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Comparison Study of Core Temperature Thermometry Systems

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ClinicalTrials.gov Identifier: NCT01255865
Recruitment Status : Unknown
Verified June 2011 by Arizant Healthcare.
Recruitment status was:  Enrolling by invitation
First Posted : December 8, 2010
Last Update Posted : July 1, 2011
Sponsor:
Information provided by:
Arizant Healthcare

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

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

Group/Cohort
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




Information from the National Library of Medicine

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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT01255865


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

Additional Information:
Responsible Party: Daniel Sessler, MD, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT01255865     History of Changes
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 Arizant Healthcare:
Thermometry
Deep Tissue Temperature
Core Temperature
Body Temperature
Rectal Temperature
Oral Temperature