Global Prospective Case Series Using a Single-Use Duodenoscope
Phase: NA
Conditions: Endoscopic Retrograde Cholangiopancreatography
Sponsor: Boston Scientific Corporation

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Global Prospective Case Series using a Single-Use Duodenoscope 
Exalt DScope 02 
 
E7156 
CLINICAL INVESTIGATION PLAN 
 
National Clinical Trial (NCT) Identified Number: NCT04103749 
 
 
Sponsored By 
Boston Scientific Corporation 
300 Boston Scientific Way 
Marlborough, MA 01752-1234 
USA 
 
 
Boston Scientific International S.A. 
Parc Val Saint-Quentin, Bâtiment H 
2 Rue René Caudron 
78960 Voisins le Bretonneux 
France 
 
 
 
 
 
 
 
 
This protocol contains confidential information for use by the Investigators and their 
designated representatives participating in this clinical investigation. The protocol should be 
held confidential and maintained in a secure location. 
Do not copy or distribute without written permission from Boston Scientific Corporation. 
 
 
 

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Contact Information 
Role 
Contact  
Clinical Contact 
Gregory Tirrell 
Clinical Project Manager 
Clinical Endoscopy 
Boston Scientific Corporation 
200 Boston Scientific Way 
Marlborough, MA 01752-1234 USA 
Phone: 508.683.4260 
E-mail: gregory.tirrell@bsci.com 
 
Victoria Lazzari 
Associate Project Manager 
Clinical Endoscopy 
200 Boston Scientific Way 
Marlborough, MA 01752 
Phone: 508-382-9132 
E-mail: victoria.lazzari@bsci.com 
 
Pooja Goswamy 
Associate Director, Clinical Programs 
Clinical Endoscopy 
Boston Scientific Corporation 
200 Boston Scientific Way 
Marlborough, MA 01752-1234 USA 
Phone: 508-683-4335 
E-mail: pooja.goswamy@bsci.com 
Coordinating Principal 
Investigator(s) 
Marco Bruno, MD, PhD 
Head of Department of Gastroenterology & Hepatology 
Professor of Department of Gastroenterology & Hepatology 
Erasmus Medical Center 
‘s-Gravendijkwal 230 
3015 CE Rotterdam, Netherlands 
Phone: ++31-(0)10-4639222 
Fax: ++31-(0)10-4634682 
Email: m.bruno@erasmusmc.nl 
 
Adam Slivka, MD 
Director, GI Service Line, University of Pittsburgh Medical 
Center Health System 
Professor of Medicine, University of Pittsburgh School of 
Medicine 
University of Pittsburgh Medical Center Division of 
Gastroenterology, Hepatology and Nutrition 

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200 Lothrop Street 
Pittsburgh, PA 15213 USA 
Phone: 412.647.8132 
Fax: 412.864.5417 
Email: slivkaa@upmc.edu  
 

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Original Release: June 27, 2019 
Current Version: January 14, 2022 
 
 
 
 
Revision Version 
Protocol Date 
Template 
Number and 
Version 
Protocol 
Section 
Modified 
Summary of Changes 
 
Justification for Modification 
B 
August 14, 2019 
AL 
Contact 
Information, 
Protocol 
Synopsis,  
Section 1.2, 
Section 4 
The list of Coordinating Principal 
Investigators was reduced from 7 to 2 
The planned number of subjects was 
increased from 500 to 1000 
Additional information was added to 
the study rationale 
Minor additional changes throughout 
Per Investigator feedback 
C 
June 16, 2020 
92120219, 
Rev/Ver C 
Protocol 
Synopsis,  
Section 1.2 
Study 
Rationale, 
Table 5.3-1, 
Section 14.1 
Potential 
Risks and 
Benefits, 
Section 16.4 
Investigator 
Reporting 
Requirements 
Protocol Synopsis updated to change 
maximum number of sites from 20 to 
40, and Altered Pancreaticobiliary 
Anatomy exclusion criterion removed 
Section 1.2 updated to reflect the 
commercial availability of EXALT 
Table 5.3-1 updated to remove 
Altered Pancreaticobiliary Anatomy 
exclusion criterion 
Section 14.1 updated to refer to 
product DFU 
Section 16.4 updated to reflect post-
market reporting timelines 
Various minor terminology updates 
throughout 
Per Investigator feedback the Altered 
Pancreaticobiliary Anatomy 
exclusion criterion was removed. 
Because Exalt is commercially 
available it can be used in patients 
with altered pancreaticobiliary 
anatomy outside of this study, and 
this is not listed as a contraindication 
in the DFU. The intent of this study 
is to evaluate the performance of 
Exalt Model D in ERCPs and other 
duodenoscope-based procedures.  
“Altered pancreaticobiliary anatomy” 
is not a contraindication for the use 
of Exalt in the approved DFU.  This 
exclusion criterion was originally 
included due to questions of how 
well Exalt would be able to navigate 
tortuous GI anatomy based on 
insertion shaft stiffness, however 

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Revision Version 
Protocol Date 
Template 
Number and 
Version 
Protocol 
Section 
Modified 
Summary of Changes 
 
Justification for Modification 
these concerns have been resolved by 
the clinical experience to date. 
 
Update to Clinical Study Protocol 
Template (Post-Market) 92120219 
after FDA 510(k) clearance of the 
study device 
D 
January 14, 2022 
92120219, 
Rev/Ver G 
Cover Page; 
Section 3 
Study 
Objectives 
and 
Endpoints; 
Section 9.1 
Data 
Collection, 
Processing, 
and Review; 
Section 16 
Safety 
Reporting  
Cover page updated to include NCT 
Identification Number 
Section 3 updated to include 
Justification for Endpoints 
Section 9.1 updated to include 
additional paragraph to specify the 
changes in clinical database access 
after data is Hard Locked or Entry 
Locked 
Update to section 16.2 to change the 
Ref from MEDDEV to MDCG, and 
changes to the safety definitions to 
align with the updated guidance 
Update to section 16.3 to change the 
Ref from MEDDEV to MDCG, and 
changes to the AE definitions to align 
with the updated guidance 
Changes made to table 16.4-1 to align 
with the update guidance 
Various minor terminology updates 
throughout 
 
Update to incorporate the changes 
made to the protocol template 
92120219 from Ver. C to Ver. G. 
 
