A Prospective Study of Endoscopic Ultrasound Shear Wave Elastography for Assessment of Liver Fibrosis
Phase: NA
Conditions: Chronic Liver Disease, Advanced Fibrosis, Advanced Cirrhosis
Sponsor: Mayo Clinic

 
 
A Prospective Study of Endoscopic Ultrasound 
Shear Wave Elastography for Assessment of 
Liver Fibrosis 
 
NCT05097963 
 
6/1/2021 

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CONFIDENTIAL 
 
Study Title: A Prospective Study of Endoscopic Ultrasound Shear Wave Elastography 
for Assessment of Liver Fibrosis 
 
Principal Investigator: 
 
 
 
 
 
Co-Investigator: 
Vinay Chandrasekhara, MD 
Division of Gastroenterology and Hepatology 
Department of Medicine 
Mayo Clinic 
 Rochester, MN 55905 
 
 
 
Funding Sponsor: 
Investigator-Funded 
 
 
Protocol Number: (IRBe) 
PLM MSR:    
 
21-003779  
2021-304355-H01 
 
 
 
 
 
 
Initial version: 6/1/2021 Version (1.0)  
Revised: 
 
 
 
 

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Protocol Investigator Signature Page   
   
STUDY TITLE:  
  
A Prospective Study of Endoscopic Ultrasound Shear Wave 
Elastography for assessment of liver fibrosis   
PROTOCOL VERSION:  
  
 01/JUN/2021 Version (1.0)  
  
STUDY CENTER:    
                                                                            
(Print name of study center)  
   
I, the undersigned, have read and understand the protocol specified above and agree on its content. I agree to 
perform and conduct the trial as described in the protocol and in accordance with applicable laws and regulations. 
In addition, when applicable, I agree to enlist sub- investigators who also agree to perform and conduct the trial 
as described in the protocol.  
   
   
   
   
   ________________________________________________________________________                                                   
 
Principal/Coordinating Investigator (Print Name)  
Date  
 
 
 
 
 
_________________________________________________________________ 
  
  
                                   
Principal/Coordinating Investigator (Signature)    
Date  
   
 
 
 

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Table of Contents 
STUDY SUMMARY ............................................................................................................................................ 5 
1 
INTRODUCTION ...................................................................................................................................... 6 
1.1 
BACKGROUND ...................................................................................................................................... 6 
1.2 
INVESTIGATIONAL DEVICE ................................................................................................................... 6 
1.3 
CLINICAL DATA TO DATE .................................................................................................................... 6 
1.4 
STUDY RATIONALE AND RISK ANALYSIS (RISKS TO BENEFITS RATIO) ................................................ 6 
1.4.1 
Study Rationale ............................................................................................................................... 6 
1.4.2 
Anticipated Risks ............................................................................................................................ 7 
1.4.3 
Potential Benefits............................................................................................................................ 7 
1.5 
ANTICIPATED DURATION OF THE CLINICAL INVESTIGATION ................................................................ 7 
2 
STUDY OBJECTIVES ............................................................................................................................... 7 
3 
STUDY DESIGN ........................................................................................................................................ 8 
3.1 
GENERAL DESIGN ................................................................................................................................ 8 
3.2 
9 
FIGURE 1: STUDY DESIGN .................................................................................................................................. 9 
3.3 
VISIT DESCRIPTIONS .......................................................................................................................... 10 
3.3.1 
Visit 1 ............................................................................................................................................ 10 
3.3.2 
Visit 2 ............................................................................................................................................ 10 
3.3.3 
Follow-Up Analysis ...................................................................................................................... 10 
3.4 
PRIMARY SAFETY ENDPOINTS ............................................................................................................ 10 
4 
SUBJECT SELECTION, ENROLLMENT AND WITHDRAWAL.................................................... 11 
4.1 
INCLUSION CRITERIA ......................................................................................................................... 11 
4.2 
EXCLUSION CRITERIA ........................................................................................................................ 11 
4.3 
SUBJECT RECRUITMENT, ENROLLMENT AND SCREENING .................................................................. 11 
4.4 
EARLY WITHDRAWAL OF SUBJECTS................................................................................................... 12 
4.4.1 
When and how to Withdraw Subjects ........................................................................................... 12 
4.4.2 
Data Collection and Follow-up for Withdrawn Subjects ............................................................. 12 
5 
STATISTICAL PLAN .............................................................................................................................. 12 
5.1 
SAMPLE SIZE DETERMINATION .......................................................................................................... 12 
5.2 
STATISTICAL METHODS ..................................................................................................................... 14 
5.3 
SUBJECT POPULATION(S) FOR ANALYSIS ........................................................................................... 14 
6 
SAFETY AND ADVERSE EVENTS ...................................................................................................... 14 
7 
DATA HANDLING AND RECORD KEEPING ................................................................................... 15 
7.1 
CONFIDENTIALITY.............................................................................................................................. 15 
7.2 
SOURCE DOCUMENTS......................................................................................................................... 15 
7.3 
RECORDS RETENTION ........................................................................................................................ 16 
8 
STUDY MONITORING, AUDITING, AND INSPECTING ................................................................ 16 
8.1 
STUDY MONITORING PLAN ................................................................................................................ 16 
8.2 
AUDITING AND INSPECTING ............................................................................................................... 17 
9 
ETHICAL CONSIDERATIONS ............................................................................................................. 17 
10 
STUDY FINANCES ................................................................................................................................. 17 
10.1 
FUNDING SOURCE .............................................................................................................................. 17 
11 
PUBLICATION PLAN ............................................................................................................................ 17 

