Comparison Study of Core Temperature Thermometry Systems

3M Company

Status: Completed

Conditions: Thermometry Device Comparisons

Study type: Observational

Funder types: Industry

Identifiers

NCT01255865

Arizant 10-1026

Details and patient eligibility

About

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

Full description

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.

Enrollment: 111 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

111 participants in 7 patient groups

A1 - up to 1 month

Description:

Age group 0 up to 1 month

A2 - 1 to 3 months

Description:

Age group from 1 month to 3 months

A3 - 3 months to 1 year

Description:

Age group from 3 months to 1 year

B - 1 year to 5 years

Description:

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

C - 5 years to 12 years

Description:

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

D - 12 years to 21 years

Description:

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

E - 21 years and older

Description:

Age group older than 21 years