Surveillance and Alert-based Multiparameter Monitoring to Reduce Worsening Heart Failure Events - SCALE-HF1
Conditions: Heart Failure
Sponsor: Bodyport Inc.

  
 
 
 
 
 
 
SURVEILLANCE AND ALERT-BASED MULTIPARAMETER 
MONITORING TO REDUCE WORSENING HEART FAILURE EVENTS 
- SCALE-HF 1 
 
A prospective, multicenter study designed to evaluate how the 
Bodyport Cardiac Scale and biomarkers change with worsening 
heart failure 
 
Principal Investigator: Adam DeVore, MD, MHS 
Duke Clinical Research Institute 
Draft or Version Number:  2.0 
2 March 2021 
 
 
 
 

LIST OF TABLES AND FIGURES 
 
Table  1. 
List of Abbreviations………………….…………….……………..……….………………………………2 
Figure 1. 
SCALE-HF Overall Design………………………………………………….………………………………5 
 
Table  2. 
SCALE-HF 1 Schedule of Events….…………………………………………………….………………8 
ABBREVIATIONS 
Table 1. List of Abbreviations 
BCG 
Ballistocardiograph 
CFR 
Code of Federal Regulations 
DCRI 
Duke Clinical Research Institute 
ECG 
Electrocardiograph 
GCP 
Good Clinical Practice 
HF 
Heart Failure 
HFrEF 
Heart failure with reduced ejection fraction 
HFpEF 
Heart failure with preserved ejection fraction 
IPG 
Impedance plethysmograph 
LVEF 
Left Ventricular Ejection Fraction 
US 
United States 
 
STATEMENT OF COMPLIANCE 
The trial will be carried out in accordance with Good Clinical Practice (GCP) as required by the following: 
• United States Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part 46, 
21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812) 
• International Council on Harmonisation (ICH) E6 
 
I agree to ensure that all staff members involved in the conduct of this trial are informed about their 
obligations in meeting the above commitments. 
 
Principal Investigator: Adam DeVore, MD, MHS 
 
Signed: ______________________________________________  Date:  ___________________ 
 
 
 
 

PROTOCOL SUMMARY 
Title: 
SurveillanCe and Alert-based multiparameter monitoring to reducE 
worsening Heart Failure events – SCALE-HF 1 
Summary: 
The overarching goal of this prospective, multicenter study is to utilize 
data from the Bodyport Cardiac Scale to develop an algorithm that allows 
for the early detection of worsening heart failure (HF). The Bodyport 
Cardiac Scale is capable of measuring key HF parameters of congestion 
and cardiac perfusion on a regular basis in a patient’s home. These data 
will be combined into a model or composite index that may be used to 
identify patients at increased risk for decompensation, inform the reason 
for their decline, and offer the possibility to remotely optimize therapy to 
prevent further worsening HF.  
 
The SCALE-HF program will consist of multiple phases. For SCALE-HF 1, 
patients will be prospectively enrolled and utilize the Bodyport Cardiac 
Scale on a daily basis. Patients and clinicians will be blinded to the results 
other than data readily available from other devices such as body weight. 
There will be no attempt to influence clinical practice. Patients will be 
followed remotely for suspected clinical events.  
Objectives: 
 
The primary objective of this study is to utilize data from the Bodyport 
Cardiac Scale to develop a model that allows for the early detection of 
worsening HF.  
Endpoints: 
The primary endpoint of the study will be worsening HF. Worsening HF will 
be defined as an urgent, unscheduled clinic or emergency department visit 
or hospital admission with a primary diagnosis of HF in which the patient 
exhibited new or worsening symptoms of HF on presentation, had 
objective evidence of new or worsening HF, and received initiation or 
intensification of treatment for HF.  
Design 
This study is intended to enroll a broad population of patients. Patients 
may      be consented and enrolled remotely, in clinic, or prior to hospital 
discharge. Training on device use will be provided and daily utilization will 
be requested. Device sensor data will be uploaded remotely and analyzed 
on a continuous basis. Treating clinicians will be blinded to the 
investigational sensor data. 
 
