INVSENSOR00027 Fall Detection Clinical Performance Study
Phase: NA
Conditions: Healthy
Sponsor: Masimo Corporation

 
 
Official Title: INVSENSOR00027 Fall Detection 
Clinical Performance Study 
 
Date of Protocol: Dec. 3, 2019 
 
NCT Number:   NCT04224753 

PROTOCOL/TEST PROCEDURE 
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CO-056992 
 
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Protocol/Test Procedure Title 
INVSENSOR00027 Fall Detection Clinical Performance Study  
Lead Investigator 
Ahmed Alghazi, MD 
Sr. Manager, Clinical Lab  
Masimo Corporation 
52 Discovery, Irvine, CA 92618 
Other Investigators 
N/A 
Expected Start Date 
N/A 
Expected End Date 
N/A 
IRB 
E&I West Coast Board – IRB00007807 
 
Protocol Test Abstract: 
This study assesses the investigational sensor’s (INVSENSOR00027) fall detection performance. 
 
 
APPROVALS 
Author 
Date 
Engineering 
Date 
Ahmed Alghazi, 
Amany Khalil  
 
 
 
Quality Assurance 
Date 
Manufacturing 
Date 
 
 
 
 
 

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STATEMENT OF COMPLIANCE  
 
This document is a protocol for a clinical research study sponsored by Masimo Corporation.  The study will be 
conducted in compliance with all stipulations of this protocol, the conditions of IRB approval, 21 CFR Part 50, 21 
CFR Part 56, 21 CFR Part 812, ISO-14155, and International Conference on Harmonisation E6 Good Clinical 
Practice (ICH GCP). 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the 
Institutional Review Board (IRB) for review and approval.  Approval of both the protocol and the consent form must 
be obtained before any participant is enrolled.  Any amendment to the protocol will require review and approval by 
the IRB before the changes are implemented to the study.   
1. 
PURPOSE  
 
The objective of this study is to assess INVSENSOR00027’s fall detection clinical performance in healthy 
volunteers. 
 
This is a nonrandomized single arm study where all of the subjects are enrolled into the experimental arm and 
will receive the INVSENSOR00027 device on their chest.  
 
Outcome Measure: Assess the fall detection clinical performance. 
 
2. 
BACKGROUND  
 
Masimo Corporation develops non-invasive medical technologies. These devices have applications in the 
operating room, critical care unit, emergency room, emergency transport vehicles, as well as physician’s 
offices.  
2.1. 
Background and Rationale     
Masimo has developed a new noninvasive sensor named INVSENSOR00027 as a device to aid in 
preventing hospital-acquired pressure injury or worsening of existing pressure injury by monitoring 
patient movement, position, and orientation. The sensor is also able to detect falls through the same 
monitoring features. This type of monitoring may be effective in reducing the debilitating conditions 
for patients and their duration of stay in hospitals, especially in the patient population vulnerable to 
fall related injuries.  
As many as 1 million Americans fall in the hospital every year. Falls result in fractures, lacerations, 
bleeding and even death. Current practices to prevent falls include assessment of patient risk, 
scheduled rounding practices and patient specific interventions to prevent falls [1]. The 
INVSENSOR00027 device is proposed to supplement current practices with a unique modality to 
assess risk for fall based on patient position. 
The INVSENSOR00027 system consists of a wearable, battery-operated, adhesive sensor and a 
back-end user interface and display at the patient bedside as well as a central location (e.g., nursing 
station). The sensor contains sensing elements (accelerometers, gyroscopes), processor, and a blue-
tooth communication chip (BTLE 2.4 GHz). An algorithm processes three-dimensional acceleration 
and rotation information and calculates the patient’s relative position and fall, heart rate and 
respiration rate as its key parameters. Position related parameters are then combined over a given 
time period to compute trend and potential risk for pressure injury. The system can generate alarms 
configured for adverse events related to patient posture, stress level for pressure injury and detected 
fall events. 