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12 
REFERENCES ......................................................................................................................................... 18 
13 
ATTACHMENTS ...................................................................... ERROR! BOOKMARK NOT DEFINED. 
 
 
LIST OF ABBREVIATIONS 
EUS 
MRE 
AE 
Endoscopic Ultrasound 
Magnetic Resonance Elastography 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
DSMB 
Data and Safety Monitoring Board 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
IRB 
Institutional Review Board 
PHI 
Protected Health Information 
PI 
Principal Investigator 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SOE 
Schedule of Events 
SOP 
Standard Operating Procedure 
E 
Elastic Modulus 
 Vs 
 
 
             Shear wave velocity 
 VsN 
 
 
             Reliability Index  
 IQR/M 
 
 
 Interquartile Range/Median  
 
 
 
 

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Study Summary 
Title 
A Prospective Study of Endoscopic Ultrasound Shear Wave 
Elastography for assessment of liver fibrosis 
Running Title 
EUS shear wave elastography VS MRE 
Title Acronym 
EUS vs MRE 
IRB Protocol 
Number 
21-003779 
Phase 
Prospective comparative study  
Methodology 
Subjects who are eligible will undergo EUS for clinical indications. 
After completion of EUS, subjects will undergo subsequent MR 
Elastography if not already performed for clinical purposes. EUS 
Shear wave measurements will be studied to determine diagnostic 
accuracy when compared to MR Elastography.  
Overall Study 
Duration 
6 months Recruitment and Active study execution, 3 months 
analysis and 3 months publication. Total: 12 months  
Subject 
Participation 
Duration 
Up to 60 days screening prior to study procedure, and up to 60 days 
post procedure to follow-up MRE.   
Objectives 
To assess the diagnostic accuracy of EUS shear wave elastography 
in liver fibrosis staging in both normal subjects and subjects with 
advanced liver fibrosis/cirrhosis  
Number of Subjects 
Fifty (50)   
Diagnosis and Main 
Inclusion Criteria 
Subjects over 18 years of age who are scheduled to undergo 
endoscopic ultrasound procedure as part of clinical care. 
Study Device 
EUS shear wave elastography  
Reference Imaging 
Modality 
Magnetic resonance elastography (MRE) 
Statistical 
Methodology 
All continuous variables will be expressed as mean and standard 
deviation. Categorical variables will be expressed as percentages. 
Multivariate analysis will be performed.  
 
