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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 - up to 1 month | Age group 0 up to 1 month | ||
| A2 - 1 to 3 months | Age group from 1 month to 3 months | ||
| A3 - 3 months to 1 year | Age group from 3 months to 1 year | ||
| B - 1 year to 5 years | Age group from older than 1y and younger than 5 years | ||
| C - 5 years to 12 years | Age group from older than 5y and younger than 12 years | ||
| D - 12 years to 21 years | Age group from older than 12 years and younger than 21 years | ||
| E - 21 years and older | Age group older than 21 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Temperature Agreement in Degrees Celsius. | Temperature Agreement/Bias (Zero heat flux thermometry temperature minus oral or rectal temperature) between simultaneously-acquired oral or rectal and forehead deep tissue temperatures. | Upon enrollment |
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Inclusion Criteria:
-
Exclusion Criteria:
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120 subjects of any racial, gender, or ethnic background in who simultaneous measurments of deep tissue, oral, or rectal temperature can be made
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| Name | Affiliation | Role |
|---|---|---|
| Daniel i Sessler, MD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
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| Label | URL |
|---|---|
| Outcomes Research Consortium | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Age 1 | Age group 0 up to 1 month |
| FG001 | Age 2 | Age group from 1 month to 3 months |
| FG002 | Age 3 | Age group from 3 months to 1 year |
| FG003 | Age 4 | Age group from older than 1y and younger than 5 years |
| FG004 | Age 5 | Age group from older than 5y and younger than 12 years |
| FG005 | Age 6 | Age group from older than 12 years and younger than 21 years |
| FG006 | Age 7 | Age group older than 21 years |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Age1 | Age group 0 up to 1 month |
| BG001 | Age2 | Age group from 1 month to 3 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Temperature Agreement in Degrees Celsius. | Temperature Agreement/Bias (Zero heat flux thermometry temperature minus oral or rectal temperature) between simultaneously-acquired oral or rectal and forehead deep tissue temperatures. | Posted | Mean | Standard Deviation | Temperature in Celsius | Upon enrollment |
|
Immediately upon enrollment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Age1 | Age group 0 up to 1 month | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Terri White | 3M | 651-733-0228 | twhite3@mmm.com |
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| BG002 |
| Age3 |
Age group from 3 months to 1 year |
| BG003 | Age4 | Age group from older than 1y and younger than 5 years |
| BG004 | Age5 | Age group from older than 5y and younger than 12 years |
| BG005 | Age6 | Age group from older than 12 years and younger than 21 years |
| BG006 | Age7 | Age group older than 21 years |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG003 | Age4 | Age group from older than 1y and younger than 5 years |
| OG004 | Age5 | Age group from older than 5y and younger than 12 years |
| OG005 | Age6 | Age group from older than 12 years and younger than 21 years |
| OG006 | Age7 | Age group older than 21 years |
|
|
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Age2 | Age group from 1 month to 3 months | 0 | 10 | 0 | 10 | 0 | 10 |
| EG002 | Age3 | Age group from 3 months to 1 year | 0 | 10 | 0 | 10 | 0 | 10 |
| EG003 | Age4 | Age group from older than 1y and younger than 5 years | 0 | 30 | 0 | 30 | 0 | 30 |
| EG004 | Age5 | Age group from older than 5y and younger than 12 years | 0 | 20 | 0 | 20 | 0 | 20 |
| EG005 | Age6 | Age group from older than 12 years and younger than 21 years | 0 | 20 | 0 | 20 | 0 | 20 |
| EG006 | Age7 | Age group older than 21 years | 0 | 20 | 0 | 20 | 0 | 20 |
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