N/A
N=60
Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts
Fever
Bottom Line
View on ClinicalTrials.gov: NCT05787782 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Accuracy of Temperature Measurements Using Masimo INVSENSOR00063 — -0.24; 0.85; 0.05 Degrees Celsius
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Masimo INVSENSOR00063 (Device)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Temperature Measurements Using Masimo INVSENSOR00063 |
-0.24; 0.85; 0.05 | — |
Summary
This is a prospective, non-randomized data collection study to evaluate the performance of the Masimo INVSENSOR00063 in obtaining temperature measurements.
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
Data sourced from ClinicalTrials.gov (NCT05787782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.