 

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1 Introduction 
 
This document is a clinical research protocol relating to the prospective study on endoscopic 
ultrasound (EUS) shear wave elastography in assessment of liver fibrosis. The described 
study will be conducted in compliance with this protocol, applicable United States 
government regulations and Mayo Clinic policies and procedures.  
1.1 
Background 
 
Shear wave elastography (SWE) uses shear waves to assess tissue elasticity in a non-invasive 
fashion. This technology has been incorporated into conventional trans-abdominal 
ultrasonography to evaluate for liver stiffness, especially in patients with suspected chronic 
liver disease. Endoscopic assessment of the liver is routinely performed during endoscopic 
ultrasound (EUS). Recent software package enhancements have allowed for the option of 
shear wave measurement during EUS procedures. To date, there is little to no literature on 
the performance of EUS SWE and its applicability in the assessment of liver fibrosis in the 
clinical setting. Therefore, we wish to determine the applicability of EUS SWE and evaluate 
its diagnostic accuracy compared to magnetic resonance imaging elastography, which is 
widely utilized to determine the presence of advanced fibrosis/cirrhosis in current clinical 
practice.  
 
1.2 
Investigational Device 
 
EUS shear wave is available commercially, through a software package upgrade on the 
existing EUS machine. The Olympus Aloka Arietta 850 EUS processor and shear wave 
elastography software package are FDA-approved devices that have been purchased for 
clinical purposes and is being used in clinical practice. Shear wave measurements are 
obtained by the press of a button on the EUS machine to switch on the SWE software and 
measurements obtained.   
 
1.3 
Clinical Data to Date 
 
Currently there is no available literature that systemically evaluates the performance of EUS 
shear wave elastography. Our study would provide the first prospective, comparative 
evaluation of EUS SWE with MR elastography, which is a widely adopted non-invasive 
imaging modality utilized for liver fibrosis assessment.  
1.4 
Study Rationale and Risk Analysis (Risks to Benefits Ratio) 
1.4.1 Study Rationale 
 

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Patients with chronic liver disease who are suspected to have advanced fibrosis will often 
undergo endoscopy for a variety of reasons (e.g. variceal screening). If successful and 
reliable, EUS-SWE will enable us to provide single session, comprehensive assessment of 
the liver including fibrosis staging and screening for complications of advanced liver disease 
such as gastroesophageal screening and liver cancer. The perceived practical advantages 
include reduced number of appointments, thereby confers cost and time benefits for the 
patients. Furthermore, EUS obviates the need for shear waves to travel through abdominal 
wall and visceral adiposity, hence provides unobstructed views of the liver in which accurate 
measurements can be obtained. This is particularly beneficial in many patients with non-
alcoholic fatty liver disease (NAFLD) associated with significant underlying obesity (e.g. 
BMI > 35), where other imaging modalities often under-performs due to BMI limitations.   
 
1.4.2 Anticipated Risks 
 
There would be no additional anticipated risks associated with EUS shear wave elastography. 
Patients will undergo EUS procedure as clinically indicated and therefore would be subjected 
to the standard procedural risks associated with performing EUS.  
 
1.4.3 Potential Benefits 
 
If successful and reliable, EUS-SWE will enable us to provide single session, comprehensive 
assessment of the liver including fibrosis staging and screening for complications of 
advanced liver disease such as gastroesophageal screening and liver cancer. The perceived 
practical advantages include reduced number of appointments, thereby confers cost and time 
benefits for the patients.  
 
1.5 
Anticipated Duration of the Clinical Investigation 
 
The overall duration of the study is estimated to be six to twelve months. There will be no 
planned follow up at the completion of the MRE. 
 