Follow-up will occur remotely at 6 weeks, 3 months and then every 3 
months until the end of the study. Patients may also be contacted by the 
site and/or study team for suspected device malfunction or nonadherence 
with the Bodyport Cardiac Scale. 
 
At each interview, participants will be asked to report possible clinical 
events. Sites may also be queried to report possible clinical events. All 
patients will consent to release of medical records regarding HF history 
and suspected clinical events. Based on site- and participant-reported 
events, medical billing data and medical records for possible clinical events 
will be collected. Possible clinical events will be reviewed and adjudicated 

by a clinical events committee using standardized definitions. The 
committee members will be blinded to sensor and algorithm data. 
Population: 
Approximately 300 male and female participants in the US, 18 years of age 
or older, irrespective of left ventricular ejection fraction with symptomatic 
HF will be enrolled. Patients must be able to stand independently on the 
Bodyport Cardiac Scale. 
 
We will exclude patients with a weight > 170 kg, prior heart transplant or 
currently listed for heart transplant, current LVAD, current inotropes, and 
end-stage renal disease requiring chronic dialysis.  
Sites Enrolling 
Participants: 
Approximately 5 US sites 
Duration of Study 
Approximately 1 year (6 months enrollment and approximately 6 months 
follow up) 
Study Product 
Bodyport Cardiac Scale 
 
SCHEMATIC OF SCALE-HF STUDIES  
 
Figure 1. SCALE-HF Overall Design. Scale-HF 1 will be the first in a series of studies that aims to evaluate 
the use of the Bodyport Cardiac Scale to rapidly identify early worsening HF in order to allow for clinical 
interventions to prevent disease progression. 

1. KEY ROLES 
Principal Investigators: 
Adam DeVore, MD, MHS 
Duke Clinical Research Institute 
200 Morris Street, 6318 
Durham, NC 27701 
919-668-8246 
adam.devore@duke.edu 
 
Project Manager: 
Linda Davidson-Ray 
Duke Clinical Research Institute 
PO Box 17969 
Durham NC 27715 
919-668-8724 
david006@mc.duke.edu 
Marat Fudim, MD, MHS 
Duke Clinical Research Institute 
200 Morris Street, 6318 
Durham, NC 27701 
919-684-1284 
marat.fudim@duke.edu 
 
Academic Research Organization/Coordinating 
Center: 
Duke Clinical Research Institute 
Durham NC 
 
 
2. BACKGROUND AND TRIAL RATIONALE  
2.1 BACKGROUND INFORMATION  
 
Heart failure (HF) is a major health, social and economic problem worldwide.1 The incidence and 
prevalence of HF are increasing,2 in part due to an aging population and rising burden of comorbidities.3 
Efforts to decrease mortality, decrease hospitalization rates and improve the well-being of patients with 
HF were modestly successful over the last decade with the introduction of medical therapies and care 
strategies.4 However, despite advances in medical and device therapies, the number of hospitalizations 
for HF and associated readmissions remains high and represents an increasingly unsustainable financial 
burden.5 As a result, reducing HF readmission rates has become a priority in many of the developed 
countries. In the US alone, the costs related to HF are expected to reach $70 billion by 2030, an increase 
of 130% on current costs.6-8  
 
Achieving and maintaining an euvolemic status is a key goal in the management of HF. Thus, close 
observation of, and rapid response to changes in early physiological indicators are essential in achieving 
or maintaining euvolemia. Clinical signs and symptoms of HF decompensation are preceded by an 
increase in filling pressures, autonomic adaptation and resultant cardiac function and total fluid content 
changes.  
 