 
 
 

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Protocol Synopsis 
Global Prospective Case Series using a Single-Use Duodenoscope 
Exalt DScope 02 
E7156 
Study 
Objective(s) 
Confirm procedural performance of the ExaltTM Model D Single-Use 
Duodenoscope in Endoscopic Retrograde Cholangio-Pancreatography 
(ERCP) and other duodenoscope-based procedures 
Indication(s) for 
Use  
Single-Use Duodenoscope 
The device is intended for use with the Controller, for endoscopy and 
endoscopic surgery within the duodenum. 
Video Imaging System Controller 
The device is intended for use with a Boston Scientific endoscope for 
endoscopic diagnosis, treatment, and video observation. 
Study Device 
and sizes, if 
applicable  
ExaltTM Model D Single-Use Duodenoscope 
ExaltTM Controller 
Study Design 
Prospective case series of per standard of care ERCP procedures or other 
duodenoscope-based procedures 
Planned 
Number of 
Subjects 
Up to 1000 subjects 
Planned 
Number of 
Investigational 
Sites 
Up to 40 sites 
 
 
Primary 
Endpoint 
Ability to complete the ERCP or other duodenoscope-based procedure 
for the intended indication(s) 
Secondary 
Endpoints 
1. Document endoscopist rating of the Exalt single-use duodenoscope 
compared to marketed reusable duodenoscopes as it pertains to 
various design and performance related attributes 

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Global Prospective Case Series using a Single-Use Duodenoscope 
Exalt DScope 02 
E7156 
2. Incidence of crossover from Exalt single-use duodenoscope to 
reusable duodenoscope 
3. Evaluation of serious adverse events (SAEs) related to the device 
and/or the procedure through 30 days after the ERCP or 
duodenoscope-based procedure 
Follow-up 
Schedule 
• Screening/Baseline 
• Index Procedure 
• 72-hr Follow-Up Visit 
• 30 day Follow-Up Visit 
Participant 
Duration 
The study duration for each subject is expected to be approximately 1 
month 
Inclusion 
Criteria 
1. 18 years or older 
2. Willing and able to comply with the study procedures and provide 
written informed consent to participate in the study 
3. Scheduled for a clinically indicated ERCP or other duodenoscope-
based procedure 
Exclusion 
Criteria 
1. Potentially vulnerable subjects, including, but not limited to 
pregnant women 
2. Subjects for whom endoscopic techniques are contraindicated 
3. Subjects who are currently enrolled in another investigational study 
that would directly interfere with the current study, without prior 
written approval from the sponsor  
4. Investigator discretion 
Statistical Methods  
Statistical 
Hypothesis 
A statistical hypothesis is not required for this study as it is a case series 
of per standard of practice ERCP or other duodenoscope-based 
procedures 

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Table of Contents  
TITLE PAGE  ..............................................................................................................................1 
PROTOCOL SYNOPSIS ................................................................................................................6 
TABLE OF CONTENTS ................................................................................................................8 
Table of Tables ................................................................................................................11 
1. 
INTRODUCTION.................................................................................................................12 
1.1. Background ............................................................................................................12 
1.2. Study Rationale .....................................................................................................12 
2. 
STUDY DEVICE DESCRIPTION ..........................................................................................13 
3. 
STUDY OBJECTIVES AND ENDPOINTS ..............................................................................14 
4. 
STUDY DESIGN .................................................................................................................15 
4.1. Justification for the Study Design ........................................................................15 
5. 
SUBJECT SELECTION ........................................................................................................15 
5.1. Study Population and Eligibility ..........................................................................15 
5.2. Inclusion Criteria ..................................................................................................15 
5.3. Exclusion Criteria .................................................................................................15 
6. 
SUBJECT ACCOUNTABILITY .............................................................................................16 
6.1. Point of Enrollment ...............................................................................................16 
6.2. Withdrawal ............................................................................................................16 
6.3. Lost to Follow-Up ..................................................................................................16 
6.4. End-of-Study Definition........................................................................................17 
7. 
STUDY METHODS .............................................................................................................17 
7.1. Data Collection ......................................................................................................17 
7.2. Study Candidate Screening ..................................................................................17 
7.2.1. 
Strategies for Recruitment and Retention .................................................18 
7.3. Informed Consent..................................................................................................18 

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7.4. Baseline...................................................................................................................18 
7.5. Index Procedure ....................................................................................................18 
7.6. 72 hour (-1 day, + 2 days) and 30 day (± 3 days) Assessments ..........................18 
7.7. Study Completion ..................................................................................................18 
7.8. Source Documents .................................................................................................18 
8. 
STATISTICAL CONSIDERATIONS ......................................................................................19 
8.1. Statistical Hypothesis and sample size justification ...........................................19 
8.2. General Statistical Methods .................................................................................19 
8.2.1. 
Analysis Sets .............................................................................................19 
8.3. Data Analyses ........................................................................................................19 
8.3.1. 
Baseline Data ............................................................................................19 
8.3.2. 
Procedure Data ..........................................................................................19 
8.3.3. 
Post-Procedure Data .................................................................................20 
8.3.4. 
Interim Analyses .......................................................................................20 
9. 
DATA MANAGEMENT .......................................................................................................20 
9.1. Data Collection, Processing, and Review ............................................................20 
9.2. Data Retention .......................................................................................................20 
10. DEVIATIONS......................................................................................................................21 
11. COMMERCIAL DEVICE/EQUIPMENT ACCOUNTABILITY .................................................21 
12. DEVICE/EQUIPMENT ACCOUNTABILITY FOR PRODUCTS LABELED INVESTIGATIONAL
 
21 
13. COMPLIANCE ....................................................................................................................22 
13.1. Statement of Compliance ......................................................................................22 
13.2. Investigator Responsibilities ................................................................................22 
13.2.1. Delegation of Responsibility ....................................................................24 
13.3. Institutional Review Board/ Ethics Committee ..................................................24 
13.4. Sponsor Responsibilities .......................................................................................25 
13.4.1. Role of Boston Scientific Representatives ...............................................25 
13.5. Insurance ................................................................................................................26 
14. MONITORING ....................................................................................................................26 
15. POTENTIAL RISKS AND BENEFITS ...................................................................................27 

