Trial Outcomes & Findings for INVSENSOR00011 Clinical Performance Study (NCT NCT03641937)

NCT ID: NCT03641937

Last Updated: 2022-01-03

Results Overview

Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00011's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)

Recruitment status

TERMINATED

Target enrollment

10 participants

Primary outcome timeframe

Approximately 30 minutes

Results posted on

2022-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	INVSENSOR00011 Test Group The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor. INVSENSOR00011: INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.
Overall Study NOT COMPLETED	0
Overall Study STARTED	10
Overall Study COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

INVSENSOR00011 Clinical Performance Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	INVSENSOR00011 Test Group n=10 Participants The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor. INVSENSOR00011: investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	4 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=5 Participants
Race/Ethnicity, Customized Native American	1 Participants n=5 Participants
Region of Enrollment United States	10 Participants n=5 Participants

PRIMARY outcome

Timeframe: Approximately 30 minutes

Population: The protocol required a minimum of 30 subjects to sufficiently evaluate a detection sensitivity for INVSENSOR00011 sensor's posture change detection algorithm. The study was not able to meet this enrollment target and enrolled only 10 subjects, therefore data should be interpreted with caution due to the insufficient sample size. Across 10 enrolled subjects, there were 100 posture and activity related transitions observed (these include right, left, supine, upright and walking events).

Outcome measures

Outcome measures
Measure	INVSENSOR00011 Test Group n=100 Posture and Activity Related Transitions The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor. INVSENSOR00011: INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.
Sensitivity of INVSENSOR00011's Posture Change Detection	99 percent aggregate detection sensitivity

SECONDARY outcome

Timeframe: Approximately 20 minutes

Population: The protocol required a minimum of 30 subjects to sufficiently evaluate accuracy of the RR parameter. The study was not able to meet this enrollment target, therefore data should be interpreted with caution due to the insufficient sample size. An error analysis was carried out with reference measurements to assess INVSENSOR00011's RR accuracy. Across 10 enrolled subjects, the RR values from the device was compared against the reference RR to compute mean and standard deviation of bias (SDE).

When INVSENSOR00011 respiratory rate (RR) readings are available, it will be compared against reference respiratory rate by computing mean and standard deviation of the differences.

Outcome measures

Outcome measures
Measure	INVSENSOR00011 Test Group n=10 Participants The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor. INVSENSOR00011: INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.
Respiratory Rate Detection	3.64 breaths per minute Standard Deviation 2.94

Adverse Events

INVSENSOR00011 Test Group

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