An interventional study of Masimo INVSENSOR00057 in Healthy, sponsored by Masimo Corporation. Completed at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by Masimo Corporation · Not applicable, Interventional, and Other
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.
Masimo Corporation is the lead sponsor of 103 studies on the registry; 1 is open to participants now.
Of its 78 completed or terminated interventional studies of FDA-regulated products, 65 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00057 device.
Device: Masimo INVSENSOR00057
Noninvasive wearable health monitoring device
Heart Rate Accuracy of Masimo INVSENSOR00057
Heart rate accuracy was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values from Masimo INVSENSOR00057 (TestHR_i) to the reference ECG monitor values (RefHR_i). Arms= √(∑(i=1 to n) ((TestHR_i-RefHR_i )\^2 ))/n
Time frame: 1-3 hours
| Milestone | Masimo INVSENSOR00057 |
|---|---|
| Started | 86 |
| Completed | 79 |
| Not completed | 7 |
Heart rate accuracy was determined by calculating the accuracy root mean-squared (Arms) difference between the measured values from Masimo INVSENSOR00057 (TestHR_i) to the reference ECG monitor values (RefHR_i). Arms= √(∑(i=1 to n) ((TestHR_i-RefHR_i )\^2 ))/n
| bpm | INVSENSOR00057 |
|---|---|
| Heart Rate Accuracy of Masimo INVSENSOR00057 | 1.38 |
Collected over 1-3 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Masimo INVSENSOR00057 | 0/86 (0%) | 0/86 (0%) | 0/86 (0%) |
| Age, Categorical(Participants) | Masimo INVSENSOR00057 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 79 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Masimo INVSENSOR00057 |
|---|---|
| Female | 36 |
| Male | 43 |
| Race (NIH/OMB)(Participants) | Masimo INVSENSOR00057 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 21 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 21 |
| More than one race | 8 |
| Unknown or Not Reported | 24 |
| Region of Enrollment(participants) | Masimo INVSENSOR00057 |
|---|---|
| United States | 79 |
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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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