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15.1. Instructions for Use ...............................................................................................27 
15.2. Risks Associated with Participation in the Clinical Study ................................27 
15.3. Risk Minimization Actions ...................................................................................27 
15.4. Anticipated Benefits ..............................................................................................27 
15.5. Risk to Benefit Rationale ......................................................................................27 
16. SAFETY REPORTING .........................................................................................................27 
16.1. Reportable Events by Investigational Site to Boston Scientific ........................27 
16.2. Definitions and Classification...............................................................................28 
16.3. Relationship to Study Device(s) and/or Study Procedure .................................30 
16.4. Investigator Reporting Requirements .................................................................32 
16.5. Device Deficiencies ................................................................................................34 
16.6. Reporting to Regulatory Authorities / IRBs / ECs / REBs/ Investigators .......34 
17. INFORMED CONSENT ........................................................................................................34 
18. COMMITTEES ...................................................................................................................36 
18.1. Safety Monitoring Process ....................................................................................36 
19. SUSPENSION OR TERMINATION........................................................................................36 
19.1 Premature Termination of the Study ..................................................................36 
19.1.1 
Criteria for Premature Termination of the Study ......................................36 
19.2 Termination of Study Participation by the Investigator or Withdrawal of 
IRB/ EC /REB Approval ......................................................................................37 
19.3. Requirements for Documentation and Subject Follow-up ................................37 
19.4 Criteria for Suspending/Terminating a Study Site ............................................37 
20. STUDY REGISTRATION AND RESULTS .............................................................................37 
20.1. Study Registration .................................................................................................37 
20.2. Clinical Investigation Report ...............................................................................38 
20.3. Publication Policy ..................................................................................................38 
21. REIMBURSEMENT AND COMPENSATION FOR SUBJECTS .................................................38 
21.1. Compensation for Subject’s Health Injury.........................................................38 
22. BIBLIOGRAPHY .................................................................................................................38 
23. ABBREVIATIONS AND DEFINITIONS .................................................................................40 

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23.1. Abbreviations.........................................................................................................40 
 
 
Table of Tables 
Table 3-1: Study Objectives and Endpoints ............................................................................ 14 
Table 5-1: Inclusion Criteria ................................................................................................... 15 
Table 5-2: Exclusion Criteria .................................................................................................. 16 
Table 7-1: Data Collection Schedule ...................................................................................... 17 
Table 16-1: Safety Definitions ................................................................................................ 28 
Table 16-2: Criteria for Assessing Relationship of Study Device or Procedure to Adverse 
Event .................................................................................................................... 30 
Table 16-3: Investigator Reporting Requirements .................................................................. 32 
Table 23-1: Abbreviations ...................................................................................................... 40 
 
 
 
 
 

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1. Introduction 
1.1. Background 
Flexible endoscopes are used globally for the diagnosis and treatment of diseases of the GI 
tract. These delicate instruments are used in Endoscopic Retrograde 
Cholangiopancreatography (ERCP) procedures, which are performed with side viewing 
endoscopes (duodenoscopes) that to date are all reusable devices.1 Given their reusability, 
these instruments must be reprocessed through high level disinfection (HLD) in order to 
prevent the spread of nosocomial infections2, although different levels of disinfection may be 
produced depending on disinfection method, device modification, and staff adherence to 
disinfection protocols.1,3-5 
 
In recent years there have been an increased number of nosocomial infection outbreaks traced 
to contaminated duodenoscopes used during ERCP procedures in many states throughout the 
US and Europe.3,6-8 Organisms involved in these recent outbreaks include Carbapenem-
resistant Enterobacteriaceae (CRE), including Escherichia coli, and Klebsiella pneumoniae.6 
Unfortunately, some of the cases linked to these outbreaks have proven to be fatal.8 
Typically, infections discovered post-ERCP procedures vary between 2%-4%9, but it is 
unclear whether these infections are caused by contaminated duodenoscopes or the 
procedure.6   
 
The gastrointestinal tract is a highly contaminated environment, and the intricate tip design 
and long, narrow working channels of modern duodenoscopes render them extremely 
difficult, if not impossible, to adequately clean.10 Even strict adherence to all HLD 
procedures results in a non-zero, although minimal, level of potentially infectious microbes.10 
This remains a large problem, and neither manufacturers or regulatory bodies, such as the 
FDA, were providing guidance for this. While these cases reported in the hospitals listed 
above occurred in 2012, several other cases emerged globally, and months later the FDA 
stated that they were warning manufacturers, monitoring, and providing closer surveillance 
in an effort to prevent further infections associated with contaminated duodenoscopes.11 The 
FDA mandated the three duodenoscope manufacturers in the US, Olympus, Pentax, and 
Fujifilm, conduct post-market surveillance studies to evaluate the rate of duodenoscope 
contamination with viable microorganisms after standard HLD in actual practice.  While the 
studies assumed a <0.4% contamination rate, the study revealed 5.4% of duodenoscopes 
interrogated for these studies remained contaminated with high concern microorganisms 
including E. coli and Pseudomonas aeruginosa.12 
1.2. Study Rationale 
Conventional reusable duodenoscopes have been identified as the source of multiple cases of 
fatal and non-fatal nosocomial infections throughout the US and Europe, despite adherence 
to duodenoscope sterilization and reprocessing guidelines.  In some cases, the infectious 
organisms were later identified as belonging to a family of bacteria that has a high level of 
resistance to conventional antibiotics, known as CRE.  The ExaltTM Model D Single-Use 

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Duodenoscope is the first  single-use disposable duodenoscope available on the open market, 
which does not need to be sterilized or reprocessed because they are only used for a single 
patient in one case before they are disposed of.  The availability of this device may save 
patient lives by removing a potential source of infection and save the healthcare system 
money used to treat the infections and to reprocess the devices.  
 