 
2 Study Objectives 
 
2.1 Primary Objective 
 
To evaluate the diagnostic performance of EUS shear wave elastography in the assessment of 
liver fibrosis compared to MR elastography.  
 

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2.2 Secondary Objective 
 
1. Explore the predictive value of EUS shear wave elastography in prognosticating 
patients with chronic liver disease and its complications.  
 
3 Study Design 
3.1 
General Design 
 
This is a prospective, paired study. Study subjects who are scheduled to undergo EUS at Mayo 
Clinic will be identified through Epic. Chart review will be performed including review of 
prior imaging, medical history, and laboratory results as available in Epic to determine study 
eligibility. Subjects without history of chronic liver disease (screened by low FIB-4 score) and 
those with known advanced fibrosis/cirrhosis will be eligible for the study. Eligible study 
subjects will then be contacted either before, or at the time of their endoscopy procedure to 
discuss study participation. All subjects will then receive standard clinical care based on the 
indication for the EUS procedure. During the EUS procedure, study subjects with undergo 
shear wave measurements obtained in a non-invasive manner as part of the endosonographic 
evaluation of the liver. 10 measurements (including shear wave velocity (Vs), elastic modulus 
(E)) will be obtained for point SWE (pSWE). Measurements will be obtained from both left 
and right lobes of liver unless technically infeasible to do so. Study subjects will then undergo 
a paired MR elastography (same day or at later date) after completion of EUS and only if 
consistent and reliable shear wave measurements were obtained (e.g., VsN > 70%(reliability 
index of each measurement expressed in percentages), IQR/M (interquartile range/ Median) is 
<15% for Vs and <30% for E). Enrolled study subjects who had undergone a previous MRE 
(within 6 months of enrollment) would be eligible for the study, without the need to undergo 
further research MRE. After completion of MR elastography, the subjects will then continue 
through their routine clinical care and will not be followed up by research staff. The expected 
duration of subject participation is anticipated to begin at the time of study enrollment and 
terminate after completion of MR elastography. There will be no additional follow up.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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3.2 
 
Figure 1: Study Design 
 
 
 
 
 
 

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Table 1: Schedule of Events (SOE) 
 
 
Baseline 
Screening & 
Enrollment 
Visit 1 
Days -180 to 0 
Accrual: Study 
Intervention 
Visit 2 
Day 0 
 
Follow up 
Visit 3 
Days 0 to 60 
Inclusion/Exclusion 
X 
 
 
EUS and Shear wave 
Elastography 
 
X 
 
MRE 
X* 
 
X* 
 
*MRE only required to be conducted once. Patients undergoing MRE for clinical purposes 
within the study timeframe can be recruited using the clinically performed MRE result.  
3.3 
Visit Descriptions 
3.3.1 
Visit 1 
Eligible study participants will be screened, approached and consented for the study. The 
screening and enrollment process may be performed remotely. 
 
3.3.2 Visit 2 
3.3.2.1 The participant will then undergo EUS procedure as clinically indicated. The shear 
wave measurements will be obtained during EUS. Study subjects will undergo MR 
elastography if no results within the previous 6 months are available. Subject 
participation is deemed complete at the end of MRE.  
3.3.3 
Follow-Up Analysis 
Accuracy and efficacy of EUS shear wave elastography in assessing liver fibrosis when 
compared to MR elastography.  
3.4 
Primary Safety Endpoints 
 
There are no specific primary safety endpoints pertaining to the study as EUS shear wave and 
MR elastography are non-invasive investigations. There is no investigational device involved 
in this study.  
 
 

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4 Subject Selection, Enrollment and Withdrawal 
 
All patients who are undergoing EUS procedures may be eligible for the study. Patients with 
an established history of chronic liver disease with associated advanced fibrosis/cirrhosis will 
be of particular interest to the study.  
It is anticipated that we will screen up to 250 subjects and enroll 50 subjects to the study.  
 
4.1 
Inclusion Criteria 
 
1. Adults over 18 years of age who are undergoing EUS procedures. 
2. Subjects with history of chronic liver disease, advanced fibrosis, or cirrhosis. 
3. Subjects without any history of chronic liver disease. 
4. Subjects able to give appropriate consent to the study. 
 
4.2 
Exclusion Criteria 
1. Subjects who may have MRI-incompatible metal implants/devices. 
2. Subjects with severe claustrophobia who may not tolerate MR elastography. 
3. Subjects with unreliable EUS-SWE measurements.  
 
4.3 
Subject Recruitment, Enrollment and Screening 
 
 
Potential subjects will be identified by the study team referencing the procedure and surgery 
calendars for upcoming procedures. If patients are scheduled for an EUS, they may be 
contacted by study staff prior to their procedure, to gauge interest. 
Potential subjects may also be identified by physician referral. These patients would also be 
contacted prior to their procedure to gauge interest. 
Outpatient subjects may be approached about the opportunity by phone, email, portal, or in-
person to discuss the study details. Inpatients may be approached by phone or in their room as 
allowed by the charge nurse. An electronic or paper copy of the consent may be provided via 
these methods, prior to consent. to discuss and address any questions. 
 
Recruitment will take place at the pre-procedural area prior to the procedure, or study team 
will reach out via email or phone to convey informed consent information which may include 
giving a copy of the consent form for review. Consenting and enrolment of patients on day of 
procedure will occur in a private room on the procedural floor prior to the procedure.  These 
rooms house only one patient at a time and closing the door and blinds will eliminate the chance 
of individuals outside the room from hearing or witnessing the informed consent process. 30 
minutes will be provided for discussion. Minimum 30 minutes will be provided between 

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discussion and decision allowing patients time to consider and talk with friends and/or family. 
Patients will have access to any glasses and/or hearing aids. 
 
Investigators and/or study team will come to the potential subjects to explain the details of the 
study and obtain written informed consent and complete the questionnaires. These may also 
be collected digitally through Ptrax via Remote Consenting and either a video meeting or 
telephone meeting prior to signing the ICF. Subjects will have time ample time to learn about 
our study and decide if they want to enroll prior to consent. 
 
The consent visit will occur through a video or phone consult with the subject and a witness if 
the subject is not able to physically sign consent. Once a time for the consent is agreed upon, 
the consent will be sent via email. The subject will be reminded not to sign the form prior to 
the consent appointment. The identity of the subject will be confirmed through the video or 
phone connection, as well as clinic number, name, and birthdate. A 30- minute consent 
appointment will be scheduled. Additional time can be added as needed. After the subjects’ 
questions are answered and if the subject agrees, the form will be signed electronically. 
 
Documentation of informed consent will involve the use of the Remote 
Electronic Consent technology. The subject may print or electronically 
save the form through DocuSign or from their patient portal or the subject 
may contact the study team to provide a copy of the form. Note: If the 
subject prefers not to use the Electronic Consent technology, the study 
team will provide a paper consent form for signature either in person or by mail. 
 
4.4 
Early Withdrawal of Subjects 
4.4.1 When and how to Withdraw Subjects 
 
The subjects will undergo EUS shear wave elastography and MRE in a sequential order, 
unless subjects had undergone previous MRE. If EUS shear wave measurements are 
unreliable (i.e., VsN < 70%). Then subjects will be withdrawn from the study and therefore 
will not proceed to undergo MRE, or to be included in the final analysis.  
 
4.4.2 Data Collection and Follow-up for Withdrawn Subjects 
 
Withdrawn subjects will be recorded in the study record in order to calculate the withdrawal 
rate. There will be not further utilization of any subject related data.  
 
5 Statistical Plan 
5.1 
Sample Size Determination 
 

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The hypothesis is at EUS-SWE is non-inferior to MRE at differentiating (“diagnosing”) 
cirrhosis vs those without fibrosis.  
 
Using the pooled AUC above for MRE of 0.972, and data from our preliminary analysis that 
EUS-SWE had an AUC of 0.89., a sample size of 50 would give us 99% power and a sample 
size of 25 gives us 91% power. We anticipate screening up to 250 potential study 
participants.  
 
 
 
 

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5.2 
Statistical Methods  
 
Descriptive Statistics 
Baseline values for demographic, clinical, and outcome will be tabulated for the study 
subjects.  Continuous variables will be expresses as mean and standard deviation. Categorical 
variables will be expressed as percentages.  
 
Analytical Statistics 
The obtained shear wave measurements will be compared to MR elastography measurements 
to determine the AUC of EUS-SWE using MRE serving as the gold standard. Logistic 
regression will be used to generate ROC curves, and exploratory multivariable analyses using 
baseline differences in each group and other important clinical factors will be performed to 
identity confounders and interactions during the exploratory sensitivity analyses. 
 
Handling of Missing Data 
Subjects in which EUS shear wave measurements are unreliable (i.e., VsN < 70%) will not 
proceed to undergo MR elastography and will be excluded from the study, therefore will not 
be part of the statistical analysis. However, the subject will be recorded for the study to 
determine the rate of unreliable EUS shear wave measurements.   
 
5.3 
Subject Population(s) for Analysis 
 
Subjects who have completed both EUS shear wave elastography and MR elastography will 
be included in the analysis.  
 
 
 
6 Safety and Adverse Events 
 
The EUS Shear wave elastography is being performed clinically and the safety and adverse 
events are not different from those inherent to the EUS procedure. Shear wave measurements 
typically require 5-10 minutes of procedural time. 
There are no expected clinical adverse events for the study as the study intervention (MRE) 
is a non-invasive scan without any published safety concerns. Therefore, this study will not 
track any adverse events.  
 
Definitions 
 
Adverse Effect (Event) 
Any untoward medical occurrence in a subject involved in clinical study of an investigational 
device; regardless of the causal relationship of the problem with the device or, if applicable, 
other study related treatment(s). 
 

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Life-threatening adverse effect: Any adverse effect that places the subject, in the view of 
either the investigator or the sponsor, at immediate risk of death from the effect as it 
occurred.  It does not include a reaction that, had it occurred in a more severe form, might 
have caused death. 
 
Serious adverse effect: An adverse effect is considered “serious” if, in the view of either the 
investigator or the sponsor, it results in any of the following outcomes:  
• death  
• a life-threatening AE 
• inpatient hospitalization or prolongation of existing hospitalization 
• a persistent or significant disability/incapacity 
• a congenital anomaly/birth defect. 
 
Unanticipated adverse effect: Any adverse effect, the nature, specificity, severity, or 
frequency of which is not consistent with the risk information in the clinical study protocol or 
elsewhere in the current IDE application. 
 
All inclusion and exclusion criteria are set out and there will be no protocol deviation.  
7 Data Handling and Record Keeping 
7.1 
Confidentiality 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  
Those regulations require a signed subject authorization informing the subject of the 
following: 
• What protected health information (PHI) will be collected from subjects in this study? 
• Who will have access to that information and why? 
• Who will use or disclose that information? 
• The rights of a research subject to revoke their authorization for use of their PHI. 
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by 
regulation, retains the ability to use all information collected prior to the revocation of 
subject authorization.  For subjects that have revoked authorization to collect or use PHI, 
attempts should be made to obtain permission to collect at least vital status (long term 
survival status that the subject is alive) at the end of their scheduled study period. 
7.2 
Source Documents 
 
Source data comprise all information, original records of clinical findings, observations, or 
other activities in a clinical trial necessary for the reconstruction and evaluation of the trial.  
Source data are contained in source documents.  Examples of these original documents, and 
data records include: hospital records, clinical and office charts, laboratory notes, 
memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, 
recorded data from automated instruments, copies or transcriptions certified after verification 

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as being accurate and complete, microfiches, photographic negatives, microfilm or magnetic 
media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at 
medico-technical departments involved in the clinical trial. When applicable, information 
recorded on the CRF shall match the Source Data recorded on the Source Documents. 
 
