NCT05779397

Clinical Performance of Masimo Rad-GT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: Masimo Corporation · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	Masimo RAD-GT	Non-contact infrared thermometry device

Timeline

• Start date: 2023-02-20
• Primary completion: 2023-02-23
• Completion: 2023-02-23
• First posted: 2023-03-22
• Last updated: 2023-07-25
• Results posted: 2023-07-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study