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The study is designed to validate the clinical performance of Masimo Rad-GT in the accuracy of temperature measurements.
Individual sites are only representative of a subset of the overall population, per ISO 80601-2-56:2017(Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement), and therefore clinical bias and limits of agreement should not be evaluated for the subsets. Publication of results should include repeatability from individual sites and the combined clinical bias and limits of agreement (NCT05779397, NCT05787782, and NCT05674344).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test Subject | Experimental | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo RAD-GT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo RAD-GT | Device | Non-contact infrared thermometry device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius) | The accuracy of the Masimo Rad-GT sensor will be determined by calculating the clinical bias (Δcb), limits of agreement (LA), and repeatability (σr). The temperature measurements from Masimo Rad-GT will be compared to the reference temperature measurements (Degrees Celsius). | 1-3 hours |
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Inclusion Criteria:
Exclusion Criteria:
(* = Per study staff discretion)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masimo Corporation | Irvine | California | 92618 | United States |
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| Label | URL |
|---|---|
| Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts | View source |
| Calibration and Validation of the Masimo Temperature Device in Febrile Patients | View source |
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Of the 68 enrolled participants, 68 completed the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Rad-GT | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo RAD-GT Masimo RAD-GT: Non-contact infrared thermometry device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rad-GT | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo RAD-GT Masimo RAD-GT: Non-contact infrared thermometry device |
| 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 | Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius) | The accuracy of the Masimo Rad-GT sensor will be determined by calculating the clinical bias (Δcb), limits of agreement (LA), and repeatability (σr). The temperature measurements from Masimo Rad-GT will be compared to the reference temperature measurements (Degrees Celsius). | Data for 7 subjects was excluded as they did not complete at least one full one round of measurements. Data for 37 subjects was excluded as the data suggested existence of external conditions that interfere with RCT (reference clinical thermometer) or Rad-GT measurements. | Posted | Number | Degrees Celsius | 1-3 hours |
|
1-3 hours
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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 | Rad-GT | All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo RAD-GT Masimo RAD-GT: Non-contact infrared thermometry device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ahmed Alghazi | Masimo Corporation | 949-297-7000 | aalghazi@masimo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2023 | May 11, 2023 | Prot_SAP_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 68 |
| 0 |
| 68 |
| 0 |
| 68 |
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