Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements
September 3, 2024 updated by: Masimo Corporation
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Irvine, California, United States, 92618
- Masimo Corporation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Masimo INVSENSOR00057
All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00057 device.
|
Noninvasive wearable health monitoring device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Accuracy of Masimo INVSENSOR00057
Time Frame: 1-3 hours
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 8, 2022
Primary Completion (Actual)
July 21, 2022
Study Completion (Actual)
July 21, 2022
Study Registration Dates
First Submitted
July 14, 2022
First Submitted That Met QC Criteria
July 14, 2022
First Posted (Actual)
July 18, 2022
Study Record Updates
Last Update Posted (Actual)
September 24, 2024
Last Update Submitted That Met QC Criteria
September 3, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- CIP-1020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.