Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

Not Applicable

Completed

• Conditions: Fever
• Interventions: Device: Masimo INVSENSOR00063

• Registration Number: NCT05787782
• Lead Sponsor: Masimo Corporation

Brief 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).

Study Timeline

• Study Start: 2023-02-23
• Primary Completion: 2023-03-02
• Study Completion: 2023-03-02
• Study First Submitted: 2023-03-15
• Study First Submitted QC: 2023-03-15
• Study First Posted: 2023-03-28
• Results First Submitted: 2023-05-11
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-16
• Last Update Submitted: 2023-06-16
• Results First Posted: 2023-07-10
• Last Update Posted: 2023-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Participant age ≥ 1 year
• Afebrile or febrile at time of enrollment: For febrile subjects, ≥ 99.5 F/ 37.5 C for sublingual temperature reference; ≥ 100.4 F/ 38 C for temporal artery temperature reference.
• English-or Spanish-speaking patient or parent/Legal Guardian

Exclusion Criteria

• Participants deemed not suitable for the study at the discretion of the investigator

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Masimo INVSENSOR00063	Masimo INVSENSOR00063	All subjects are enrolled into this arm and will have temperature measurements obtained.

Primary Outcome Measures

Name	Time	Method
Accuracy of Temperature Measurements Using Masimo INVSENSOR00063	About 15-30 minutes	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.

Trial Locations

Locations (1)

Ascada Research; 🇺🇸 Fullerton, California, United States