Comparison Study of Core Temperature Thermometry Systems

NCT ID: NCT01255865

Last Updated: 2020-08-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Thermometry Device Comparisons

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

OTHER

Study Groups

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A1 - up to 1 month

Age group 0 up to 1 month

No interventions assigned to this group

A2 - 1 to 3 months

Age group from 1 month to 3 months

No interventions assigned to this group

A3 - 3 months to 1 year

Age group from 3 months to 1 year

No interventions assigned to this group

B - 1 year to 5 years

Age group from older than 1y and younger than 5 years

No interventions assigned to this group

C - 5 years to 12 years

Age group from older than 5y and younger than 12 years

No interventions assigned to this group

D - 12 years to 21 years

Age group from older than 12 years and younger than 21 years

No interventions assigned to this group

E - 21 years and older

Age group older than 21 years

No interventions assigned to this group

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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3M

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel i Sessler, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Related Links

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http://www.or.org

Outcomes Research Consortium

Other Identifiers

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Arizant 10-1026

Identifier Type: -

Identifier Source: org_study_id

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