The Bodyport Cardiac Scale provides an innovative and noninvasive approach to obtain clinically 
relevant hemodynamic parameters. The Bodyport Cardiac Scale is a physical platform in which the user 
stands with bare feet. The scale captures a number of physiological parameters including weight, 
electrocardiogram, impedance plethysmography and ballistocardiography to derive a proprietary 

algorithm to monitor for cardiac decompensation through a preceding change in heart rate, cardiac 
output, stroke volume, cardiac time intervals, body weight and other biomarkers. Bodyport Cardiac 
Scale biomarkers are transmitted to a HIPAA-compliant cloud via an integrated cellular LTE-M modem 
for storage and visualization in a web-based application. The simplicity of the Bodyport Cardiac Scale 
enables patients to use the system at home, allowing patients to be monitored remotely and make 
treatment decisions with their medical team without the need for an in-person visit. 
2.2 RATIONALE 
Despite recent advancements in medical therapy, many patients with HF continue to have a high burden 
of symptoms and are at increased risk for adverse outcomes. As noted above, management of 
worsening HF also represents a major economic burden on the public health system. Worsening HF is 
characterized by the need for rehospitalization or urgent outpatient treatment for acute HF in order to 
control symptoms, preserve end organ function, and prevent further disease progression including 
death. There remains an urgent need to detect early worsening HF in order to allow for clinical 
interventions to prevent disease progression. 
2.3 POTENTIAL RISKS 
The known risks to participants in the trial will be minimal, as SCALE-HF 1 will be limited to data 
collection. Risk is involved to the extent that privacy and confidentiality may be compromised. However, 
every reasonable effort will be made to limit breaches of privacy and confidentiality. 
3. OBJECTIVES AND ENDPOINTS 
3.1 PRIMARY OBJECTIVES 
 
The primary objective of this study is to utilize data from the Bodyport Cardiac Scale to develop an 
algorithm that allows for the early detection of worsening HF.  
3.1 SECONDARY OBJECTIVES 
 
The secondary objectives of this study are to compare data from the Bodyport Cardiac Scale to: 
● Data obtained from approved implantable devices and sensors 
● Data obtained from other markers of congestion including invasive hemodynamics, biomarkers, 
and blood volume analysis 
3.2 ENDPOINTS 
 
The primary endpoint of the study will be worsening HF.  
 
Worsening HF will be defined as an urgent, unscheduled clinic (requiring IV diuretics) or emergency 
department visit or hospital admission with a primary diagnosis of HF in which the patient exhibited new 
or worsening symptoms of HF on presentation, had objective evidence of new or worsening HF, and 
received initiation or intensification of treatment for HF.  
 
Information will also be collected on death and any mortality events will be classified as cardiovascular 
or non-cardiovascular. We will also collect data on arrhythmic events requiring hospitalizations or a 
defibrillator shock where the collected data allows such an assessment.  

4. STUDY DESIGN 
4.1 OVERALL STUDY DESIGN 
 
SCALE-HF 1 is a prospective, multicenter study. The overarching goal is to enroll a broad population of 
patients with HF and follow them remotely for clinical events. Patients will be identified by participating 
sites and may be consented and enrolled remotely, in clinic, or prior to hospital discharge. Follow-up 
visits will be remote and occur at 6 weeks, 3 months and then every 3 months until the end of the study. 
Follow-up information will be collected by sites and may be supplemented by a centralized telephone 
call center (and email) via trained personnel at the Duke Clinical Research Institute. Participants may 
also be contacted by the site and/or study team at other timepoints for study issues such as suspected 
device malfunction or nonadherence with the Bodyport Cardiac Scale. 
 
Patients eligible for the study will have HF and a prior history of hospitalization for acute 
decompensated HF. A history of clinical HF will be confirmed by site investigators. To ensure that a 
broad population of patients is enrolled, there will be limited additional inclusion and exclusion criteria. 
The participant population is described in more detail in Section 5 below. 
 
All patients will consent for longitudinal follow-up. This will include remote follow-up visits as well as 
access to clinical records to evaluate for future clinical events. The remote follow-up visits will place a 
minimal burden on patients and sites and be limited to assessments for suspected clinical events. All 
patients will consent to release of medical records regarding HF history and suspected clinical events. 
Based on site- and participant-reported events, medical records for possible clinical events will be 
collected. Possible clinical events will be reviewed and adjudicated by a clinical events committee using 
standardized definitions. The committee members will be blinded to sensor and algorithm data. 
 