In April-May 2019, 60 patients were prospectively enrolled in a consecutive ERCP case 
series using the Exalt™ Model D Single-Use Duodenoscope.  The primary endpoint of this 
study was the ability to complete the ERCP or other duodenoscope-based procedure for the 
intended indication(s).  All 60 (100%) ERCPs were completed, 58 (97%) using the single-use 
duodenoscope only, and 2 (3%) with crossover to a reusable duodenoscope.  
2. Study Device Description 
The Exalt™ Model D Single-Use Duodenoscope is a sterile, single-use endoscope that 
facilitates access to the duodenum, delivery of accessories, and live video when connected to 
an Exalt™ Controller.  
The Exalt™ Controller is an electronic device that:  
• Receives video signals from a Boston Scientific single-use endoscope,  
• Processes the video signals,  
• Outputs video images to a video monitor, and  
• Outputs electrical signal(s) that interface with external image capture systems.  
The Controller also controls the light transmitted by the tip of the single-use endoscope to 
illuminate the area of interest within the anatomy. Buttons on the Controller’s front panel 
enable the user to control the brightness level of the light.  
To use the Controller, connect it to a video monitor with a video cable and then connect a 
Boston Scientific single-use endoscope to the Controller. The Controller provides direct 
visualization during an endoscopic procedure.  
The Controller interfaces with external media capture equipment via the Controller’s rear 
panel connectors. Image capture is initiated via a button on the Boston Scientific single-use 
endoscope. The Controller sends a signal to the video monitor notifying the user that an 
image capture has been initiated. Directions for use for the Exalt™ Model D Single-Use 
Duodenoscope and Exalt™ Controller will be supplied separately to the investigational site 
in a regulatory binder. Investigators will use the device in accordance with the supplied 
directions and their institutional standard of care. 

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3. Study Objectives and Endpoints 
Table 3-1: Study Objectives and Endpoints 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary Endpoints 
 
 
To confirm procedural 
performance of the ExaltTM 
Model D Single-Use 
Duodenoscope in 
Endoscopic Retrograde 
Cholangio-Pancreatography 
(ERCP) and other 
duodenoscope-based 
procedures 
 
The primary endpoint is the ability 
to complete the ERCP procedures 
for the intended indication(s). 
 
Completion of ERCP and 
other duodenoscope based 
procedures is the standard 
measurement of the 
performance of a 
duodenoscope. This endpoint 
will indicate that these 
procedures can be achieved 
with the Exalt duodenoscope. 
 
 
Secondary Endpoints 
 
 
To confirm procedural 
performance of the ExaltTM 
Model D Single-Use 
Duodenoscope in 
Endoscopic Retrograde 
Cholangio-Pancreatography 
(ERCP) and other 
duodenoscope-based 
procedures 
 
The following will be recorded as 
secondary endpoints during index 
procedure through follow-up: 
1. Document endoscopist rating 
of the Exalt single-use 
duodenoscope compared to 
marketed reusable 
duodenoscopes as it pertains to 
various design and 
performance related attributes. 
2. Incidence of crossover from 
Exalt single-use duodenoscope 
to reusable duodenoscope. 
3. Evaluation of serious adverse 
events (SAEs) related to the 
device and/or the procedure 
through 30 days after the 
ERCP or other duodenoscope 
based procedures 
 
1. Endoscopist rating of the 
study device provide a 
subjective evaluation of 
the device performance by 
intended users. 
2. The ability to complete the 
index procedure with the 
Exalt duodenoscope is an 
important indicator of the 
performance of the device. 
3. Serious adverse events are 
being collected at 30 days 
in order to detect any 
event with a late onset and 
to document the safety 
profile of the study device. 
 

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4. Study Design 
This is a prospective, multi-center case series of standard of care ERCP procedures and other 
duodenoscope-based procedures with up to 1000 subjects. This study represents the post-
market clinical development stage of the study device according to ISO 14155.  The 
endoscopist will use the Exalt single-use duodenoscope in place of the reusable 
duodenoscope normally used in the endoscopy unit at their own discretion.   
4.1. Justification for the Study Design 
The study is designed to demonstrate that physicians are able to complete standard of care 
ERCP procedures and other duodenoscope-based procedures with the Exalt Model D single-
use duodenoscope.  The Exalt duodenoscope is designed to perform similarly to conventional 
marketed reusable duodenoscopes. 
5. Subject Selection  
5.1. Study Population and Eligibility  
All inclusion and exclusion criteria below must be verified during screening. 
5.2. Inclusion Criteria 
Subjects who meet all of the following criteria (see Table 5-1) may be given consideration 
for inclusion in this clinical investigation, provided no exclusion criterion (see Section 5.3) is 
met.  
Table 5-1: Inclusion Criteria 
Inclusion 
Criteria 
1. 18 years or older 
2. Willing and able to comply with the study procedures and provide written informed 
consent to participate in the study 
3. Schedule for a clinically indicated ERCP or other duodenoscope-based procedure 
 
5.3. Exclusion Criteria 
Subjects who meet any one of the following criteria (Table 5-2) cannot be included in this 
study or will be excluded from this clinical study. 

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Table 5-2: Exclusion Criteria 
Exclusion 
Criteria 
1. Potentially vulnerable subjects, including, but not limited to pregnant women 
2. Subjects for whom endoscopic techniques are contraindicated 
3. Subjects who are currently enrolled in another investigational study that would directly 
interfere with the current study, without prior written approval from the sponsor  
4. Investigator discretion 
 
6. Subject Accountability 
6.1. Point of Enrollment 
Subjects will be considered enrolled into the study at the time of the study-specific informed 
consent form (ICF) execution. Subjects who have signed informed consent but do not 
undergo the study procedure are considered screen failures. Screen failures will be recorded 
in the Electronic Data Capture (EDC) by each study site and will not count toward total study 
enrollment. 
In the case it is determined that the subject failed to meet the inclusion/exclusion criteria after 
the subject has agreed to participate in the study and has signed the informed consent, the 
study personnel will complete the Screening form and the End of Study form.  
6.2. Withdrawal 
Subjects will participate in the study voluntarily and may withdraw at any time without 
prejudice to further treatment. All subjects enrolled in the clinical study (including those 
withdrawn from the clinical study) shall be accounted for and documented. If a subject 
withdraws from the clinical investigation, the reason(s) shall be reported. If such withdrawal 
is due to problems related to  study device safety or performance, the investigator shall ask 
for the subject’s permission to follow his/her status/condition outside of the clinical study.   
 
Applicable case report forms up to the point of subject withdrawal, including an End of 
Study form must be completed.  Unless the withdrawal is due to a Serious Adverse Event, 
additional subject data will not be collected after the point at which the subject has been 
withdrawn or withdraws consent from the study. Data collected up to the point of withdrawal 
may be used by the investigators as permitted in the ICF. 
6.3. Lost to Follow-Up 
A subject will be considered lost to follow-up if he/she fails to return for their scheduled 
follow-up visits and is unable to be contacted by the study site staff after at least three 
documented attempts, at which point an End of Study form should be completed.  Before a 
participant is deemed lost to follow up, the investigator or designee will make every effort to 
regain contact with the participant (where possible, 3 telephone calls and, if necessary, a 
certified letter to the participant’s last known mailing address or local equivalent methods).  

