INVSENSOR00011 Clinical Performance Study

• Sponsor: Masimo Corporation (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03641937
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Days): 1
• Patients Per Site Per Month: 304.4

Study Details

Study Description

Brief Summary

This study assesses the investigational sensor's (INVSENSOR00011) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Device: INVSENSOR00011

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: INVSENSOR00011 Clinical Performance Study
• Actual Study Start Date: Jul 23, 2018
• Actual Primary Completion Date: Jul 24, 2018
• Actual Study Completion Date: Jul 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INVSENSOR00011 Test group The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor.	Device: INVSENSOR00011; INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.

Outcome Measures

Primary Outcome Measures

1. Sensitivity of INVSENSOR00011's Posture Change Detection [Approximately 30 minutes]

   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)

Secondary Outcome Measures

1. Respiratory Rate Detection [Approximately 20 minutes]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• 18 to 80 years old

• Physical status of ASA I or II

• Must be able to read and communicate in English

• Has signed all necessary related documents, e.g. written informed consent, health assessment questionnaire, gender and ethnicity form, confidentiality agreement

• Passed health assessment screening

Exclusion Criteria:

• Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study

• Inability to tolerate sitting still or minimal movement for at least 30 minutes

• Nursing female volunteers

• Excluded at the Principal Investigator's discretion

• Refusal to take pregnancy test (for female subjects)

• Positive pregnancy tests for female subjects of child bearing potential.

• Refusal to shave hair off areas where sensors will be applied (male subjects)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masimo Clinical Lab	Irvine	California	United States	92618

Sponsors and Collaborators

• Masimo Corporation

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 5, 2017

More Information

Publications

None provided.

• Responsible Party: Masimo Corporation
• ClinicalTrials.gov Identifier: NCT03641937
• Other Study ID Numbers: TP-19045A
• First Posted: Aug 22, 2018
• Last Update Posted: Jan 3, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Arm/Group Title	INVSENSOR00011 Test Group
Arm/Group Description	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.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	INVSENSOR00011 Test Group
Arm/Group Description	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.
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	9 90%
>=65 years	1 10%
Sex: Female, Male (Count of Participants)
Female	3 30%
Male	7 70%
Race/Ethnicity, Customized (Count of Participants)
White or Caucasian	4 40%
Black or African American	4 40%
Hispanic	1 10%
Native American	1 10%
Region of Enrollment (Count of Participants)
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Sensitivity of INVSENSOR00011's Posture Change Detection
Description	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)
Time Frame	Approximately 30 minutes

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	INVSENSOR00011 Test Group
Arm/Group Description	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.
Measure Participants	10
Measure Posture and Activity Related Transitions	100
Number [percent aggregate detection sensitivity]	99

2. Secondary Outcome

Title	Respiratory Rate Detection
Description	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.
Time Frame	Approximately 20 minutes

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	INVSENSOR00011 Test Group
Arm/Group Description	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.
Measure Participants	10
Mean (Standard Deviation) [breaths per minute]	3.64 (2.94)

Adverse Events

Time Frame	From the time of INVSENSOR00011 application until the sensor(s) is removed, approximately 30 minutes.
Arm/Group Title	INVSENSOR00011 Test Group
Arm/Group Description	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.
All Cause Mortality
	INVSENSOR00011 Test Group
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	INVSENSOR00011 Test Group
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	INVSENSOR00011 Test Group
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.