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Literature Review: 
 
1. Ganz, DA, Huang, C, Saliba D, et al. Preventing falls in hospitals: A toolkit for improving quality 
of care. (Prepared by RAND corporation, Boston University School of Public Health, and ECRI 
Institute under Contract No. HHSA2902010000171 TO#1). Rockville, MD: Agency for 
Healthcare Research and Quality; January 2013. AHRQ Publication No. 13-0015-EF. 
 
2.2. 
Study Devices  
2.2.1. Investigational Devices and Sensors:   
2.2.1.1. INVSENSOR00027 sensor is an investigational, non-invasive sensor that 
measures signals regarding patient’s movement and posture, pulse rate, and 
respiratory rate. This sensor has undergone a risk assessment prior to use in 
human subjects to safeguard their safety and well-being. Refer to IB-00142A.  
2.2.1.2. Root® is a noninvasive monitoring platform. The version of the device used in 
this study, as compared to the FDA cleared device, contains a software 
modification to allow for Bluetooth connection to the INVSENSOR00027 sensor 
and the display of INVSENSOR00027 parameters.  The software update has 
undergone a risk assessment prior to use in human subjects to safeguard their 
safety and well-being. Refer to IB-00129B.  
3. 
REFERENCE 
3.1.1. FRM-4900 Rev. A 
Consent To Be A Research Subject 
3.1.2. FRM-4901 Rev. A 
Recruitment Script 
3.1.3. FRM-4902 Rev. A 
Web Ad 
3.1.4. FRM-4903 Rev. A 
Health Questionnaire  
3.1.5. FRM-3124 Rev. A 
Confidentiality Agreement 
3.1.6. FRM-4904 Rev. A 
Case Report Form 
3.1.7. FRM-1084 
 
Volunteer Payment Form 
3.1.8. FRM-3336  
 
Device Accountability Log 
3.1.9. FRM-2706 
 
Protocol Deviation Report 
3.1.10. FRM-3280 
 
Adverse Event Form 
3.1.11. FRM-2336 
 
Clinical Study Request Form 
4. 
LOCATION 
Masimo Corporation 
Clinical Laboratory  
 
52 Discovery 
 
Irvine, CA 92618 
 
The Masimo Clinical Laboratory facility is designed as a Phase 1 clinical study research center. All personnel 
undergo routine required training on GCP and human subject research protections. The laboratory is equipped 

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with standard FDA-approved medical monitoring equipment. Hospitals and urgent care facilities are within 
three miles of Masimo Clinical Laboratory.  
 
 
 
5. 
EQUIPMENT, MATERIALS AND SAMPLE SIZE JUSTIFICATION   
5.1. 
Equipment and Materials 
Equipment and Materials: All lab equipment will be maintained per manufacturer specifications and 
all study personnel will be trained on the use of relevant equipment. 
Test Devices:  
x 
INVSENSOR00027 
x 
Root with modified software to allow for communication with INVSENSOR00027 
x 
Data Collection Laptop, software and other equipment as necessary to record the data 
5.2. 
Sample Size Justification 
5.2.1. 
STUDY POPULATION   
Inclusion Criteria 
x 
18 to 45 years old  
x 
Physical status of ASA I or II 
x 
Subjects must be able to read and communicate in English 
x 
Has signed all necessary related documents, e.g. written informed consent, volunteer payment 
form, confidentiality agreement  
x 
Has completed Health Assessment Questionnaire and passed health assessment screening 
Exclusion Criteria  
x 
Subject has any medical condition which in the judgment of the investigator, renders them 
inappropriate for participation in this study 
x 
Inability to tolerate physical activities including jumping and fall simulation 
x 
Nursing female volunteers 
x 
Excluded at the Principal Investigator’s discretion 
x 
Refusal to take the pregnancy test (for female subjects) 
x 
Positive pregnancy test for female subjects of child bearing potential. This is done for the 
safety of this population.  
x 
Refusal to shave hair (chest) off areas where sensors will be applied (male subjects) 
Withdrawal of Subjects 
Subjects must be withdrawn under the following circumstances: 
x 
The subject withdraws consent  
x 
Non-verbal consent withdrawal 
x 
Serious adverse event 
x 
Discretion of investigator 
x 
Malfunction of the device for greater than 10 minutes 
 
