Trial Outcomes & Findings for Desaturation Validation of INVSENSOR00038 (NCT NCT04017611)

Last Updated: 2020-10-20

Results Overview

This study will evaluate the trending accuracy of the INVSENSOR00038 relative to the reference value obtained from the comparative FDA-cleared device.

Recruitment status

COMPLETED

Study phase

Target enrollment

13 participants

Primary outcome timeframe

1-5 hours

Results posted on

2020-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	INVSENSOR00038 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00038 sensor. INVSENSOR00038: Noninvasive regional oximeter
Overall Study STARTED	13
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	INVSENSOR00038 All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00038 sensor. INVSENSOR00038: Noninvasive regional oximeter
Overall Study Withdrawn prior to completion	1

Baseline Characteristics

Desaturation Validation of INVSENSOR00038

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INVSENSOR00038 n=12 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00038 sensor. INVSENSOR00038: Noninvasive regional oximeter
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race/Ethnicity, Customized African American	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian or Pacific Islander	2 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	4 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-5 hours

This study will evaluate the trending accuracy of the INVSENSOR00038 relative to the reference value obtained from the comparative FDA-cleared device.

Outcome measures

Outcome measures
Measure	INVSENSOR00038 n=11 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive INVSENSOR00038 sensor. INVSENSOR00038: Noninvasive regional oximeter
Trending Accuracy of INVSENSOR00038	2.5 percentage of regional oxygen saturation

Adverse Events

INVSENSOR00038

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

Chelsea Frank

Masimo

Phone: (949) 297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place