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Comparison Study of Core Temperature Thermometry Systems

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01255865
Recruitment Status : Unknown
Verified June 2011 by 3M.
Recruitment status was:  Enrolling by invitation
First Posted : December 8, 2010
Last Update Posted : July 1, 2011
Information provided by:

Brief Summary:
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.

Condition or disease
Thermometry Device Comparisons

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Crossover
Official Title: Deep Tissue Thermometry 510(k) Premarket Notification Trial
Study Start Date : December 2010
Estimated Primary Completion Date : August 2011
Estimated Study Completion Date : August 2011

Age group 0 up to 1 month
Age group from 1 month to 3 months
Age group from 3 months to 1 year
Age group from older than 1y and younger than 5 years
Age group from older than 5y and younger than 12 years
Age group from older than 12 years and younger than 21 years
Age group older than 21 years

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01255865

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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Additional Information:
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Responsible Party: Daniel Sessler, MD, Cleveland Clinic Foundation Identifier: NCT01255865    
Other Study ID Numbers: Arizant 10-1026
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: July 1, 2011
Last Verified: June 2011
Keywords provided by 3M:
Deep Tissue Temperature
Core Temperature
Body Temperature
Rectal Temperature
Oral Temperature