Trial Outcomes & Findings for Clinical Equivalence of Masimo INVSENSOR00061 to RD SET Neo (NCT NCT05674136)

Last Updated: 2024-06-13

Results Overview

SpO2 accuracy was determined by calculating the root mean-squared (rms) 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

62 participants

Primary outcome timeframe

1-3 hours

Results posted on

2024-06-13

Participant Flow

Participant milestones

Participant milestones
Measure	Masimo INVSENSOR00061 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00061 sensor Masimo INVSENSOR00061: Noninvasive pulse oximeter sensor
Overall Study STARTED	62
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Equivalence of Masimo INVSENSOR00061 to RD SET Neo

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Masimo INVSENSOR00061 n=30 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00061 sensor Masimo INVSENSOR00061: Noninvasive pulse oximeter sensor
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 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	7 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-3 hours

Outcome measures

Outcome measures
Measure	Test Subject n=30 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00061 sensor INVSENSOR00061: Noninvasive pulse oximeter sensor
SpO2 Accuracy	1.24 % of oxygen saturated hemoglobin

Adverse Events

Masimo INVSENSOR00061

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Masimo INVSENSOR00061 n=62 participants at risk All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo INVSENSOR00061 sensor Masimo INVSENSOR00061: Noninvasive pulse oximeter sensor
Injury, poisoning and procedural complications Venipuncture or Intravenous puncture	6.5% 4/62 • 1-3 hours
Injury, poisoning and procedural complications Lightheadedness	3.2% 2/62 • 1-3 hours

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