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These contact attempts should be documented in the participant’s medical record or study 
file. 
6.4. End-of-Study Definition  
A clinical trial is considered completed when participants are no longer being examined or 
the last participant’s last study visit has occurred.  
Subjects will be followed through 30 days post index procedure. At study completion, an End 
of Study form will be completed. The end of study is defined as completion of the last visit 
or a reason for the last study visit not having been completed has been determined by the 
investigator or designee. If the last follow-up visit was not completed, the investigator will 
note the reason on the study completion form (e.g. subject withdrawn by investigator, subject 
withdrew consent, lost to follow-up, AE, death, etc.). 
7. Study Methods 
7.1. Data Collection 
The data collection schedule is shown in Table 7-1. 
Table 7-1: Data Collection Schedule 
Procedure/Assessment 
Screening 
Baseline 
Index 
Procedure 
Follow-up Visits 
72-hour visit 
(-1, +2  Days) 
Office/ 
Telephone 
Day 30 visit 
(± 3 Days) 
Office/ 
Telephone 
Informed consent process, 
including informed consent 
signature date 
X 
 
 
 
 
Demographics, Medical 
History 
 
X 
 
 
 
Index Procedure 
 
 
X 
 
 
Maneuvers 
 
 
X 
 
 
Exalt Evaluation 
 
 
X 
 
 
Device Event Assessment 
 
 
X 
 
 
Adverse Event Assessment 
 
 
X 
X 
X 
End of Study 
 
 
 
 
X 
X=required 
 
 
 
 
 
7.2. Study Candidate Screening 
Subjects who are clinically indicated for an ERCP or other duodenoscope-based procedure 
and meet the listed eligibility criteria may be screened for trial enrollment. All patients who 
are considered for enrollment but not enrolled will be recorded. 

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7.2.1. Strategies for Recruitment and Retention 
All patients under the care of a study investigator during the enrollment period of a site will 
be considered for recruitment. 
7.3. Informed Consent 
Data collection and/or study procedure will not occur prior to the subject signing the ICF. 
Patients will be considered enrolled in the study once they sign the informed consent. Once a 
subject is considered enrolled in the study, baseline information may be obtained. 
7.4. Baseline 
Baseline information will include the following data points: age at time of consent, gender, 
and relevant medical history. 
7.5. Index Procedure 
During the index procedure, the endoscopist or designated member of study staff will record: 
start and stop times of procedure, scope information, whether certain types of medicine were 
administered, and any activities completed or attempted during the procedure, regardless of 
original intent.  Any ensuing device events will be recorded and reported. 
After the ERCP procedure has been completed, the endoscopist will rate their experience 
using the Exalt device during the index procedure. 
7.6. 72 hour (-1 day, + 2 days) and 30 day (± 3 days) Assessments 
All enrolled subjects will be seen in person or evaluated via telephone to screen for any post-
procedure adverse events, and to evaluate the resolution of any previously noted adverse 
events or sequelae, as applicable. 
7.7. Study Completion 
Subjects will be followed for 30 days (± 3 days) post index procedure. Subjects will continue 
to receive care from their doctor as they normally would. At study completion, an End of 
Study form will be completed, indicating whether the subject completed the study. If the last 
follow-up visit was not completed, the reason will be noted on the study completion form 
(e.g. subject withdrawn by investigator, subject withdrew consent, lost to follow-up, AE, 
death, etc.).  
7.8. Source Documents 
It is preferable that original source documents are maintained, when available. In lieu of 
original source documents, certified copies are required to be maintained.  A certified copy is 
a copy (irrespective of the type of media used) of the original record that has been verified 

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(i.e., by a dated signature or by generation through a validated process) to have the same 
information, including data that describe the context, content, and structure, as the original. 
8. Statistical Considerations 
8.1. Statistical Hypothesis and sample size justification 
A statistical hypothesis is not required for this study as it is a case series of per standard of 
practice ERCP or other duodenoscope-based procedures. 
8.2. General Statistical Methods 
8.2.1. Analysis Sets 
Enrolled Cohort 
A subject is considered enrolled after signing the study-specific ICF.  Subjects who sign the 
ICF, but subsequently do not meet one or more of the eligibility criteria provided in Section 
5.2and Section 5.3 will be considered screen failures and excluded from the study.   
Intent-to-Treat Cohort (ITT) 
This cohort consists of enrolled subjects who meet all eligibility criteria and are planned to 
have an ERCP or other duodenoscope based procedure using Exalt duodenoscope. 
Treated Cohort 
The treated cohort is a subset of the ITT subjects who have an ERCP or other duodenoscope 
based procedure using the Exalt duodenoscope. 
8.3. Data Analyses 
All statistical analyses will be done using The SAS System software, version 8 or higher 
(Copyright © 2000 SAS Institute Inc., SAS Campus Drive, Cary, North Carolina 27513, 
USA. All rights reserved). 
8.3.1. Baseline Data 
Subject demographics and clinical history will be summarized using descriptive statistics 
(e.g., mean, standard deviation, n, minimum, maximum) for continuous variables and 
frequency statistics for discrete variables.  
8.3.2. Procedure Data 
Procedure data including qualitative evaluation will be collected and reported using 
descriptive statistics (e.g., mean, standard deviation, n, minimum, maximum) for continuous 
variables and frequency statistics for discrete variables. 

