N/A
N=86
Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05462886 ↗Enrolled (actual)
86
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Heart Rate Accuracy of Masimo INVSENSOR00057 — 1.38 bpm
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Masimo INVSENSOR00057 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Heart Rate Accuracy of Masimo INVSENSOR00057 |
1.38 | — |
Summary
This study is designed to compare the accuracy of a noninvasive measurement of heart rate compared to reference values obtained by a standard of care ECG monitor.
Eligibility Criteria
Inclusion Criteria
- Subject is 18 to 80 years of age.
- Subject is able to read and communicate in English.
Exclusion Criteria
- Subject has open wounds, inflamed tattoos or piercings on the area of device placement, and/or has any visible healing wounds that the investigator and/or medical professional determines may place them at an increased risk for participation.
- Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
Data sourced from ClinicalTrials.gov (NCT05462886). 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.