 

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We apply the following model to determine minimum data points needed for sensitivity calculation.  
ܰൌ
൫௓భషഀȀమ൯
మכௌכሺଵିௌሻ
௅మכ௉
, 
where Z is the standard score from normal distribution; its value is set to 1.96, reflecting a 
95% confidence interval. P is the likelihood of the event occurring; given that all subjects are 
mandated to follow the same protocol, this value is always 100%. S is the anticipated 
sensitivity of detection, with its desired precision denoted by L.  
For our analysis, S is set to be 90% and L is set to 10%. (We expect a higher success rate, which will 
only lead to smaller sample size requirement.) (We expect a higher success rate, which will only lead 
to smaller sample size requirement.) With these assumptions, N is computed to be 35. 
 
6. 
PROCEDURES 
6.1. 
Advertisement and Recruitment  
6.1.1. Our Web Ad (FRM-4902A) will be posted publically on craigslist or similar 
websites.  
6.2. 
Phone Screening 
6.2.1. Once the potential subject sees the recruitment material (i.e. Web Ad), they contact 
our clinical schedulers to elicit more details about the screening. The phone 
screening is handled by designated clinical staff that is trained for 
screening/scheduling. 
6.2.2. Appointments are made once the phone screening process is completed and the 
person screening the subject determines they qualify for screening based on the 
Recruitment Script (FRM-4901A).  
6.2.3. If the person does not qualify at this time their information will not be kept.  
6.3. 
Consent Process.  
6.3.1. Have each volunteer read and sign the correct forms which include the Consent 
form (FRM-4900A), Confidentiality Agreement (FRM-3124A), and Volunteer 
Payment Form (FRM-1084). The consent form must be stamped with current IRB 
approval. No study related activities will be conducted until consent is signed.  
6.4. 
Screening: 
6.4.1. Have each subject complete FRM-4903A – Health Assessment Questionnaire. 
Subject demographic information including age, gender, height, weight, Massey 
scale, and ethnicity may be collected.    
6.4.2. Female volunteers of child bearing potential will be required to take a pregnancy 
test as part of screening. A positive pregnancy test will disqualify them from the 
study.  
6.4.3. If the subject does not pass screening, he/she will be compensated $25 for travel. 
 
 

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6.5. 
 Study procedure  
6.5.1. Apply sensors. INVSENSOR00027 sensors will be placed on the subject’s chest. In 
some cases it may be required for subjects to shave their chest for the purpose of 
applying the adhesive sensors with their consent. The study starts once the sensor is 
placed.   
6.5.2. Photos may be taken of sensor placement. Photos may only be taken with the 
subject’s consent. All photos will be de-identified and will not show the subject’s 
face or any other identifying features.   
6.5.3. Subjects will be asked to perform a series of falls onto a thick cushioned mattress. 
Clinical study staff will document the length of data collection on the Case Report 
Form (FRM-4904A).  
6.5.4. In the event the subject fails screening, he/she will be compensated $25 for travel. 
6.5.5. If the subject passes screening and participates in the study, they will not receive 
travel compensation and will be paid $75 for completing the study. Subjects may 
stop the study at any time. If the subject withdraws from the study any time after the 
placement of the sensors, he/she will be paid $25.  
6.5.6. Data collected in this study may be used in the future for product development, 
publications, and/or submissions to the FDA or other regulatory agencies. 
6.6. 
Discontinuation  
6.6.1. In the event that a study is discontinued prior to completion, whether it is due to the 
investigator’s discretion or the subject’s request, the subject will be paid $25 
6.7. 
Protocol Deviation 
6.7.1. If there is a protocol deviation it shall be recorded on the Case Report Form. The 
Protocol Deviation Report (FRM-2706) shall also be completed.  
7. 
ACCEPTANCE CRITERIA (JUSTIFY IF NOT APPLICABLE) 
7.1. 
Aggregate fall detection events across all subjects has sensitivity that is greater than or equal to 
90%. 
8. 
DATA ANALYSIS PROCEDURE TO BE USED 
8.1. 
For each subject’s fall simulation, INVSENSOR00027 output will be computed 
8.2. 
Expected Dropout Rates: Subjects may not complete the study for various reasons, such as a clinical 
screening test failure, at the Principal Investigator’s discretion, or because the subject does not want 
to continue the study. Expected dropout rate for this study is approximately 0% of the total number 
of subjects enrolled.  
 