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8.3.3. Post-Procedure Data 
Post-procedure information will be collected as detailed in the Table 7.1-1. Data Schedule and 
will be summarized using descriptive statistics for continuous variables (e.g., mean, standard 
deviation, n, minimum, maximum) and frequency statistics for discrete variables.   
8.3.4. Interim Analyses 
No formal interim analyses are planned for this study. 
9. Data Management 
9.1. Data Collection, Processing, and Review 
Subject data will be recorded in the Medidata Rave limited access secure electronic data 
capture (EDC) system.  
The clinical database will reside on a production server hosted by Medidata. All changes 
made to the clinical data will be captured in an electronic audit trail and available for review 
by the sponsor or its representative. The associated Rave software and database have been 
designed to meet regulatory compliance for deployment as part of a validated system 
compliant with laws and regulations applicable to the conduct of clinical studies pertaining to 
the use of electronic records and signatures. Database backups are performed regularly. 
The Investigator provides his/her electronic signature on the appropriate electronic case 
report forms (eCRFs) in compliance with local regulations. A written signature on printouts 
of the eCRFs must also be provided if required by local regulation. Changes to data 
previously submitted to the sponsor require a new electronic signature by the Investigator 
acknowledging and approving the changes. 
Visual and/or electronic data review will be performed to identify possible data 
discrepancies. Manual and/or automatic queries will be created in the Medidata EDC system 
for site response. Site staff will be responsible for resolving queries in the database. 
All access to the clinical database will be changed to “Read only” after all data is either 
“Hard Locked” or “Entry Locked”. Once acceptance of the final report or finalization of 
publications (as applicable) is received, final database storage and archiving activities can 
begin. Once all of the closeout activities are completed a request to IT is submitted to have 
the “Database Locked” or Decommissioned and all database access revoked. 
 
9.2. Data Retention 
The Principal Investigator or his/her designee or Investigational site will maintain all 
essential study documents and source documentation that support the data collected on the 
study subjects in compliance with applicable regulatory requirements.   

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The Principal Investigator or his/her designee will take measures to prevent accidental or 
premature destruction of these documents. If for any reason the Principal Investigator or 
his/her designee withdraws responsibility for maintaining these essential documents, custody 
must be transferred to an individual who will assume responsibility and BSC must receive 
written notification of this custodial change. Sites are required to inform Boston Scientific in 
writing where paper or electronic files are maintained in case files are stored off site and are 
not readily available. 
10. Deviations 
An Investigator must not make any changes or deviate from this protocol, except to protect 
the life and physical well-being of a subject in an emergency. An investigator shall notify the 
sponsor and the reviewing IRB/EC/REB, and the regulatory authority if applicable of any 
deviation from the investigational plan to protect the life or physical well-being of a subject 
in an emergency, and those deviations which affect the scientific integrity of the clinical 
investigation. Such notice shall be given as soon as possible, but no later than 5 working days 
after the emergency occurred, or per prevailing local requirements, if sooner than 5 working 
days.  
Deviations from the investigational plan, with the reason for the deviation must be 
documented and reported to the sponsor via EDC. Sites may also be required to report 
deviations to the IRB/EC/REB, and the local regulatory authority, per local guidelines and 
national/government regulations.  
Deviations will be reviewed and evaluated on an ongoing basis and, as necessary, appropriate 
corrective and preventive actions (including IRB/EC/REB/Regulatory Authority/FDA 
notification, site re-training, or site discontinuation/termination) will be put into place by the 
sponsor. 
 
11. Commercial Device/Equipment Accountability  
The study devices/equipment owned by Boston Scientific shall be securely maintained, 
controlled, and used only in this clinical study. The Inventory Management Record will be 
used to track subjects and study device allocations during the study for study devices not 
labeled investigational. Equipment owned by Boston Scientific shall be returned in the 
condition in which it was provided, reasonable wear and tear excepted. 
12. Device/Equipment Accountability for Products Labeled 
Investigational 
The investigational devices/equipment shall be securely maintained, controlled, and used 
only in this clinical study. The Device Accountability Log will be used to track subjects and 
device allocations during the study for study devices labeled investigational. Equipment shall 
be returned in the condition in which it was provided, reasonable wear and tear excepted. 

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The sponsor shall keep records to document the physical location of all study devices/ 
equipment from shipment of study devices from BSC or designated facility/equipment to the 
investigation sites until return or disposal. 
Records shall be kept by the site to document the physical location and conditions of storage 
of all study devices/equipment.  
The principal investigator or an authorized designee shall keep records documenting the 
receipt, use, return and disposal of the  study devices/equipment, which shall include the 
following 
• Date of receipt 
• Identification of each study device/piece of equipment (batch number or unique code) 
• Expiry date, as applicable 
• Date or dates of use 
• Subject identification 
• Date on which the study device/piece of equipment was returned/explanted from subject, 
if applicable 
• Date of return (and number) of unused, expired, or malfunctioning study 
devices/equipment, if applicable. 
13. Compliance 
13.1. Statement of Compliance 
This clinical investigation is financed by the study sponsor. Before the investigational site 
can be “Authorized to Enroll,” the investigational site must enter into a Clinical Study 
Agreement with the sponsor that details the financing of the study as well as the rights and 
obligations of the investigational site and the investigator. This study will be conducted in 
accordance with European Medical Device Regulation, ISO 14155: Clinical Investigation of 
Medical Devices for Human Subjects – Good Clinical Practice, ICH Guidelines for GCP, 
ethical principles that have their origins in the Declaration of Helsinki, and applicable 
individual country laws and regulations. The study shall not begin until the required 
approval/favorable opinion from the IRB/EC/REB and/or regulatory authority has been 
obtained, if appropriate. Also, the study shall not begin prior to issuance of the site 
Authorization to Enroll, as provided by the sponsor. Any additional requirements imposed by 
the IRB/EC/REB or regulatory authority shall be followed, if appropriate.  
13.2. Investigator Responsibilities 
The Principal Investigator of an investigational site is responsible for ensuring that the study 
is conducted in accordance with the Clinical Study Agreement, the clinical investigation 
plan, ISO 14155, ethical principles that have their origins in the Declaration of Helsinki, any 
conditions of approval imposed by the reviewing IRB/EC/REB, and prevailing local and/or 
country laws and/or regulations, whichever affords the greater protection to the subject. 
The Principal Investigator’s responsibilities include, but are not limited to, the following.  