Training on device use will be provided to patients and daily utilization of the Bodyport Cardiac Scale will 
be requested. Device sensor data will be uploaded remotely and analyzed on an ongoing basis 
throughout the study. Patients, study teams, and treating clinicians will be blinded to the investigational 
sensor data other than basic information that is currently available through other devices including 
weight, heart rate and leg edema status. There will be no attempt to utilize the study data to influence 
clinical practice. 
 
4.2 SCHEDULE OF EVENTS 
 
Table 2. SCALE-HF 1 Schedule of Events 
 
Baseline Visit 
Follow-up Visits 
Eligibility criteria 
X 
 
Informed consent 
X 
 
Demographics a 
X 
 
Laboratory evaluations b 
X 
 
Electrocardiogram 
X 
 

Relevant medical history c 
X 
 
Implantable device data d 
 
X 
HF outcomes e 
 
X 
Arrhythmic events requiring 
hospitalizations f 
 
X 
a Includes date of birth, sex, race, ethnicity 
b Includes most recent basic metabolic panel (sodium, potassium, blood urea nitrogen, serum creatinine) and natriuretic 
peptide levels, B-type natriuretic peptide (BNP) or N-terminal pro-BNP. Where available will collect right heart cath data.  
c Includes heart failure history including last assessment of left ventricular ejection fraction 
d Patients with cardiac implantable electronic devices including pulmonary artery sensors and implantable cardioverter 
defibrillators will provide routine interrogation data 
e Hospital readmissions and all-cause mortality. 
f Hospitalization event or treatment for ventricular arrhythmia (shock by defibrillator) 
5. STUDY POPULATION 
5.1 INCLUSION CRITERIA 
 
Participants eligible for inclusion in this study must fulfill all of the following criteria: 
1. Provide informed consent before trial enrollment 
2. Age ≥ 18 years  
3. A diagnosis of symptomatic HF including a worsening HF event in the preceding 12 months. 
Worsening HF events will be determined by local clinician-investigators and will typically include 
the following: a) HF symptoms (eg, dyspnea, fatigue); b) HF signs (eg, elevated jugular venous 
pressure, peripheral edema), or laboratory/imaging evidence of HF (eg, pulmonary congestion 
on chest x-ray, elevated natriuretic peptide levels) during the event, and treatments targeting 
acute HF (eg, intravenous diuretics, vasodilators, or inotropes). 
 
5.2 EXCLUSION CRITERIA 
 
Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional 
exclusions may be applied by the investigator, in order to ensure that the trial population will be 
representative of all eligible participants. 
1. Weight > 170 kg 
2. Use of chronic inotropic therapy 
3. Prior heart transplant or currently listed for heart transplant 
4. Current or planned left ventricular assistance device  
5. Chronic kidney disease requiring chronic dialysis 
6. Unknown left ventricular ejection fraction (LVEF). The LVEF should be based on the most recent 
local measurement using echocardiography, multigated acquisition scan, computed tomography 
scanning, magnetic resonance imaging, or ventricular angiography. Patients with preserved and 
reduced LVEF will be permitted in the study though enrollment may be capped to ensure no 

more than approximately 2/3 of the total enrollment includes patients with preserved or 
reduced LVEF. 
7. Terminal illness other than HF, such as malignancy, or with a life expectancy of less than 1 year 
as determined by the enrolling clinician-investigator 
8. Unable to participate in longitudinal follow-up including daily use of the Bodyport Cardiac Scale. 
Patients must be able and willing to stand independently on the Bodyport Cardiac Scale daily. 
 
6. STUDY VISITS AND ACTIVITIES 
6.1 SCREENING AND ENROLLMENT 
 
Patients will be identified from outpatient clinic logs as well as current admission panels. Patients 
previously included in clinical trials will also be screened for candidacy. Eligible candidates will be 
enrolled from an outpatient setting or an inpatient setting. Enrollment will be capped to ensure that no 
more than approximately 2/3 of the total enrollment will be at the time of hospital discharge or from 
the outpatient setting. 
 
Prior to screening activities, each patient will be given an opportunity to ask questions and to 
understand the details of study participation, including risks and benefits. This consent process will be 
documented in the patients’ source documents and evidenced by the patient signing the informed 
consent form (ICF). All patients will consent to release of medical records regarding HF history and 
suspected clinical events. Informed consent will be obtained either in person or via e-consent according 
to respective institutional policies.  
 
