NCT05787782

Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

Completed NA Results posted Last updated 31 October 2025

What this trial tests

NA trial testing Masimo INVSENSOR00063 in Fever in 60 participants. Completed in 2 March 2023.

Timeline

23 February 2023

Primary endpoint
2 March 2023

2 March 2023

Quick facts

Lead sponsor	Masimo Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	60
Start date	23 February 2023
Primary completion	2 March 2023
Estimated completion	2 March 2023
Sites	1 location across United States

Drugs / interventions tested

• Masimo INVSENSOR00063

Conditions studied

• Fever — all drugs for Fever →

Sponsor

Masimo Corporation — full company profile →

Who can join

1 and older, any sex, with Fever. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Accuracy of Temperature Measurements Using Masimo INVSENSOR00063 Primary · 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.

Clinical Bias

Group	Value	95% CI
Masimo INVSENSOR00063	-0.24

Limits of Agreement

Group	Value	95% CI
Masimo INVSENSOR00063	0.85

Repeatability

Group	Value	95% CI
Masimo INVSENSOR00063	0.05

Sponsor's own description

This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining temperature measurements.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.