Clinical Performance of Masimo Rad-GT
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Masimo Corporation
- Enrollment
- 68
- Locations
- 2
- Primary Endpoint
- Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius)
Study Overview
Brief Summary
The study is designed to validate the clinical performance of Masimo Rad-GT in the accuracy of temperature measurements.
Detailed Description
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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subject is 18 to 80 years of age.
- •Subjects are able to read and communicate in English as well as understand the study and the risks involved.
Exclusion Criteria
- •Subject is pregnant or nursing.
- •Subject has a known neurological and/or psychiatric disorder (e.g., schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subject's level of consciousness. *
- •Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
- •(* = Per study staff discretion)
Outcomes
Primary Outcomes
Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius)
Time Frame: 1-3 hours
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).
Secondary Outcomes
No secondary outcomes reported