 
 

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9. 
 ADVERSE EVENTS 
               Definitions:  
Adverse event:  Any untoward medical occurrence in a subjects, users or other persons, whether or not 
related to the medical device under study. 
 
Device-related adverse event:  Adverse event related to, associated with, or caused by, the use of a medical 
device under study, including but not limited to events that may have been attributed to the device because 
of device failure or malfunction, improper or inadequate design, manufacture or user error. 
Device deficiency: Inadequacy of a medical device with respect to its identity, quality, durability, 
reliability, safety or performance.  Device deficiencies include malfunctions, use errors and inadequate 
labeling. 
If there is a device deficiency during the study, it will be documented on the Case Report Form, FRM-
4433A and it will be reported according to department procedures.  
Serious adverse event:  Adverse event that: a) led to death, b) led to serious deterioration in the health of the 
subject, that resulted in: (i) a life-threatening illness or injury,  (ii) a persistent or significant impairment of a 
body structure or a body function, (iii) in-patient or prolonged hospitalization, or (iv) medical or surgical 
intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a 
body function, or c) led to fetal distress, fetal death or a congenital abnormality or birth defect.  NOTE:  
Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigational 
plan, without serious deterioration in health, is not considered a serious adverse event. 
9.1. 
Adverse Events  
All devices used in the study are non-significant risk devices.  All study procedures are noninvasive.  In 
the unlikely event that an adverse event should occur, it will be reported and documented as described 
below. 
All adverse events that occur during the study shall be recorded on the Case Report Form. The Adverse 
Event Report Form (FRM-3280) shall also be completed.  
Skin irritation or redness from the adhesive are anticipated adverse events. 
9.2. 
Serious and Unanticipated Adverse Events    
The investigator shall promptly report to the IRB within 24 hours any serious and unanticipated adverse 
event involving subjects. 
At the time of discharge from the study, an unresolved serious and unanticipated adverse event(s) will be 
followed up by the investigator until the event(s) are resolved, stabilized, or the patient is unable to 
follow-up or the adverse event is otherwise explained.  The investigator will also instruct the subject to 
report any subsequent events occurring in the next 30 days, which the subject or the subject’s physician 
believes might reasonably be regarded as caused by or have a reasonable possibility of being caused by 
the test device or procedures involved in the study. 
9.3. 
Unanticipated Problems 
Any unanticipated problems involving subjects will be reported to the IRB, such as protocol violations or 
deviations as required by the IRB reporting procedures.  
 