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• Prior to beginning the study, sign the Clinical Study Agreement and comply with the 
Investigator responsibilities as described in such Agreement.   
• Prior to beginning the study, sign the Investigator Brochure Signature Page (if applicable) 
and Protocol Signature page documenting his/her agreement to conduct the study in 
accordance with the protocol. 
• Provide his/her qualifications and experience to assume responsibility for the proper 
conduct of the study and that of key members of the site team through up-to-date 
curriculum vitae or other relevant documentation and disclose potential conflicts of 
interest, including financial, that may interfere with the conduct of the clinical study or 
interpretation of results. 
• Make no changes in or deviate from this protocol, except to protect the life and physical 
well-being of a subject in an emergency; document and explain any deviation from the 
approved protocol that occurred during the course of the clinical investigation. 
• Create and maintain source documents throughout the clinical study and ensure their 
availability with direct access during monitoring visits or audits; ensure that all clinical-
investigation-related records are retained per requirements. 
• Ensure the accuracy, completeness, legibility, and timeliness of the data reported to the 
sponsor in the CRFs and in all required reports. 
• Record, report, and assess (seriousness and relationship to the device/procedure) every 
adverse event as applicable per the protocol and observed device deficiency. 
• Report to sponsor, per the protocol requirements, all reportable events. 
• Report to the IRB/EC/REB and regulatory authorities any SAEs and device deficiencies 
that could have led to a SADE and potential/USADE or UADE, if required by applicable 
laws or regulations or this protocol or by the IRB/EC/REB, and supply BSC with any 
additional requested information related to the safety reporting of a particular event. 
• Maintain records and control of the device, ensuring that the study device is used only by 
authorized/designated users and in accordance with this protocol and 
instructions/directions for use. 
• Allow the sponsor to perform monitoring and auditing activities; be accessible to the 
clinical research monitor or auditor and respond to questions during monitoring visits or 
audit(s). 
• Allow and support regulatory authorities and the IRB/EC/REB when performing auditing 
activities. 
• Ensure that informed consent is obtained in accordance with applicable laws, this 
protocol and local IRB/EC/REB requirements. 
• Provide adequate medical care to a subject during and after a subject’s participation in a 
clinical study in the case of adverse events, as described in the Informed Consent Form 
(ICF). 

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• Inform the subject of the nature and possible cause of any adverse events experienced. 
• As applicable, provide the subject with necessary instructions on proper use, handling, 
storage, and return of the  study device when it is used/operated by the subject. 
• Inform the subject of any new significant findings occurring during the clinical 
investigation, including the need for additional medical care that may be required. 
• Provide the subject with well-defined procedures for possible emergency situations 
related to the clinical study, and make the necessary arrangements for emergency 
treatment, including decoding procedures for blinded/masked clinical investigations, as 
needed. 
• Ensure that clinical medical records are clearly marked to indicate that the subject is 
enrolled in this clinical study. 
• Ensure that, if appropriate, subjects enrolled in the clinical investigation are provided 
with some means of showing their participation in the clinical investigation, together with 
identification and compliance information for concomitant treatment measures (contact 
address and telephone numbers shall be provided). 
• Inform, with the subject’s approval or when required by national regulations, the 
subject’s personal physician about the subject’s participation in the clinical investigation. 
• Make all reasonable efforts to ascertain the reason(s) for a subject’s premature 
withdrawal from clinical investigation while fully respecting the subject’s rights. 
• Ensure that an adequate investigation site team and facilities exist and are maintained and 
documented during the clinical investigation. 
All investigators will provide their qualifications and experience to assume responsibility for 
their delegated tasks through up-to-date curriculum vitae or other relevant documentation and 
disclose potential conflicts of interest, including financial, that may interfere with the conduct 
of the clinical study or interpretation of results. 
13.2.1. Delegation of Responsibility 
When specific tasks are delegated by an investigator, including but not limited to conducting 
the informed consent process, the Principal Investigator is responsible for providing 
appropriate training, are competent to perform the tasks they have been delegated and 
adequate supervision of those to whom tasks are delegated. Where there is a sub investigator 
at a site, the sub investigator should not be delegated the primary supervisory responsibility 
for the site. The investigator is accountable for regulatory violations resulting from failure to 
adequately supervise the conduct of the clinical study.  
13.3. Institutional Review Board/ Ethics Committee 
The investigational site will obtain the written and dated approval/favorable opinion of the 
IRB/EC/REB for the clinical investigation before recruiting subjects and implementing all 
subsequent amendments, if required. 

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A copy of the written IRB/EC/REB and/or competent authority (CA) approval of the 
protocol (or permission to conduct the study) and ICF, must be received by the sponsor 
before recruitment of subjects into the study and shipment of study product/equipment. Prior 
approval must also be obtained for other materials related to subject recruitment or which 
will be provided to the subject. 
Any amendment to the protocol will require review and approval by the IRB/EC/REB before 
the changes are implemented to the study.  All changes to the ICF will be IRB/EC/REB 
approved; a determination will be made regarding whether a new ICF needs to be obtained 
from participants who provided consent, using a previously approved ICF. Annual 
IRB/EC/REB approval and renewals will be obtained throughout the duration of the study as 
required by applicable local/country laws or regulations or IRB/EC/REB requirements. 
Copies of the study reports and the IRB/EC/REB continuance of approval must be provided 
to the sponsor.  
13.4. Sponsor Responsibilities 
All information and data sent to BSC concerning subjects or their participation in this study 
will be considered confidential by BSC and will be kept confidential in accordance with all 
applicable laws and regulations. Only authorized BSC personnel and/or a BSC representative 
including, but not limited to Contract Research Organization (CRO), will have access to this 
information. Authorized regulatory personnel have the right to inspect and copy all records 
pertinent to this study. Study data collected during this study may be used by BSC for the 
purposes of this study, publication, and to support future research and/or other business 
purposes, such as overseeing and improving the performance of its device, new medical 
research and proposals for developing new medical products and procedures. All data used in 
the analysis and reporting of this study or shared with a third-party researcher will be without 
identifiable reference to specific subjects. 
Information received during the study will not be used to market to subjects; subject names 
will not be placed on any mailing lists or sold to anyone for marketing purposes.  
13.4.1. Role of Boston Scientific Representatives 
Boston Scientific personnel can provide technical support to the investigator and other health 
care personnel (collectively HCP) as needed. Support may include, but is not limited to, HCP 
training, addressing HCP questions, or providing clarifications to HCPs concerning the 
operation of BSC equipment/devices (including programmers, analyzers, and other support 
equipment). 
At the request of the investigator and while under investigator supervision, BSC personnel 
may operate equipment, assist with the conduct of testing specified in the protocol, and 
interact with the subject to accomplish requested activities.  
Typical tasks may include the following: 
• Provide instructions for the safe return of products. For potentially hazardous items, 
provide specialized instructions and materials, as applicable. 

