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This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining 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 (NCT05787782, NCT05674344 and NCT05779397).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Masimo INVSENSOR00063 | Experimental | All subjects are enrolled into this arm and will have temperature measurements obtained. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Masimo INVSENSOR00063 | Device | Masimo INVSENSOR00063 will be used to measure temperature |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Temperature Measurements Using Masimo INVSENSOR00063 | Masimo INVSENSOR00063 temperature measurements will be compared to reference temperature measurements. Accuracy of Masimo INVSENSOR00063 will be measured using clinical bias, limits of agreement and repeatability. | About 15-30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascada Research | Fullerton | California | 92835 | United States |
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| Label | URL |
|---|---|
| Calibration and Validation of the Masimo Rad-G with Temperature device in Febrile Patients | View source |
| Clinical Performance of Masimo Rad-GT | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Masimo INVSENSOR00063 | All subjects are enrolled into this arm and will have temperature measurements obtained. Masimo INVSENSOR00063: Masimo INVSENSOR00063 will be used to measure temperature |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Masimo INVSENSOR00063 | All subjects are enrolled into this arm and will have temperature measurements obtained. Masimo INVSENSOR00063: Masimo INVSENSOR00063 will be used to measure temperature |
| 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 Temperature Measurements Using Masimo INVSENSOR00063 | Masimo INVSENSOR00063 temperature measurements will be compared to reference temperature measurements. Accuracy of Masimo INVSENSOR00063 will be measured using clinical bias, limits of agreement and repeatability. | Data for 1 subject was excluded as they did not complete one round of measurements. Data for 1 subject was excluded as the data suggested existence of external conditions that interefere with RCT (reference clinical thermometer) or Masimo INVSENSOR00063 measurements. | Posted | Number | Degrees Celsius | About 15-30 minutes |
|
15-30 minutes during data collection
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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 | Masimo INVSENSOR00063 | All subjects are enrolled into this arm and will have temperature measurements obtained. Masimo INVSENSOR00063: Masimo INVSENSOR00063 will be used to measure temperature |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chelsea Frank | Masimo | 949-297-7000 | clinicalresearchdept@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 17, 2023 | May 11, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D005334 | Fever |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
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