Back to resultsValidation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts
Primary Purpose
Fever
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Masimo INVSENSOR00063
Sponsored by
About this trial
This is an interventional other trial for Fever
Eligibility Criteria
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
Sites / Locations
- Ascada Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Masimo INVSENSOR00063
Arm Description
All subjects are enrolled into this arm and will have temperature measurements obtained.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05787782
Brief Title
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts
Official Title
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 23, 2023 (Actual)
Primary Completion Date
March 2, 2023 (Actual)
Study Completion Date
March 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masimo Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Masimo INVSENSOR00063
Arm Type
Experimental
Arm Description
All subjects are enrolled into this arm and will have temperature measurements obtained.
Intervention Type
Device
Intervention Name(s)
Masimo INVSENSOR00063
Intervention Description
Masimo INVSENSOR00063 will be used to measure temperature
Primary Outcome Measure Information:
Title
Accuracy of Temperature Measurements Using Masimo INVSENSOR00063
Description
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.
Time Frame
About 15-30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Ascada Research
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
12. IPD Sharing Statement
Links:
URL
https://clinicaltrials.gov/ct2/show/NCT05674344?term=choc0008&draw=2&rank=1
Description
Calibration and Validation of the Masimo Rad-G with Temperature device in Febrile Patients
URL
https://clinicaltrials.gov/ct2/show/NCT05779397?term=CIP-1064&draw=2&rank=1
Description
Clinical Performance of Masimo Rad-GT
Learn more about this trial
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts
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