Data Management 
All data points gathered for the study will remain confidential and only available to 
designated research personnel. The data will be managed using Excel Subject Tracking. 
 
Data Security and Confidentiality 
 
All collected data points and information will be securely stored in Mayo Clinic issued 
laptops, desktops or tablets with password encryption. Only study personnel will have access 
to the study data and information.  
 
 
7.3 
Records Retention 
 
The study team will maintain records and essential documents related to the conduct of the 
study.  These will include subject case histories and regulatory documents. 
 
The study team will retain the specified records and reports during the study and for the longer 
of the following. 
1. As outlined in the Mayo Clinic Research Policy Manual –“Retention of and Access to 
Research Data Policy”
  
 
OR 
 
2. A period of 2 years after the latter of the following two dates: The date on which the 
investigation is terminated or completed, or the date that the records are no longer 
required for purposes of supporting a premarket approval application or a notice of 
completion of a product development protocol. 
 
 
8 Study Monitoring, Auditing, and Inspecting 
8.1 
Study Monitoring Plan 
 
The investigator will allocate adequate time for such monitoring activities. Data safety 
monitoring plan (DSMP) will be completed after the first subject, then at 3 months and then 
annually if required. Delegated study staff will conduct the review. The review will be 
written up as reports and submitted to IRB for further review if required. The Investigator 
will also ensure that the monitor or other compliance or quality assurance reviewer is given 

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access to all the study-related documents and study related facilities (e.g., pharmacy, 
diagnostic laboratory, etc.), and has adequate space to conduct the monitoring visit. 
 
8.2 
Auditing and Inspecting 
The sponsor-investigator will permit study-related monitoring, audits, and inspections by the 
IRB, the monitor, and government regulatory agencies, of all study related documents (e.g., 
source documents, regulatory documents, data collection instruments, study data etc.).  The 
sponsor-investigator will ensure the capability for inspections of applicable study-related 
facilities (e.g., pharmacy, diagnostic laboratory, etc.). 
 
9 Ethical Considerations 
This study is to be conducted according to United States government regulations and 
Institutional research policies and procedures. 
 
This protocol and any amendments will be submitted to a properly constituted local 
Institutional Review Board (IRB), in agreement with local legal prescriptions, for formal 
approval of the study.  The decision of the IRB concerning the conduct of the study will be 
made in writing to the sponsor-investigator before commencement of this study. 
 
All subjects for this study will be provided a consent form describing this study and 
providing sufficient information for subjects to make an informed decision about their 
participation in this study.  This consent form will be submitted with the protocol for review 
and approval by the IRB for the study.  The formal consent of a subject, using the Approved 
IRB consent form, must be obtained before that subject undergoes any study procedure.  The 
consent form must be signed and dated by the subject or the subject’s legally authorized 
representative, and the individual obtaining the informed consent. 
 
 
10 Study Finances 
10.1 Funding Source 
 
This is an investigator-initiated and investigator-funded study.  
11 Publication Plan 
 
The results of the study will be written up and submitted to 
gastroenterology/endoscopy/hepatology journals for publication.  
 
 

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12 References 
 
There is minimal available literature on this topic. We are performing a small pilot study with 
retrospective then prospectively collected EUS shear wave measurements. The preliminary 
results suggest that EUS shear wave carries good diagnostic accuracy in differentiating 
subjects with normal liver stiffness and those with advanced fibrosis/cirrhosis. The results will 
require full statistical analyses. However, our positive observation with the pilot study will 
form the basis of our current comparative study between EUS shear wave and MRE.