Enrollment (Actual): 111

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

120 subjects of any racial, gender, or ethnic background in who simultaneous measurments of deep tissue, oral, or rectal temperature can be made

Description

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 Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
A1 - up to 1 month; Age group 0 up to 1 month
A2 - 1 to 3 months; Age group from 1 month to 3 months
A3 - 3 months to 1 year; Age group from 3 months to 1 year
B - 1 year to 5 years; Age group from older than 1y and younger than 5 years
C - 5 years to 12 years; Age group from older than 5y and younger than 12 years
D - 12 years to 21 years; Age group from older than 12 years and younger than 21 years
E - 21 years and older; Age group older than 21 years

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Upon enrollment

Collaborators and Investigators

• Sponsor: 3M
• Investigators: Principal Investigator: Daniel I Sessler, MD, The Cleveland Clinic

Publications and helpful links

Helpful Links

• Outcomes Research Consortium

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: December 6, 2010
• First Submitted That Met QC Criteria: December 6, 2010
• First Posted (Estimate): December 8, 2010

Study Record Updates

• Last Update Posted (Actual): August 25, 2020
• Last Update Submitted That Met QC Criteria: August 12, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Body Temperature; Thermometry; Deep Tissue Temperature; Core Temperature; Rectal Temperature; Oral Temperature
• Other Study ID Numbers: Arizant 10-1026