Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements

NCT05462886 | Completed Results FDA Device

• 1 other identifier: CIP-1020
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

  1-3 hours

Study Arms (1)

Masimo INVSENSOR00057

EXPERIMENTAL

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

Device: Masimo INVSENSOR00057

Interventions

Masimo INVSENSOR00057 DEVICE

Noninvasive wearable health monitoring device

Masimo INVSENSOR00057

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 to 80 years of age.
• Subject is able to read and communicate in English.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Results Point of Contact

• Title: Ahmed Alghazi
• Organization: Masimo

studies@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: July 8, 2022
• Primary Completion: July 21, 2022
• Study Completion: July 21, 2022
• Last Updated: September 24, 2024
• Results First Posted: May 29, 2024

Record last verified: 2024-09

Locations

US (1)