NCT05787782

Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Masimo Corporation · Industry
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

Summary

This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining 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 (NCT05787782, NCT05674344 and NCT05779397).

Conditions

• Fever

Interventions

Type	Name	Description
DEVICE	Masimo INVSENSOR00063	Masimo INVSENSOR00063 will be used to measure temperature

Timeline

• Start date: 2023-02-23
• Primary completion: 2023-03-02
• Completion: 2023-03-02
• First posted: 2023-03-28
• Last updated: 2025-10-31
• Results posted: 2023-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study