Trial Outcomes & Findings for Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements (NCT NCT05462886)

Last Updated: 2024-09-24

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

86 participants

Primary outcome timeframe

1-3 hours

Results posted on

2024-09-24

Participant Flow

Participant milestones

Participant milestones
Measure	Masimo INVSENSOR00057 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00057 device. Masimo INVSENSOR00057: noninvasive wearable health monitoring device
Overall Study STARTED	86
Overall Study COMPLETED	79
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance of Masimo INVSENSOR00057 for Heart Rate Measurements

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Masimo INVSENSOR00057 n=79 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00057 device. Masimo INVSENSOR00057: noninvasive wearable health monitoring device
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	79 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	36 Participants n=93 Participants
Sex: Female, Male Male	43 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	21 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	5 Participants n=93 Participants
Race (NIH/OMB) White	21 Participants n=93 Participants
Race (NIH/OMB) More than one race	8 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	24 Participants n=93 Participants
Region of Enrollment United States	79 participants n=93 Participants

PRIMARY outcome

Timeframe: 1-3 hours

Population: 17 subjects not included in analysis due to data collection error.

Outcome measures

Outcome measures
Measure	INVSENSOR00057 n=62 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00057 device. INVSENSOR00057: noninvasive wearable health monitoring device
Heart Rate Accuracy of Masimo INVSENSOR00057	1.38 bpm

Adverse Events

Masimo INVSENSOR00057

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ahmed Alghazi

Masimo

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place