This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Comparison Study of Core Temperature Thermometry Systems

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2011 by Arizant Healthcare.
Recruitment status was:  Enrolling by invitation
Information provided by:
Arizant Healthcare Identifier:
First received: December 6, 2010
Last updated: June 30, 2011
Last verified: June 2011
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.

Thermometry Device Comparisons

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Official Title: Deep Tissue Thermometry 510(k) Premarket Notification Trial

Further study details as provided by Arizant Healthcare:

Estimated Enrollment: 120
Study Start Date: December 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
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


Ages Eligible for Study:   Child, Adult, Senior
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01255865

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Arizant Healthcare
  More Information

Additional Information:
Responsible Party: Daniel Sessler, MD, Cleveland Clinic Foundation Identifier: NCT01255865     History of Changes
Other Study ID Numbers: Arizant 10-1026
Study First Received: December 6, 2010
Last Updated: June 30, 2011

Keywords provided by Arizant Healthcare:
Deep Tissue Temperature
Core Temperature
Body Temperature
Rectal Temperature
Oral Temperature processed this record on June 22, 2017