Trial Outcomes & Findings for Form, Fit, and Function of INVSENSOR00061 (NCT NCT05926648)

Last Updated: 2024-09-25

Results Overview

The SpO2 accuracy of INVSENSOR00061 was determined by calculating the accuracy root mean squared (Arms) difference between the measured values (SpO2i) to the reference values (SpO2ref\_i) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SpO2ref\_i )\^2 ))/n

Recruitment status

COMPLETED

Study phase

Target enrollment

53 participants

Primary outcome timeframe

2 hours

Results posted on

2024-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Test Subjects All subjects who are enrolled into the test group and receive the noninvasive INVENSOR00061 INVSENSOR00061: Noninvasive pulse oximetry and pulse rate device
Overall Study STARTED	53
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Form, Fit, and Function of INVSENSOR00061

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Test Subjects n=52 Participants All subjects who are enrolled into the test group and received the noninvasive INVENSOR00061. INVSENSOR00061: Noninvasive pulse oximetry and pulse rate device
Age, Categorical <=18 years	52 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	24 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	21 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants
Region of Enrollment United States	52 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: 11 subjects not included in analysis due to incorrect sensor placement. 29 subjects not included in analysis due to absence of reference sensor used to calculate Arms.

Outcome measures

Outcome measures
Measure	Test Subjects n=12 Participants All subjects who are enrolled into the test group and received the noninvasive INVENSOR00061 and the reference sensor. INVSENSOR00061: Noninvasive pulse oximetry and pulse rate device
INVSENSOR00061 SpO2 Accuracy	1.02 % of SpO2

Adverse Events

Test Subjects

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 Corporation

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place