After signing the ICF, each patient will be assigned a unique identifier number that will be used on all 
documentation.  
 
Screening data will be collected after informed consent is signed. The Screening evaluations include: 
● Informed Consent 
● Inclusion/Exclusion Criteria 
● Demographics 
● Medical history  
● Most recent physical examination, biomarkers (NT-proBNP, basic metabolic panel) and vital 
signs measurements 
● Current medications 
● Recent laboratory data including renal function and natriuretic peptide values  
If measurement of any of the above assessments does not occur in the normal course of patient care, 
clinical practice should not be changed to accommodate collection of additional data. 
 
Following enrollment, the patient will be provided with the study device and receive training in person 
or remotely on its use from study coordinators or company representatives. 
1. Outpatient-  Enrollment can occur in person or remotely. Scale will be provided upon clinic visit 
or shipped to patient directly after the appointment  

2. Inpatient- Patient is enrolled prior to discharge. Scale will be provided prior to discharge or 
shipped by Bodyport Inc. to patient directly after the discharged 
 
 
6.2 SURVEILLANCE/FOLLOW UP 
 
Follow-up will occur remotely at 6 weeks, 3 months and then every 3 months until the end of the study.  
Follow-up will occur via telephone interviews by trained personnel by individual participating sites. This 
approach will ensure the consistency and quality of data collection and minimize loss to follow-up. At 
each interview, participants will be asked to report any encountered clinical events.  
 
Routine data collection at each follow up timepoint will include: 
● Possible clinical event including those that occur outside of the enrolling health system such as 
hospitalization, emergency room visit or clinic visit with IV diuretic administration 
 
Based on participant-reported events, clinical data for rehospitalizations, emergency department visits, 
and worsening heart failure related clinic visits will be obtained and submitted for review. As an 
additional mechanism to safeguard against under-reporting of events, sites will conduct medical record 
queries at 6 weeks, 3 months and then every 3 months until the end of the study enrollment to screen 
for hospitalizations or procedures. 
 
Patients may also be contacted by the site and/or study team including the sponsor and coordinating 
center for suspected device malfunction or nonadherence with the Bodyport Cardiac Scale. 
Nonadherence is defined as device non-use for 3 days or more. Patients will be potentially contacted 
using email, phone calls or text messaging to provide reminders to use the scale. Should non-use 
continue beyond 4 days the patient may be contacted by a phone call to explore potential problems 
with the technology or explore whether an event might have occurred.  
 
Upon study discontinuation the patients are asked to return the scale to the company and are provided 
with a return shipping label.  
7. COMPENSATION 
Participants will not receive any compensation for participating in this study. 
 
8. COSTS 
Participants will not incur any additional costs due to study participation. Patients or their insurance 
company will be required to pay for all expenses related to regular care such as outpatient visits and 
other hospital care.  
 

9. SAFETY MONITORING 
No safety related concerns are expected with the non-invasive scale. No safety specific / adverse 
endpoints are defined 
 
10. STATISTICAL METHODS AND DATA ANALYSIS 
10.1 STATISTICAL AND ANALYTICAL PLANS 
 
The Bodyport Cardiac Scale captures various physiological signals including an electrocardiograph, an 
impedance plethysmograph, and a ballistocardiograph. These raw signals will be filtered and 
interpolated prior to feature extraction and model validation. Regions with motion artifacts or noise will 
be identified and removed. Ensemble average waveforms will be constructed from the real-time signals. 
Specific characteristic features will be identified on the averaged waveforms. Temporal and amplitude-
based biomarkers will be extracted from the identified features within and across each averaged 
waveform. These features and biomarkers will be assessed longitudinally by constructing trends 
consisting of multiple measurements and identifying statistically significant changes over time. Some of 
the key features being explored in this study are: weight, heart rate, heart rate variability, peripheral  
impedance, body fluid, balance, stroke volume, cardiac output, pre-ejection period, left ventricular 
ejection time, as well as the amplitude and timing of characteristic features on the IPG, ECG, and BCG 
signals. A focus on these specific features is driven by prior research demonstrating clinical relevance to 
cardiovascular function and heart failure status. 
 
