Comparison Study of Core Temperature Thermometry Systems

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Arizant Healthcare
ClinicalTrials.gov Identifier:
NCT01255865
First received: December 6, 2010
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

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

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

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 ClinicalTrials.gov identifier: NCT01255865

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

Additional Information:
No publications provided

Responsible Party: Daniel Sessler, MD, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT01255865     History of Changes
Other Study ID Numbers: Arizant 10-1026
Study First Received: December 6, 2010
Last Updated: June 30, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Arizant Healthcare:
Thermometry
Deep Tissue Temperature
Core Temperature
Body Temperature
Rectal Temperature
Oral Temperature

ClinicalTrials.gov processed this record on August 01, 2014