 
 

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10. 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1. 
Measures Taken to Protect the Rights and Welfare of Subjects 
10.1.1. All subjects will be monitored closely throughout the study.   
10.1.2. The following measures will be taken to ensure the privacy of the subjects: 
10.1.2.1 Information about the patients will be kept confidential. 
10.1.2.2 An identification number (code) for each subject will be kept on file 
10.1.2.3 The study documents will only contain the subject’s corresponding 
Identification number except in the Informed Consent Document. 
10.1.2.4 Access to identifying documents and data will only be granted to the 
investigators in the study. 
10.1.2.5 Study data that will be released to Masimo and other regulatory authorities 
will be de-identified and will only pertain to study data collection, 
demographics, sensor placement locations and recordings from devices. 
10.1.2.6 The confidentiality and retention of these documents will be protected to the 
extent provided and required by the law 
10.2. 
Vulnerable Population 
10.2.1. Employees are considered to be a vulnerable population. 
 Participation is not a condition of employment. There will be no repercussions in 
the workplace in the case that the employee refuses to participate in the study or 
withdraws at any point during the study. Neither supervisors nor superiors will be 
involved in the recruitment of employees for participation in the study. 
10.2.2. Economically disadvantaged or unemployed and educationally disadvantaged. 
Reasonable compensation will be provided for economically disadvantaged 
subjects to eliminate the possibility of undue influence due to financial incentive. 
10.2.3. Educationally disadvantaged subjects will be provided ample time to ask questions 
and comprehend information.   
 
 

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10.4. 
Documents and Database  
10.4.1. Documents will be kept a minimum of 5 years after the specific product/tested for is 
no longer being made. If destroyed, these documents will be shredded and done by a 
certified company used for destroying medical and clinical data. 
10.4.2. Documents and information stored electronically will be protected using a multi-
faceted procedures included, but not limited to, the following steps: 
10.4.3. Endpoint: 2 layers of endpoint security and one layer of DLP (Data loss prevention) 
running on all company machines. 
10.4.4. Premier firewalls/Network monitoring appliances and log collection systems 
(SIEM) protecting the network 
10.4.5. 4 layers of email security systems for protecting against phishing attacks 
10.4.6. Security policies to limit access to specific folders 
 
 
10.5. 
Device Accountability  
10.5.1. Receipt of Study Device 
Upon receipt of the study device supplies, an inventory must be performed and the 
Device Accountability Log FRM-3336 filled out and signed by the person accepting 
the shipment. It is important that the designated study staff counts and verifies that 
the shipment contains all the items noted in the shipment inventory. Any damaged 
or unusable study devices in a given shipment will be documented in the study files.   
10.5.2. Use of Study Device  
Use of devices and sensors will be documented on Case Report Form for each 
subject. 

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11. 
RISKS AND BENEFITS  
11.1.1. Benefits 
There would be no other benefit to the subject. Other possible benefits would be to 
society as a whole. 
11.1.2. Device Risks 
Risks of skin irritation or redness to adhesives. Additionally any device may leave a 
temporary mark on the subject’s skin.  
11.1.3. Risks associated with disclosure of confidential information 
There is minimal risk to the privacy of the subject because access to study data will 
be kept in a secure location and limited to study personnel and to others legally 
authorized to view it.  
11.1.4. Risks associated with study procedures  
11.1.4.1. Risk of bruising due to repeated fall simulations, this will be mitigated by    
using a cushioned mattress and protective gear. 
11.1.4.2. Risk of dizziness due to repeated changes in posture. If this happens the study 
staff will terminate the study and take the appropriate actions to alleviate the 
symptom.     
11.1.5. EMERGENCY RESPONSE PLAN FOR MEDICAL EMERGENCIES 
 A crash cart is on site and emergency services are available within a 3 mile radius 
of the facility.  
11.1.6. MONITORING PLAN 
A separate document for the study monitoring plan will be developed and followed 
to ensure subject safety and GCP compliance. 
11.1.7. PROTOCOL DEVIATIONS AND AMENDMENTS 
Deviations from the protocol will be documented on the Case Report Form or a 
separate document.  Protocol deviations will be reported to the sponsor and IRB per 
IRB reporting guidelines. 
11.1.8. Modifications to the protocol, informed consent materials, recruitment materials, or 
any other materials provided to subjects must be reviewed and approved by the IRB