During analysis, various methods will be implemented to select signal features that demonstrate a 
meaningful association with HFEs. Those features most strongly correlated to HFEs will be combined 
into a model and associated alert algorithm. The development of the model may use a combination of 
techniques, including multivariate regression and machine learning (e.g. support vector machines, 
clustering, decision trees, Bayesian networks). Models will be evaluated and optimized based on their 
sensitivity and specificity to detect heart failure events. 
 
10.2 INTERIM ANALYSIS 
Throughout the study, enrollment rates, heart failure event prevalence, and adherence will be analyzed. 
 
Additionally, at 100 enrolled patients with approximately 90 day follow up, an interim analysis may be 
performed. Data will be shared with Bodyport for statistical analysis and possible publication. Bodyport 
will use the scale biomarker data to validate a model that reflects changes in patient status. The model 
will use intra-patient biomarker trends to detect meaningful deviations from a patient’s baseline state.  
10.3 SAMPLE SIZE 
Data derived from this study will add to the model development aims of the Bodyport Cardiac Scale. This 
study is statistically powered to detect approximately 75 primary endpoints which will approximate to 
about 300 enrolled patients. An event rate of 75 equates to an approximate rate of 25% at 6 months. 
Given that this study is a development study however additional events may be required to derive the 
predictive algorithm. 
 

10.4 Adjudication Committee 
The Adjudication Committee consists of trained clinicians, who will, when an event occurs, review the 
medical records to confirm that the event meets the criteria of the trial endpoints. 
 
11. PROCEDURES AND INSTRUCTIONS 
11.1 PROTOCOL AMENDMENTS AND OTHER CHANGES IN STUDY CONDUCT 
         PROTOCOL AMENDMENTS  
Any substantive changes will be made as formal amendments to the protocol and will be submitted for 
appropriate review by an institutional review board (IRB). 
 
Any change or addition to this protocol requires a written protocol amendment that must be approved 
by Bodyport Inc. and the Investigator before implementation. Amendments affecting the scope of the 
investigation, or the scientific quality of the study require additional approval by the IRB. Examples of 
amendments requiring such approval are: 
1. 
A significant change in the study design (e.g., duration of follow up) 
2. 
A change in patient inclusion and exclusion criteria  
 
Protocol changes affecting only administrative aspects of the study do not require formal protocol 
amendments or IRB approval, but the IRB must be kept informed of such administrative changes.  
 
 
11.2 RECORDING OF DATA, DOCUMENTATION, AND RETENTION OF DOCUMENTS 
Data will be stored and evaluated in such a way as to guarantee subject confidentiality in accordance 
with the legal stipulations applying to confidentiality of data. All study records must be available for 
inspection by the Sponsor, its authorized representatives, and regulatory authorities. 
 
Data on subjects collected on CRFs during the study will be documented in an anonymous fashion and 
the subject will only be identified by the study number and by initials if also required. If, as an exception, 
it is necessary for safety or regulatory reasons to identify the subject, both Bodyport Inc. and the 
Investigator are bound to keep this information confidential.  
 
The Investigator must maintain source documents for each subject in the study, consisting of all 
demographic and medical information, and must keep a copy of the signed ICF. The subject’s clinical 
source documents (usually defined by the project in advance to record key efficacy/safety parameters 
independent of the CRFs) would include but are not limited to the subject’s hospital/clinic records, 
physicians’ and nurses’ notes, appointment book, original laboratory reports, ECG, pathology and special 
assessment reports and signed ICFs. All information on the CRFs must be traceable to these source 
documents in the subject's file. Data without a written or electronic record will be defined before study 
start and will be recorded directly on the CRFs, which will be documented as being the source data.  
 
Essential documents defined in the ICH Guidance on Good Clinical Practice (ICH E6) and listed below, 
must be retained by the Investigator for as long as needed to comply with national and international 
regulations. The Sponsor will notify the Investigator(s)/institution(s) when the study-related records are 
no longer required. The Investigator agrees to adhere to the document retention procedures by signing 
the protocol.  

