Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-08

Study Completion Date

2022-07-21

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Masimo INVSENSOR00057

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00057 device.

Group Type EXPERIMENTAL

Masimo INVSENSOR00057

Intervention Type DEVICE

Noninvasive wearable health monitoring device

Interventions

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Masimo INVSENSOR00057

Noninvasive wearable health monitoring device

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes