Volumetric Laser Endomicroscopy With Intelligent Real-time Image Segmentation (IRIS): a Multi-center Randomized Prospective Study
Phase: NA
Conditions: Barrett's Esophagus Without Dysplasia, Barrett's Esophagus With Dysplasia, Barrett's Esophagus With Low Grade Dysplasia, Barrett's Esophagus With High Grade Dysplasia, Barrett's Esophagus With Dysplasia, Unspecified
Sponsor: Northwell Health

COVER PAGE 
 
Study Title: Volumetric laser endomicroscopy with intelligent real-time 
image segmentation (IRIS): a multi-center randomized prospective study 
 
NCT03814824 
 
Document Version Date: 12-Aug-2019 

Version Date: 08-12-2019 
 
Page 1 of 29 
 
 
RESEARCH PROTOCOL 
 
 
Protocol Title: 
Volumetric laser endomicroscopy with intelligent real-time image 
segmentation (IRIS): a multi-center randomized prospective study 
Principal Investigator: 
Arvind Trindade, MD 
Primary Contact Name: 
Molly Stewart 
Primary Contact Phone: 
516-600-1443 
Primary Contact E-mail: 
Mstewart8@northwell.edu 
Date Revised: 
12-Aug-2019 
IRB Number: 
18-0963 
 
 
Guidelines for Preparing a Research Protocol 
 
Instructions: 
 
• You do not need to complete this document if you are submitting an Application for 
Exemption or Application for a Chart Review.   
• Do not use this template if: 
o  Your study involves an FDA regulated product.  In this case, use the Clinical 
Trial Protocol Template. 
o Your study has a protocol from a sponsor or cooperative group.  In this case, use 
the Protocol Plus.   
o Your study is a registry or repository for data and/or samples,  In this case, use 
Protocol Template – Registry Studies.  .   
• If a section of this protocol is not applicable, please indicate such. 
• Do not delete any of the text contained within this document. 
• Please make sure to keep an electronic copy of this document.  You will need to use it, if 
you make modifications in the future.   
• Start by entering study information into the table above, according to these rules: 
o Protocol Title:  Include the full protocol title as listed on the application. 
o Investigator:  include the principal investigator’s name as listed on the application 
form 
o Date Revised:  Indicate the date at which the protocol was last revised 
o IRB Number:  Indicate the assigned IRB number, when known.  At initial 
submission, this row will be left blank.   
• Once the table information in entered, proceed to page 2 and complete the rest of the 
form. 
 
 
 
 Continue to next page to begin entering information about this study  
 
 

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Page 2 of 29 
 
1.  PREVIOUS STUDY HISTORY 
 
Has this study ever been reviewed and rejected/disapproved by another IRB prior to 
submission to this IRB? 
 
 No  
 Yes −  if yes, please explain:  
 
 
2. BRIEF SUMMARY OF RESEARCH 
• The summary should be written in language intelligible to a moderately educated, 
non-scientific layperson.  
• It should contain a clear statement of the rationale and hypothesis of your study, a 
concise description of the methodology, with an emphasis on what will happen to the 
subjects, and a discussion of the results.  
• This section should be ½ page 
 
 
This is a multi-center prospective randomized clinical trial examining how IRIS 
(Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE 
(Volumetric laser endomicroscopy). Patients will undergo a VLE exam with and 
without IRIS per the standard of care.  All patients regardless of the study 
participation in this study would receive VLE with and without IRIS clinically. 
Thus randomization into a particular order will not require more procedure time. 
They will be randomized into VLE without IRIS first vs VLE with IRIS first.  The 
BUDDY Randomization System provided for use by the Northwell Health 
Biostatistics Unit will be used for this. Randomization will occur before the 
procedure starts. Randomization will be stratified based on prior diagnosis of 
dysplasia. The order the patient is randomized to will be recorded on the case report 
form. There will be concealed allocation as the study coordinator performing the 
randomization will not know the order of the next allocation.  
 
Both VLE and IRIS imaging are being performed as standard of care.  However, 
randomization of the order allows for comparison of the two.  Regions of interest 
(ROI) will be recorded using a full scan and recorded on the case report form.  The 
time to identification of ROIs will also be recorded.  Each group will then cross 
over such that the VLE without IRIS group will then have IRIS turned on ROI will 

Version Date: 08-12-2019 
 
Page 3 of 29 
then be recorded for each group based on full scans.  A consensus ROI will be 
recorded based on the two exams.  Only one ROI per centimeter will be allowed to 
avoid overlapping of laser marks.  In addition VLE without IRIS and IRIS marks 
within 75 frames of each other or 2 hours (on a clock face orientation) will be 
considered the same target.  
 
Laser marking will then be performed.  A double laser mark will be applied to all 
IRIS ROIs. A single laser mark will be applied to VLE ROIs. Targeted biopsies 
will be taken of all laser marks and placed in separate biopsy jars.   Biopsies will be 
taken in between the laser marks for double laser marked areas. For single laser 
marks, biopsies will be taken on either side of the laser mark. Resection of visible 
lesions will then occur per standard of care (if present) followed by random 
biopsies of the segment. Random biopsies are pinch biopsies every 1 cm the length 
of the Barrett’s in a 4 quadrant fashion per gastrointestinal society guidelines. 
There are no additional research biopsies being performed outside this study. The 
targeted biopsies are based on the VLE features that are suspicious for dysplasia 
and thus standard of care. The other biopsies being performed here are random 
biopsies which are also being performed for standard of care. Biopsied samples 
will be stored per standard of care procedures per the pathology department.  They 
will not be stored for future research purposes.  
 
 
Following each procedure, the physician will be asked a series of Likert Scale 
questions (see post-protcol survey in case report form) to assess the utility of IRIS 
in that procedure, including how it impacts their confidence in image interpretation, 
their ability to assimilate data more easily and quickly, and their overall perception 
of the technology. 
 
Although, the VLE with IRIS and VLE without IRIS are being performed as 
standard of care, all adverse events will be recorded and reported to the IRB.  
 

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All data will be entered into a central encrypted REDCap database.   
 
Expert pathologists who specialize in gastrointestinal pathology will read the 
histology. A second gastrointestinal pathologist will confirm any histologic 
diagnosis of dysplasia. This is the standard of care at Northwell Health and 
academic medical centers per gastrointestinal society guidelines. 
 
All procedures (upper endoscopy, volumetric laser endomicroscopy, and IRIS 
enhanced VLE) will be performed as standard of care.  The prospective data 
collection and initial randomization will be the research component. All data 
collected will be de-identified before being transferred into a database. This will be 
kept in a safe place that is only accessible to the research team. 
. 
 
 
3. INTRODUCTION/BACKGROUND MATERIAL/PRELIMINARY STUDIES AND 
SIGNIFICANCE 
• Describe and provide the results of previous work by yourself or others, including 
animal studies, laboratory studies, pilot studies, pre-clinical and/or clinical studies 
involving the compound or device to be studied.  
• Include information as to why you are conducting the study and how the study differs 
from what has been previously researched, including what the knowledge gaps are. 
• Describe the importance of the knowledge expected to result 
 
Barrett’s esophagus (BE) is a change from normal esophageal squamous epithelium 
to specialized intestinal metaplasia.[1]  It is estimated that 5.6% of adults in the 
United States have BE.[2]   BE is a major risk factor for esophageal 
adenocarcinoma (EAC), the incidence of which continues to rise.[3] Interventions 
to impact the increasing incidence of EAC are limited due to two factors: 1) many 
patients with BE may remain undiagnosed until a symptomatic cancer arises;[4] 
and 2) traditional surveillance approaches are imperfect at identifying which BE 
patients will progress to cancer.[5]  
 
Currently, cancer risk stratification in BE is based upon the detection of dysplasia 
in random biopsies taken ever 1-2 cm over the length of the BE.[1,6]  However, 

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detecting and appropriately classifying dysplasia can be difficult.  Dysplasia may 
be focal, and most biopsy techniques sample a fraction of the BE.[7] Moreover, 
endoscopic surveillance of patients with known BE may not improve mortality 
from EAC,[5] though it is associated with increased cost.  Thus, current needs in 
the evaluation of BE include improvements in screening approaches and the ability 
to detect dysplasia.  
 
Volumetric laser endomicroscopy (VLE) procedures use an advanced imaging 
technology that became commercially available in the United States in 2013 
(NvisionVLE® imaging System, NinePoint Medical Inc., Bedford, MA). The VLE 
procedure uses an FDA-cleared second-generation optical coherence tomography 
(OCT) technology.  It uses infrared light to produce real time high-resolution cross 
sectional imaging of the esophagus. The NvisionVLE system can scan a 6 cm 
length of the esophagus in approximately 90 seconds, providing surface and 
subsurface wide-field cross-sectional imaging with an axial resolution of 7 μm, and 
to a depth of 3 mm.[8,9]  The VLE imaging system consists of a console, monitor, 
and optical probe contained within a Mylar balloon on an 8Fr, 260 cm catheter.  
The distal end of the catheter connects to the console. The probe is available in 14 
mm, 17 mm, and 20 mm diameter balloons that are 6 cm in length. The balloon is 
positioned such that the distal margin of the balloon is located 1 cm distal to the 
gastroesophageal junction.  This allows a single scan to image the gastric cardia, 
the gastro-esophageal (GE) junction, and the distal esophagus.  The balloon is 
inflated to 15 psi, though depending on anatomy the balloon inflation pressure may 
be modified accordingly.  The inflated balloon allows for centering and anchoring 
of the probe while helical scanning occurs. Imaging is performed during automatic 
retraction of the probe from the distal to proximal end of the balloon over a 90 
second period, creating real time 360-degree images.  Twelve hundred cross 
sectional scans are generated over the 6 cm segment.  VLE scans are viewed by 
using a software interface that allows real time viewing of cross-sectional, 
transverse, and longitudinal views.   There is a registration line on the balloon and 

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the VLE images that allows for orientation of VLE images with endoscopic 
imaging.  
 
A recent upgrade to the imaging platform includes the ability to perform superficial 
laser marking of the esophageal epithelium when suspicious areas are identified on 
VLE to provide more precise targeting for biopsies or endoscopic resection .[10] A 
safety and efficacy study was performed evaluating VLE with a prototype laser 
marking device in 16 BE patients with 222 laser marks placed.[11]  The study 
showed that laser marking was safe and efficacious with an 85% positional 
accuracy rate of the laser marks.    
 
Scoring systems for OCT and VLE images have been developed to help detect 
neoplasia (HGD and intramucosal cancer) in BE.[12,13]  These scoring systems 
were developed by VLE scanning ex vivo endoscopic resection specimens and 
correlating VLE features to histology.[14–16] A potential advantage of VLE is its 
ability to detect subepithelial disease in BE,[16–18] though the clinical relevance of 
these findings remains uncertain.[19] 
 
Multiple case reports and case series have demonstrated the potential of VLE to 
identify dysplasia in BE not detected by high-definition white light endoscopy or 
electronic chromoendoscopy.[14–16,20]  A large single center retrospective series 
found an incremental yield of dysplasia detection using VLE with laser marking 
compared to VLE without laser marking or random biopsies.[21] A study looked at 
the interobserver agreement between users at high-volume academic centers based 
on still images and found strong agreement for non-neoplastic and neoplastic BE 
(kappa 0.66 and 0.79).[22]   Although the learning curve for interpretation of VLE 
images appears to be favorable,[23] a large amount of complex data is interpreted 
by the endoscopist in real-time.  Thus, computer-aided analysis of VLE data could 
aid in image interpretation mid-procedure. [12, 13, 24] One academic group has 
developed computer algorithms to aid with the detection of BE neoplasia,  
evaluating a prototype computer-aided detection program using 60 VLE images of 

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Page 7 of 29 
ex vivo endoscopic resection specimens.[25] The study found that the computer-
aided detection was able to detect neoplasia with a 90% sensitivity and 93% 
specificity.  An artificial intelligence algorithm to segment and display commonly 
observed esophageal features [12, 13, 24] has been commercially developed, and is 
cleared by the FDA. This product is termed intelligent real-time image 
segmentation (IRIS).   The computer software highlights three VLE features that 
could be associated with dysplasia according to previous literature [12, 13, 24].  
The aim of this study is to evaluate the impact of IRIS for management of patients 
with Barrett’s Esophagus and Barrett’s related dysplasia with experts in VLE. 
 
Intelligent Real-time Image Segmentation (IRIS) 
The IRIS upgrade has the ability to identify and display three specific images 
features that may correlate with dysplasia. The three features are represented in 
different color schemes to help identify the features (FIGURE 1).  The three 
features of interest include a hyper-reflective surface, hypo-reflective structures, 
and a lack of layering. A hyper-reflective surface indicates a high surface signal 
relative to the subsurface and is calculated by signal drop off over depth. The 
image feature is represented by a pink color bar at the tissue surface. The pink 
intensity increases with greater signal drop-off between the surface and subsurface. 
Layering indicates a separation of a homogeneous, low-signal layer from a hyper-
reflective interface below. This image feature is represented by an orange color bar 
at the exterior edge of the VLE image space. The orange, when present, indicates 
lack of layering while black indicates strong layering. The last feature highlighted 
in IRIS is a hyo-reflective structure. These are closed low signal regions that stand 
out from surrounding tissue texture. The image feature is represented by a blue 
image overlay on top of the identified hypo-reflective structure.  
 
IRIS features are controlled from the physician screen on the VLE console or by 
the hand controller. 
 
 
 

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4. OBJECTIVE(S)/SPECIFIC AIMS AND HYPOTHESES 
• A concise statement of the goal(s) of the current study.  
• The rationale for and specific objectives of the study.  
• The goals and the hypothesis to be tested should be stated. 
 
1. To determine if IRIS facilitates interpretation of VLE images compared to VLE alone 
2. To determine if IRIS increases the diagnostic yield for dysplasia compared to VLE 
alone and random biopsies 
3. To determine if IRIS decreases the number of biopsies needed to identify dysplasia 
compared to VLE alone and random biopsies 
 
 
 
5.  RESOURCES AVAILABLE TO CONDUCT THE HUMAN RESEARCH 
• Explain the feasibility of meeting recruitment goals of this project and demonstrate a 
potential for recruiting the required number of suitable subjects within the agreed 
recruitment period 
o How many potential subjects do you have access to? 
• Describe your process to ensure that all persons assisting with the trial are 
adequately informed about the protocol and their trial related duties and functions 
 
Patients approached for participating in this study will be scheduled per standard of 
care procedures for their condition. The volume of patients who meet this criteria is 
more than sufficient to achieve the enrollment goal of 200 patients.   
 
 
 
6.  RECRUITMENT METHODS 
• Describe the source of potential subjects 
• Describe the methods that will be used to identify potential subjects 
• Describe any materials that will be used to recruit subjects.  A copy of any 
advertisements (flyers, radio scripts, etc.) should be submitted along with the 
protocol.  
• If monetary compensation is to be offered, this should be indicated in the protocol 
 
Patients 18 years of age and older with Barrett’s esophagus greater than 2cm in 
length and who are scheduled to undergo an upper endoscopy with VLE exam for 
surveillance as standard of care will be approached before their scheduled exam to 
obtain informed consent to participate in this study. No recruitment materials or 

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advertisements will be used in this study. Subjects will not receive monetary 
compensation for their participation.  
 
We are fortunate that the two participants of the trial (Dr Trindade and Dr 
McKinley) have high volume Barrett’s esophagus practices. Both physicians 
routinely perform VLE.  Thus patients who are undergoing VLE as standard of care 
will be asked if they wish to participate in the trial. 
. 
 
 
7.  ELIGIBILITY CRITERIA 
• Describe the characteristics of the subject population, including their anticipated 
number, age, ranges, sex, ethnic background, and health status. Identify the criteria 
for inclusion or exclusion of any subpopulation.  
• Explain the rationale for the involvement of special classes of subjects, such as 
fetuses, pregnant women, children, prisoners or other institutionalized individuals, or 
others who are likely to be vulnerable.   You cannot include these populations in your 
research, unless you indicate such in the protocol 
• Similarly, detail exclusionary criteria: age limits, special populations (minors, 
pregnant women, decisionally impaired), use of concomitant medications, subjects 
with other diseases, severity of illness, etc. 
 
Inclusion criteria:  
1. 18 years of age or older at the time of informed consent 
2. Barrett’s esophagus greater than 2 cm in length  
3. Undergoing a scheduled upper endoscopy with VLE exam for surveillance as 
standard of care 
 
Exclusion criteria: 
1. Less than 18 years old at the time of informed consent 
2. Unable to provide written informed consent  
3. Esophageal stenosis/stricture preventing VLE 
4. Esophagitis  
5. Severe medical comorbidities preventing endoscopy  
6. Pregnancy  
7. Uncontrolled coagulopathy 

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8.  NUMBER OF SUBJECTS 
• Indicate the total number of subjects to be accrued locally.  If applicable, distinguish 
between the number of subjects who are expected to be pre-screened, enrolled 
(consent obtained), randomized and complete the research procedures. 
• If your study includes different cohorts, include the total number of subjects in each 
cohort. 
• If this is multisite study, include total number of subjects across all sites.   
 
This is a multi-site randomized trial with an anticipated enrollment of 200 patients. 
We anticipate adding up to 3 other sites. Half of all patients should have a prior 
diagnosis of dysplasia to ensure a sample that has an adequate number of dysplastic 
patients. 
 
The primary outcome will be time to interpretation of a VLE scan with and without 
IRIS.  Dysplasia detected in each arm and number of biopsies  are secondary 
outcomes and not expected to be that much different as expert VLE users will be 
involved in the study.  The expected mean time for a VLE without IRIS is 5 min 
+/- 3 min. The mean time for a VLE without IRIS (standard) is 3 min. With a CI of 
95% and power of 90%, the sample size for 1:1 randomization is 94 (47 in each 
group). Our sample size is 200 to allow for screen failures.  
 
 
  
 
 
9. STUDY TIMELINES 
• Describe the duration of an individuals participation in the study 
• Describe the duration anticipated to enroll all study subjects 
• The estimated date of study completion 
 
Subjects enrolled in this study will participate on the day of their scheduled upper 
endoscopic procedure, which will last for about 1 hour. Subsequently, these 
patients will be followed for a period of about 1 year via their electronic medical 

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records. After the day of the initial procedure, they will not be contacted for study 
related purposes. 
 
 
 
10.  ENDPOINTS 
• Describe the primary and secondary study endpoints 
• Describe any primary or secondary safety endpoints  
 
The following outcomes will be measured: 
     - Primary Outcome: The time for image interpretation in each arm will be 
compared. Time will be a surrogate for ease of interpretation. Time will be 
recorded from start of image interpretation to the end of image interpretation.  
Length of Barrett’s will be taken into account (time per cm of Barrett’s) when 
comparing this outcome between patients and procedures. 
     - Secondary Outcome: Biopsy yield of dysplasia/diagnosis of dysplasia 
(dysplasia present versus not) of IRIS biopsies (double laser mark) will be 
compared to VLE without IRIS biopsies (single laser mark) and random biopsies. 
     - Secondary Outcome: The number of biopsies will be compared among all 
groups. 
 
 
 
11.  RESEARCH PROCEDURES 
• Include a detailed description of all procedures to be performed on the research 
subject and the schedule for each procedure. 
• Include any screening procedures for eligibility and/or baseline diagnostic tests 
• Include procedures being performed to monitor subjects for safety or minimize risks 
• Include information about drug washout periods 
• If drugs or biologics are being administered provide information on dosing and route 
of administration 
• Clearly indicate which procedures are only being conducted for research purposes. 
• If any specimens will be used for this research, explain whether they are being 
collected specifically for research purposes.   
• Describe any source records that will be used to collect data about subjects 
• Indicate the data to be collected, including long term follow-up 
 

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This is a prospective randomized clinical trial examining how IRIS (Intelligent 
Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric laser 
endomicroscopy). Patients will undergo a VLE exam with and without IRIS per the 
standard of care.  All patients regardless of the study participation in this study 
would receive VLE with and without IRIS clinically. Thus randomization into a 
particular order will not require more procedure time. They will be randomized into 
VLE without IRIS first vs VLE with IRIS first.  Subjects will be randomized with 
the BUDDY Randomization System provided for use by the Northwell Health 
Biostatistics Unit. Randomization will occur before the procedure starts. 
Randomization will be stratified based on prior diagnosis of dysplasia.  The order 
the patient is randomized to will be recorded on the case report form. There will be 
concealed allocation as the study coordinator performing the randomization will 
not know the order of the next allocation.  
 
Both VLE and IRIS imaging are being performed as standard of care.  However, 
randomization of the order allows for comparison of the two.  Regions of interest 
(ROI) will be recorded using a full scan and recorded on the case report form.  The 
time to identification of ROIs will also be recorded (from start of image 
interpretation to the end).  Each group will then cross over such that the VLE 
without IRIS group will then have IRIS turned on ROI will then be recorded for 
each group based on full scans.  A consensus ROI will be recorded based on the 
two exams.  Only one ROI per centimeter will be allowed to avoid overlapping of 
laser marks.  In addition VLE without IRIS and IRIS marks within 75 frames of 
each other or 2 hours (on a clock face orientation) will be considered the same 
target.  
 
Laser marking will then be performed.  A double laser mark will be applied to all 
IRIS ROIs. A single laser mark will be applied to VLE ROIs. Targeted biopsies 
will be taken of all laser marks and placed in separate biopsy jars.   Biopsies will be 
taken in between the laser marks for double laser marked areas. For single laser 
marks, biopsies will be taken on either side of the laser mark. Resection of visible 

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Page 13 of 29 
lesions will then occur per standard of care (if present) followed by random 
biopsies of the segment. Random biopsies are pinch biopsies every 1 cm the length 
of the Barrett’s in a 4 quadrant fashion per gastrointestinal society guidelines.This 
is all per standard of care.  There are no additional research biopsies being 
performed outside this study. The targeted biopsies are based on the VLE features 
that are suspicious for dysplasia and thus standard of care. The other biopsies being 
performed here are random biopsies which are also being performed for standard of 
care.  Biopsied samples will be stored per standard of care procedures per the 
pathology department.  They will not be stored for future research purposes.  
 
Following each procedure, the physician will be asked a series of Likert Scale 
questions to assess the utility of IRIS in that procedure, including how it impacts 
their confidence in image interpretation, their ability to assimilate data more easily 
and quickly, and their overall perception of the technology. 
 
Although the VLE with IRIS and VLE without IRIS are being performed as 
standard of care, all adverse events will be recorded and reported to the IRB.  
 
All data will be entered into a central encrypted REDCap database housed within 
the Northwell server.   
 
Expert pathologists who specialize in gastrointestinal pathology will read the 
histology. A second gastrointestinal pathologist will confirm any histologic 
diagnosis of dysplasia. This is the standard of care at Northwell Health and 
academic medical centers per gastrointestinal society guidelines. 
 
All procedures (upper endoscopy, volumetric laser endomicroscopy, and IRIS 
enhanced VLE) will be performed as standard of care.  The prospective data 
collection and initial randomization of order of use of IRIS will be the research 
component. All data collected will be de-identified before being transferred into a 

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Page 14 of 29 
database. This will be kept in a safe place that is only accessible to the research 
team. 
 
 
 
12.  STATISTICAL ANALYSIS 
• Describe how your data will be used to test the hypotheses.  
• State clearly what variables will be tested and what statistical tests will be used. 
• Include sample size calculations.  
• If this is a pilot study, state which variables will be examined for hypothesis 
generation in later studies.  
 
The categorical variables will be compared using Fisher exact tests (eg: presence of 
dysplasia). Continuous variables between the two groups will be analyzed using the 
student t-test. All statistical tests will be 2-sided, and P < .05 will considered 
significant. All statistics will be run using SAS version 9.4 (SAS Institute Inc, 
Cary, NC, USA). 
 
Time to interpretation is likely normally distributed.  For outcomes like  
number of biopsies, if post study analysis shows this is not normally distributed, we 
can use median values instead of means or perform a log correction.  
 
 
 
 
13. SPECIMEN BANKING 
• If specimens will be banked for future research, describe where the specimens will be 
stored, how long they will be stored, how they will be accessed and who will have 
access to the specimens 
• List the information that will be stored with each specimen, including how specimens 
are labeled/coded 
• Describe the procedures to release the specimens, including:  the process to request 
release, approvals required for release, who can obtain the specimens, and the 
information to be provided with the specimens. 
 
N/A 
 
 
14.  DATA MANAGEMENT AND CONFIDENTIALITY 
• Describe the data and specimens to be sent out or received.  As applicable, describe: 

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o What information will be included in that data or associated with the 
specimens? 
o Where and how data and specimens will be stored? 
o How long the data will be stored? 
o Who will have access to the data? 
o Who is responsible for receipt or transmission of data and specimens? 
• Describe the steps that will be taken to secure the data during storage, use and 
transmission. 
 
Data being collected for this study will adhere to the institutional policies related to 
research. Data related to the procedure and device will be recorded, including date 
of procedure, indication for procedure, concurrent medications. Medical history 
will also be recorded, including previous histopathological diagnoses, previous 
medications, and previous therapy for Barrett’s esophagus. The data will be stored 
on Northwell’s REDCap server. 
 
 
 
15.  DATA AND SAFETY MONITORING PLAN 
 
A specific data and safety monitoring plan is only required for greater than minimal risk 
research.  For guidance on creating this plan, please see the Guidance Document on the 
HRPP website. 
 
Part I – this part should be completed for all studies that require a DSMP.   
Part II – This part should be completed when your study needs a Data and 
Safety Monitoring Board or Committee (DSMB/C) as part of your Data and 
Safety Monitoring Plan.   
 
Part I:  Elements of the Data and Safety Monitoring Plan 
•  Indicate who will perform the data and safety monitoring for this study.   
• Justify your choice of monitor, in terms of assessed risk to the research subject’s 
health and well being.  In studies where the monitor is independent of the study staff, 
indicate the individual’s credentials, relationship to the PI, and rationale for selection 
• List the specific items that will be monitored for safety (e.g. adverse events, protocol 
compliance, etc) 
• Indicate the frequency at which accumulated safety and data information (items listed 
in # above) will be reviewed by the monitor (s) or the DSMB/C.   
• Where applicable, describe rules which will guide interruption or alteration of the 
study design.   
• Where applicable, indicate dose selection procedures that will be used to minimize 
toxicity. 
• Should a temporary or permanent suspension of your study occur, in addition to the 
IRB, indicate to whom will you report the occurrence.   
 

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Data will be closely monitored by the PI. This monitoring will be done on an 
ongoing basis and will focus on any adverse events or unanticipated problems 
which will be reported immediately to the PI. These will be analyzed for 
relatedness, although no relatedness to research is anticipated since this is data 
collection only. Protocol compliance will be monitored via data entry in REDCap 
and by verification of source documentation when required. 
 
 
 
Part II:  Data and Safety Monitoring Board or Committee 
 
 
•  When appropriate, attach a description of the DSMB.   
• Provide the number of members and area of professional expertise.   
• Provide confirmation that the members of the board are all independent of the study. 
 
N/A 
 
 
16. WITHDRAWAL OF SUBJECTS 
• Describe anticipated circumstances under which subjects will be withdrawn from the 
research without their consent 
• Describe procedures for orderly termination 
• Describe procedures that will be followed when subjects withdraw from the research, 
including partial withdrawal from procedures with continued data collection.   
 
If the subject consents to the study and meets all criteria at the time of the initial 
procedure, they will be considered enrolled unless the patient provides written 
documentation of their decision to withdraw from the study.  
 
 
 
17. RISKS TO SUBJECTS 
• Describe any potential risks and discomforts to the subject (physical, psychological, 
social, legal, or other) and assess their likelihood and seriousness and whether side 
effects are reversible. Where appropriate, describe alternative treatments and 
procedures that might be advantageous to the subjects.  
• Include risks to others , like sexual partners (if appropriate) 
• Discuss why the risks to subjects are reasonable in relation to the anticipated benefits 
and in relation to the importance of the knowledge that may reasonably be expected 
to results 

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• Describe the procedures for protecting against or minimizing any potential risks, 
including risks to confidentiality, and assess their likely effectiveness.   
 
There are no additional risks or discomforts anticipated for the patient if he or she 
decides to participate in this research. Subjects’ alternatives are to not participate in 
the research study.  
 
 
 
 
18. RESEARCH RELATED HARM/INJURY 
• Describe the availability of medical or psychological resources that subjects might 
need as a result of anticipated problems that may be known to be associated with the 
research. 
• If the research is greater than minimal risk, explain any medical treatments that are 
available if research-related injury occurs, who will provide it, what will be provided, 
and who will pay for it.   
 
Subjects will be undergoing VLE with and without computer enhancement as part 
of their standard of care. They are aware of and consent to this procedure and 
associate risks separately from this research study. The research component will 
involve recording information during the exam.  It is not anticipated that this causes 
any additional risk. De-identified data will be recorded in an encrypted database.  
While there is always a potential for breach of information, every effort is in place 
to ensure this security. 
 
 
 
19. POTENTIAL BENEFIT TO SUBJECTS 
 
• Explain what benefits might be derived from participation in the study, noting in 
particular the benefit over standard treatment (e.g. a once-a-day administration 
instead of four times a day, an oral formulation over an IV administration).  
• Also state if there are no known benefits to subjects, but detail the value of knowledge 
to be gained 
 
While this research will likely not provide subjects’ any direct benefit, it will 
potentially benefit patients with the same disease in the future. 
 
 

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20. PROVISIONS TO PROTECT PRIVACY INTERESTS OF SUBJECTS 
 
• Describe the methods used to identify potential research subjects, obtain consent and 
gather information about subjects to ensure that their privacy is not invaded.  
• In addition consider privacy protections that may be needed due to communications 
with subjects (such as phone messages or mail).   
 
Research related documents used to record information for this study, such as data 
stored on paper (informed consent forms, case report forms, procedure reports, 
pathology reports) will be stored in locked cabinets which are only accessible to 
those approved to participate in this study. Electronic information will be kept 
within the HIPAA compliant database, REDCap. Any email correspondence with 
potentially-identifying information will be encrypted. 
 
 
 
 
21.  COSTS TO SUBJECTS 
 
• Describe any foreseeable costs that subjects may incur through participation in the 
research 
• Indicate whether research procedures will be billed to insurance or paid for by the 
research study.   
 
There are no additional costs to subjects if they choose to participate in this study. 
 
 
 
22. PAYMENT TO SUBJECTS  
 
• Describe the amount of payment to subjects, in what form payment will be received 
and the timing of the payments.   
 
Subjects will not be paid for participating in this study. 
 
 
23.  CONSENT PROCESS 
 
If obtaining consent for this study, describe: 
• Who will be obtaining consent 
• Where consent will be obtained 
• Any waiting period available between informing the prospective participant and 
obtaining consent 

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• Steps that will be taken to assure the participants’ understanding 
• Any tools that will be utilized during the consent process 
•   Information about how the consent will be documented in writing.  If using a  
standard consent form, indicate such.   
• Procedures for maintaining informed consent.   
 
Consent for this study will only be obtained by those approved to do so. At the 
time of consent, the investigator will explain in detail the data that will be 
collected as part of this study. It will be explained to subjects why they are 
eligible to participate. Before signing the consent form, patients will be asked if 
they understand what their participation involves. Original copies of the 
consent forms will be stored in a study binder accessible to the research staff. 
Subjects will be given a copy of the signed consent form for their records. The 
subject, investigator, and a witness will print and sign their names and the date 
the informed consent process takes place. Enrollment notes will be written to 
outline the process and these will be signed by the investigator. 
 
 
 
In the state of NY, any participants under the age of 18 are considered children.  If your 
study involves children, additional information should be provided to describe: 
• How parental permission will be obtained 
• From how many parents will parental permission be obtained 
• Whether permission will be obtained from individuals other than parents, and if 
so, who will be allowed to provide permission.  The process used to determine 
these individual’s authority to consent for the child should be provided 
• Whether or not assent will be obtained from the child 
• How will assent be documented 
• Whether child subjects may be expected to attain legal age to consent to the 
procedures for research prior to the completion of their participation in the 
research.  If so, describe the process that will be used to obtain their legal 
consent to continue participation in the study.  Indicate what will occur if consent 
is not obtained from the now-adult subjects.   
 
N/A 
 
 
If the study involves cognitively impaired adults, additional information should be 
provided to describe: 
• The process to determine whether an individual is capable of consent 
• Indicate who will make this assessment 

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• The plan should indicate that documentation of the determination  and 
assessment will be placed in the medical record, when applicable, in addition to 
the research record. 
• If permission of a legally authorized representative will be obtained, 
o  list the individuals from who permission will be obtained in order of priority 
o Describe the process for assent of subjects; indicate whether assent will be 
required of all, some or none of the subjects.  If some, which subjects will be 
required to assent and which will not. 
o If assent will not be obtained from some or all subjects, provide an 
explanation as to why not 
o Describe whether assent will be documented and the process to document 
assent 
o Indicate if the subject could regain capacity and at what point you would 
obtain their consent for continued participation in the study 
 
N/A 
 
 
If the study will enroll non-English speaking subjects: 
• Indicate what language(s) other than English are understood by prospective 
subjects or representatives 
• Indicate whether or not consent forms will be translated into a language other 
than English 
• Describe the process to ensure that the oral and written information provided 
to those subjects will be in that language 
• If non-English speaking subjects will be excluded, provide a justification for 
doing so 
 
N/A 
 
 
24.  WAIVER OR ALTERATION OF THE CONSENT PROCESS       
 N/A          
 
Complete this section if you are seeking an alteration or complete waiver of the consent   
process. 
• Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk to the subject:   
• Explain why the waiver/ alteration will not adversely affect the rights and welfare 
of subjects 
• Explain why it is impracticable to conduct this research if informed consent is 
required   
• Explain why it is not possible to conduct this research without using the 
information or biospecimens in an identifiable form 
• If appropriate, explain how the subjects will be provided with additional pertinent 
information after participation.   If not appropriate to do so, explain why.  
 

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N/A 
 
Complete this section if you are obtaining informed consent but you are requesting a 
waiver of the documentation of consent (i.e., verbal consent will be obtained). To 
proceed with a waiver based on these criteria, each subject must be asked whether they 
wish to have documentation linking them to this study.  Only complete subsection 1 OR 
subsection 2.  
 
  SUBSECTION 1 
 
• Explain how the only record linking the subject to the research would be the 
consent document. 
• Explain how the principal risk of this study would be the potential harm resulting 
from a breach in the confidentiality 
• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
N/A 
 
SUBSECTION 2 
•  Describe the possible risks of harm to the subjects involved in this study and 
explain why the study involves no more than minimal risk.   
• Confirm that the research only involves procedure for which consent is not 
normally required outside the research context.  
• Indicate whether or not subjects will be provided with a written statement 
regarding the research. 
 
N/A 
 
. 
 
25. WAIVER OF HIPAA AUTHORIZATION  
 
 
 
 N/A       
 
Complete this section if you seek to obtain a full waiver of HIPAA authorization to use 
and/or disclose protected health information.  
• Describe the risks to privacy involved in this study and explain why the study 
involves no more than minimal risk to privacy:   
• Describe your plan to protect identifiers from improper use or disclosure and to 
destroy them at the earliest time. 
•  Indicate why it is not possible to seek subjects’ authorization for use or 
disclosure of PHI. 
• Indicate why it is not possible to conduct this research without use or disclosure 
of the PHI.   
• Indicate if PHI will be disclosed outside NSLIJ Health System, and if so, to whom.   
Note:  PHI disclosed outside NSLIJ Health System, without HIPAA authorization 
needs to be tracked. Please see guidance at www.nslij.com/irb for information 
about tracking disclosures. 

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Page 22 of 29 
 
N/A 
 
Complete this section if you seek to obtain a partial waiver of the patient’s 
authorization for screening/recruitment purposes (i.e., the researcher does not have 
access to patient records as s/he is not part of the covered entity) 
Note: Information collected through a partial waiver for recruitment cannot be shared 
or disclosed to any other person or entity. 
• Describe how data will be collected and used:  
• Indicate why you need the PHI (e.g.PHI is required to determine eligibility, 
identifiers are necessary to contact the individual to discuss participation, other) 
• Indicate why  the research cannot practicably be conducted without the partial 
waiver (e.g. no access to medical records or contact information of the targeted 
population, no treating clinician to assist in recruitment of the study population, 
other) 
A partial waiver of HIPAA authorization would be required for this study to 
ensure a patient’s medical history (i.e. pathological diagnosis of Barrett’s 
esophagus and endoscopic length of disease, medical comorbidities, other 
exclusionary criteria) meets inclusion criteria prior to approaching the patient 
for written informed consent. These elements would be recorded as part of the 
research if the patient does consent to participate. If the patient does not meet 
the criteria during pre-screening, the data elements would not be collected or 
stored.  
 
 
 
26.  VULNERABLE POPULATIONS: 
 
Indicate whether you will include any of these vulnerable populations. If indicated, 
submit the appropriate appendix to the IRB for review: 
 
  Children or viable neonate 
  Cognitively impaired 
  Pregnant Women, Fetuses or neonates of uncertain viability or nonviable  
  Prisoners 
  NSLIJ Employees, residents, fellows, etc 
  poor/uninsured 
  Students 
  Minorities 
  Elderly 
  Healthy Controls 

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If any of these populations are included in the study, describe additional safeguards that 
will be used to protect their rights and welfare. 
 
N/A 
 
 
27.  MULTI-SITE HUMAN RESEARCH (COORDINATING CENTER) 
 
If this is a multi-site study where you are the lead investigator, describe the management 
of information (e.g. results, new information, unanticipated problems involving risks to 
subjects or others, or protocol modifications) among sites to protect subjects. 
Information related to the study will be promptly disseminated to participating sites. 
This information will include any interim analysis, adverse events, or protocol 
modifications. Confirmation of receipt of important documents will be requested. 
Copies of each site’s IRB approvals will be kept at the main site to ensure that all sites 
are adequately approved. Representatives from the research teams will be given access 
to the REDCap project, where they will be able to enter data only into their respective 
Data Access Groups. Access to the BUDDY Randomization System will be allocated 
to each site, where the lead PI will be copied on all correspondence related to 
randomization allocations and enrollment updates. 
 
 
 
 
 
28.  REFERENCES/BIBIOGRAPHY 
 
Provide a reasonable list of references directly related to the study. Any diagrams for 
new medical devices or brief reprints from journals might also prove useful. 
 
1 
Shaheen NJ, Falk GW, Iyer PG, Gerson LB, American College of 
Gastroenterology. ACG Clinical Guideline: Diagnosis and Management of 
Barrett’s Esophagus. Am J Gastroenterol 2016; 111: 30–50; quiz 51 Im Internet: 
http://dx.doi.org/10.1038/ajg.2013.196 
2 
Spechler SJ, Souza RF. Barrett’s Esophagus. N Engl J Med 2014; 371: 836–845 
Im Internet: http://www.nejm.org/doi/abs/10.1056/NEJMra1314704 
3 
Pohl H, Welch HG. The role of overdiagnosis and reclassification in the marked 

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increase of esophageal adenocarcinoma incidence. J Natl Cancer Inst 2005; 97: 
142–146 
4 
Bhat SK, McManus DT, Coleman HG, Johnston BT, Cardwell CR, McMenamin 
Ú, Bannon F, Hicks B, Kennedy G, Gavin AT, Murray LJ. Oesophageal 
adenocarcinoma and prior diagnosis of Barrett’s oesophagus: a population-based 
study. Gut 2015; 64: 20–25 Im Internet: 
http://gut.bmj.com/lookup/doi/10.1136/gutjnl-2013-305506 
5 
Corley DA, Mehtani K, Quesenberry C, Zhao W, de Boer J, Weiss NS. Impact 
of endoscopic surveillance on mortality from Barrett’s esophagus-associated 
esophageal adenocarcinomas. Gastroenterology 2013; 145: 312–9.e1 Im 
Internet: http://www.ncbi.nlm.nih.gov/pubmed/23673354 
6 
Levine DS, Haggitt RC, Blount PL, Rabinovitch PS, Rusch VW, Reid BJ. An 
endoscopic biopsy protocol can differentiate high-grade dysplasia from early 
adenocarcinoma in Barrett’s esophagus. Gastroenterology 1993; 105: 40–50 Im 
Internet: http://www.ncbi.nlm.nih.gov/pubmed/8514061 
7 
Jankowski M, Wani S. Diagnostic and Management Implications of Basic 
Science Advances in Barrett’s Esophagus. Curr Treat Options Gastroenterol 
2015; 13: 16–29 Im Internet: http://link.springer.com/10.1007/s11938-014-
0040-9 
8 
Trindade AJ, Smith MS, Pleskow DK. The new kid on the block for advanced 
imaging in Barrett’s esophagus: a review of volumetric laser endomicroscopy. 
Therap Adv Gastroenterol 2016; 9: 408–416 Im Internet: 
http://tag.sagepub.com/cgi/doi/10.1177/1756283X16639003 
9 
Wolfsen HC, Sharma P, Wallace MB, Leggett C, Tearney G, Wang KK. Safety 
and feasibility of volumetric laser endomicroscopy in patients with Barrett’s 
esophagus (with videos). Gastrointest Endosc 2015; 82: 631–640 Im Internet: 
http://linkinghub.elsevier.com/retrieve/pii/S0016510715022786 
10 
Trindade AJ, Leggett CL, Chang KJ. Volumetric laser endomicroscopy in the 
management of Barrett’s esophagus. Curr Opin Gastroenterol 2017; Im Internet: 
http://www.ncbi.nlm.nih.gov/pubmed/28402993 
11 
Swager A, de Groof AJ, Meijer SL, Weusten BL, Curvers WL, Bergman JJ. 

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Feasibility of laser marking in Barrett’s esophagus with Volumetric laser 
endomicroscopy First-in-man pilot study. Gastrointest Endosc 2017; Im 
Internet: http://www.ncbi.nlm.nih.gov/pubmed/28161451 
12 
Swager A-F, Tearney GJ, Leggett CL, van Oijen MGH, Meijer SL, Weusten 
BL, Curvers WL, Bergman JJGHM. Identification of volumetric laser 
endomicroscopy features predictive for early neoplasia in Barrett’s esophagus 
using high-quality histological correlation. Gastrointest Endosc 2016; Im 
Internet: http://dx.doi.org/10.1016/j.gie.2016.09.012 
13 
Leggett CL, Gorospe EC, Chan DK, Muppa P, Owens V, Smyrk TC, Anderson 
M, Lutzke LS, Tearney G, Wang KK. Comparative diagnostic performance of 
volumetric laser endomicroscopy and confocal laser endomicroscopy in the 
detection of dysplasia associated with Barrett’s esophagus. Gastrointest Endosc 
2015; Im Internet: 
http://linkinghub.elsevier.com/retrieve/pii/S0016510715028229 
14 
Trindade AJ, Vamadevan AS, Sejpal D V. Finding a needle in a haystack: use of 
volumetric laser endomicroscopy in targeting focal dysplasia in long-segment 
Barrett’s esophagus. Gastrointest Endosc 2015; 82: 756–757 Im Internet: 
http://www.ncbi.nlm.nih.gov/pubmed/26005011 
15 
Trindade AJ, George BJ, Berkowitz J, Sejpal D V, McKinley MJ. Volumetric 
laser endomicroscopy can target neoplasia not detected by conventional 
endoscopic measures in long segment Barrett’s esophagus. Endosc Int open 
2016; 4: E318-22 Im Internet: http://www.ncbi.nlm.nih.gov/pubmed/27004250 
16 
Leggett CL, Gorospe E, Owens VL, Anderson M, Lutzke L, Wang KK. 
Volumetric laser endomicroscopy detects subsquamous Barrett’s 
adenocarcinoma. Am J Gastroenterol 2014; 109: 298–299 Im Internet: 
http://www.nature.com/ajg/journal/v109/n2/pdf/ajg2013422a.pdf 
17 
Swager A-F, Boerwinkel DF, de Bruin DM, Faber DJ, van Leeuwen TG, 
Weusten BL, Meijer SL, Bergman JJ, Curvers WL. Detection of buried Barrett’s 
glands after radiofrequency ablation with volumetric laser endomicroscopy. 
Gastrointest Endosc 2015; 1–9 Im Internet: 
http://linkinghub.elsevier.com/retrieve/pii/S0016510715024827 

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18 
Trindade AJ, Sideridis K, Thomas RM. Buried Barrett’s Esophagus Presenting 
as a Subepithelial Nodule. Am J Gastroenterol 2016; 111: 1378 Im Internet: 
http://www.ncbi.nlm.nih.gov/pubmed/27694877 
19 
Mashimo H. Subsquamous intestinal metaplasia after ablation of Barrett’s 
esophagus: frequency and importance. Curr Opin Gastroenterol 2013; 29: 454–
459 Im Internet: http://www.ncbi.nlm.nih.gov/pubmed/23674187 
20 
Atkinson C, Singh S, Fisichella PM. Volumetric laser endomicroscopy in the 
detection of neoplastic lesions of the esophagus. Dig Liver Dis 2016; 48: 692 Im 
Internet: http://www.ncbi.nlm.nih.gov/pubmed/26976783 
21 
Alshelleh M, Inamdar S, McKinley M, Stewart M, Novak JS, Greenberg RE, 
Sultan K, Devito B, Cheung M, Cerulli MA, Miller LS, Sejpal D V., Vegesna 
AK, Trindade AJ. Incremental yield of dysplasia detection in Barrett’s 
esophagus using volumetric laser endomicroscopy with and without laser 
marking compared with a standardized random biopsy protocol. Gastrointest 
Endosc 2018; Im Internet: 
http://linkinghub.elsevier.com/retrieve/pii/S0016510718300956 
22 
Trindade AJ, Inamdar S, Smith MS, Chang KJ, Leggett CL, Lightdale CJ, 
Pleskow DK, Sejpal D V, Tearney GJ, Thomas RM, Wallace MB. Volumetric 
laser endomicroscopy in Barrett’s esophagus: interobserver agreement for 
interpretation of Barrett’s esophagus and associated neoplasia among high-
frequency users. Gastrointest Endosc 2017; 86: 133–139 Im Internet: 
http://www.ncbi.nlm.nih.gov/pubmed/27899321 
23 
Trindade AJ, Inamdar S, Smith MS, Rosen L, Han D, Chang KJ, Leggett CL, 
Lightdale CJ, Pleskow DK, Sejpal D V, Tearney GJ, Thomas RM, Wallace MB. 
Learning curve and competence for volumetric laser endomicroscopy in 
Barrett’s esophagus using cumulative sum analysis. Endoscopy 2017; Im 
Internet: http://www.ncbi.nlm.nih.gov/pubmed/29179229 
24 
Evans J a., Poneros JM, Bouma BE, Bressner J, Halpern EF, Shishkov M, 
Lauwers GY, Mino-Kenudson M, Nishioka NS, Tearney GJ. Optical coherence 
tomography to identify intramucosal carcinoma and high-grade dysplasia in 
Barrett’s esophagus. Clin Gastroenterol Hepatol 2006; 4: 38–43 

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25 
Swager A-F, van der Sommen F, Klomp SR, Zinger S, Meijer SL, Schoon EJ, 
Bergman JJGHM, de With PH, Curvers WL. Computer-aided detection of early 
Barrett’s neoplasia using volumetric laser endomicroscopy. Gastrointest Endosc 
2017; Im Internet: http://www.ncbi.nlm.nih.gov/pubmed/28322771 
26 
Alvarez Herrero L, Curvers WL, van Vilsteren FGI, Wolfsen H, Ragunath K, 
Wong Kee Song L-M, Mallant-Hent RC, van Oijen A, Scholten P, Schoon EJ, 
Schenk EBE, Weusten BLAM, Bergman JGHM. Validation of the Prague C&M 
classification of Barrett’s esophagus in clinical practice. Endoscopy 2013; 45: 
876–882 Im Internet: http://www.ncbi.nlm.nih.gov/pubmed/24165812 
27 
The Paris endoscopic classification of superficial neoplastic lesions: esophagus, 
stomach, and colon: November 30 to December 1, 2002. Gastrointest Endosc 
2003; 58: S3-43 Im Internet: http://www.ncbi.nlm.nih.gov/pubmed/14652541 
 
List of Figures 

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FIGURE 1: A VLE image showing the three color schemes representing different 
features that could represent dysplasia. 
 
  
FIGURE 2: The flow diagram of study procedures. 

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