 
Essential documents include: 
1. 
IRB approvals for the study protocol and all amendments 
2. 
All source documents and laboratory records 
3. 
CRF copies  
4. 
Subjects' ICFs (with study number and title of study) 
 
 
11.3 AUDITING PROCEDURES 
Investigator understands that source documents for this study must be made available to appropriately 
qualified personnel from the Sponsor or its designees, to the IRB, and/or to health authority inspectors 
after appropriate notification. The verification of the CRF data must be by direct inspection of source 
documents. The Sponsor conducts audits of clinical research activities in accordance with internal SOPs 
to evaluate compliance with the principles of GCP. A regulatory authority may also wish to conduct an 
inspection (during the study or even after its completion). If an inspection is requested by a regulatory 
authority, the Investigator must immediately inform the Sponsor that this request has been made. 
 
 
11.4 PUBLICATION OF RESULTS 
An integrated clinical and statistical report will be prepared at the completion of the treatment period. 
However, it is intended that the results of the study will be included on http://clinicaltrials.gov and 
published and/or presented at scientific meetings.  
 
 
11.5 DISCLOSURES AND CONFIDENTIALITY 
By signing this protocol, the Investigator agrees to keep all information provided by Bodyp     ort, Inc. in 
strict confidence and to request similar confidentiality from his/her staff and the IRB. The information 
provided by Bodyport Inc. to the Investigator may not be disclosed to others without direct written 
authorization from Bodyport Inc., except to the extent necessary to obtain informed consent from 
subjects who wish to participate in the study. 
The Investigator must assure that subjects’ anonymity will be maintained and that their identities are 
protected from unauthorized parties. The Investigator should keep a subject enrollment log relating 
codes to the names of subjects. The Investigator should maintain documents not for submission to the 
Sponsor, (e.g., subjects’ signed consent forms), in strict confidence. 
 
Data use agreements or contracts will be executed with each participating site in addition to the 
applicable institutional approvals prior to any participating site investigator sending patient/subject data 
for this study. 
 
12. ETHICS AND GOOD CLINICAL PRACTICE 
This study must be carried out in compliance with the protocol and:  
● ICH Guidance on Good Clinical Practice (ICH E6)  
● World Medical Association, Declaration of Helsinki 
 

12.1 INSTITUTIONAL REVIEW BOARD AND ETHICS 
Each participating institution will submit this protocol and their ICF for IRB approval prior to starting the 
study. The Investigators will not begin any study subject activities until approval from the IRB has been 
documented and provided as a letter to the Investigator. Before implementation, the Investigators will 
submit to and receive documented approval from the IRB of any modifications made to the protocol or 
any accompanying material to be provided to the subject after initial IRB approval, with the exception of 
those necessary to reduce immediate risk to study subjects. 
 
12.2 INFORMED CONSENT 
The Investigator must explain to each subject the nature of the study, its purpose, the procedures 
involved, the expected duration, the potential risks and benefits involved and any discomfort it may 
entail. Each subject must be informed that participation in the study is voluntary, that he/she may 
withdraw from the study at any time, and that withdrawal of consent will not affect his/her subsequent 
medical treatment or relationship with the treating physician.  
This informed consent should be given by means of a standard written statement, written in 
nontechnical language. The subject should read and consider the statement before signing and dating it, 
and should be given a copy of the signed document. No subject can enter the study before his/her 
informed consent has been obtained. The ICF must be submitted by the Investigator for IRB approval. 
 
12.3 DECLARATION OF HELSINKI 
The Investigator must conduct the study in accordance with the principles of the current version of the 
Declaration of Helsinki. Copies of the Declaration of Helsinki and amendments will be provided upon 
request or can be accessed via the website of the World Medical Association at 
http://www.wma.net/en/30publications/10policies/b3/index.html 
 
13. STUDY DISCONTINUATION 
All sites reserve the right to discontinue the study at any time. The Sponsor reserves the right to 
terminate the study in its entirety or at a specific study center at any time and as specified in the clinical 
study agreement. 
 
 
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