NCT05787782

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 23, 2023

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
3 months until next milestone

Results Posted

Study results publicly available

July 10, 2023

Completed
Last Updated

October 31, 2025

Status Verified

June 1, 2023

Enrollment Period

7 days

First QC Date

March 15, 2023

Results QC Date

May 11, 2023

Last Update Submit

October 29, 2025

Conditions

Fever

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Temperature Measurements Using Masimo INVSENSOR00063

    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.

    About 15-30 minutes

Study Arms (1)

Masimo INVSENSOR00063

EXPERIMENTAL

All subjects are enrolled into this arm and will have temperature measurements obtained.

Device: Masimo INVSENSOR00063

Interventions

Masimo INVSENSOR00063DEVICE

Masimo INVSENSOR00063 will be used to measure temperature

Masimo INVSENSOR00063

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ascada Research

Fullerton, California, 92835, United States

Location

Related Links

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Chelsea Frank
Organization
Masimo
clinicalresearchdept@masimo.com
949-297-7000

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2023

First Posted

March 28, 2023

Study Start

February 23, 2023

Primary Completion

March 2, 2023

Study Completion

March 2, 2023

Last Updated

October 31, 2025

Results First Posted

July 10, 2023

Record last verified: 2023-06

Locations

US(1)