Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements

Masimo

Status: Completed

Conditions: Healthy

Treatments: Device: Masimo INVSENSOR00057

Study type: Interventional

Funder types: Industry

Identifiers

NCT05462886

CIP-1020

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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86 participants in 1 patient group

Masimo INVSENSOR00057

Experimental group

Description:

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

Treatment:

Device: Masimo INVSENSOR00057