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• Clarifying device behavior, operation or diagnostic output as requested by the 
investigator or other health care personnel 
• Entering technical data on technical source form as long as the responsible investigator 
verifies and signs the completed form  
• Provide technical expertise/support to subjects during office visits and/or during 
teleconference calls/electronic communications with the principal investigator or their 
delegated site staff and the subject.  
In addition, BSC personnel may perform certain activities to ensure study quality. These 
activities may include the following. 
• Observing testing or medical procedures to provide information relevant to protocol 
compliance 
• Reviewing collected data and study documentation for completeness and accuracy 
Boston Scientific personnel will not do the following.  
• Practice medicine 
• Provide medical diagnosis or treatment to subjects 
• Discuss a subject’s condition or treatment with a subject  
• Independently collect critical study data (defined as primary or secondary endpoint data) 
• Enter data in electronic data capture systems or on paper case report forms 
13.5. Insurance  
Where required by local/country regulation, proof and type of insurance coverage, by BSC 
for subjects in the study will be obtained. 
14. Monitoring 
Monitoring will be performed during the study to assess continued compliance with the 
protocol and applicable regulations. In addition, the clinical research monitor verifies that 
study records are adequately maintained, that data are reported in a satisfactory manner with 
respect to timeliness, adequacy, and accuracy, and that the Principal Investigator continues to 
have sufficient staff and facilities to conduct the study safely and effectively. The Principal 
Investigator/institution guarantees direct access to original source documents by BSC 
personnel, their designees, and appropriate regulatory authorities. 
The sponsor will put a plan in place to document the specific monitoring requirements.  
The study may also be subject to a quality assurance audit by BSC or its designees, as well as 
inspection by appropriate regulatory authorities. It is important that the Principal Investigator 
and relevant study personnel are available during on-site monitoring visits or audits and that 
sufficient time is devoted to the process. 

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15. Potential Risks and Benefits 
15.1. Instructions for Use 
Please refer to the Instructions for Use for an overview of anticipated (device) effects, and 
risks associated to the study device(s). 
15.2. Risks Associated with Participation in the Clinical Study 
Risk associated with participation in the Clinical Study are similar to that of an ERCP with 
standard duodenoscope. Participation in the trial may be time consuming.  
15.3. Risk Minimization Actions 
Additional risks may exist. Risks can be minimized through compliance with this protocol, 
performing procedures in the appropriate hospital environment, adherence to subject 
selection criteria, close monitoring of the subject's physiologic status during research 
procedures and/or follow-ups and by promptly supplying BSC with all pertinent information 
required by this protocol. 
15.4. Anticipated Benefits 
Recent literature has identified an outbreak with carbapenem-resistant Enterobacteriaceae 
(CRE).3-8 That endoscopic transmission of infection can be prevented by strict adherence to 
disinfection protocols has been challenged with no clearly identified protocol to reduce this 
risk.13  Use of a Single-Use Duodenoscope would alleviate the need for high level 
disinfection of the standard Duodenoscope, thereby reducing the risk of infection 
transmission between patients.  
  
15.5. Risk to Benefit Rationale 
Based on collected reports in literature to-date, the risk-to-benefit ratio is within reason for 
foreseeable risks. However, literature reports do not always capture all side effects. 
Observation and follow-up of patients is required as outlined in the protocol. 
16. Safety Reporting 
16.1. Reportable Events by Investigational Site to Boston Scientific 
It is the responsibility of the investigator to assess and report to BSC any event which occurs 
in any of following categories: 
• All Non-Serious Adverse Events 
• All Serious Adverse Events 
• All Study Device Deficiencies  

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• Unanticipated Adverse Device Effects/Unanticipated Serious Adverse Device Effects 
• New findings/updates in relation to already reported events 
When possible, the medical diagnosis should be reported as the Event Term instead of 
individual symptoms. 
If it is unclear whether or not an event fits one of the above categories, or if the event cannot 
be isolated from the device or procedure, it should be submitted as an adverse event and/or 
device deficiency. 
Any reportable event, experienced by the study subject after informed consent and once 
considered enrolled in the study (as defined in study subject classification section), whether 
during or subsequent to the procedure, must be recorded in the eCRF. 
Underlying diseases and chronic conditions are not reported as AEs unless there is an 
increase in severity or frequency during the course of the investigation. Death should not be 
recorded as an AE, but should only be reflected as an outcome of one (1) specific SAE (see 
Table 16-1 for AE definitions). 
Refer to Section 15 for the known risks associated with the study device(s). 
 
16.2. Definitions and Classification 
Adverse event definitions are provided in Table 16-1. Administrative edits were made on the 
safety definitions from ISO 14155 and EU 2017/745 for clarification purposes. 
Table 16-1: Safety Definitions 
Term 
Definition 
Adverse Event (AE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
 
 
 
Any untoward medical occurrence, unintended disease or injury, or any 
untoward clinical signs (including an abnormal laboratory finding) in 
subjects, users or other persons, in the context of a clinical investigation, 
whether or not related to the study medical device and whether anticipated 
or unanticipated. 
NOTE 1: This includes events related to the study medical device or 
comparator. 
NOTE 2: This definition includes events related to the procedures 
involved. 
NOTE 3: For users or other persons, this definition is restricted to events 
related to the study medical device.  
Adverse Device Effect (ADE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
Adverse event related to the use of an study medical device 
NOTE 1: This includes any adverse event resulting from insufficiencies 
or inadequacies in the instructions for use, the deployment, the 
implantation, the installation, the operation, or any malfunction of the 
study medical device. 
NOTE 2: This definition includes any event resulting from use error or 
from intentional misuse of the study medical device. 
NOTE 3: This includes ‘comparator’ if the comparator is a medical 
device. 

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Table 16-1: Safety Definitions 
Term 
Definition 
Serious Adverse Event (SAE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
Adverse event that led to any of the following: 
a) death, 
b) serious deterioration in the health of the subject, user or other persons 
as defined by either: 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, 
including chronic diseases, or 
3) in-patient hospitalization or prolongation of existing 
hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness 
or injury or permanent impairment to a body structure or a body 
function 
c) foetal distress, foetal death, or a congenital abnormality or birth defect 
including physical or mental impairment. 
NOTE 1: Planned hospitalization for a pre-existing condition, or a 
procedure required by the clinical investigational plan, without a serious 
deterioration in health, is not considered a serious adverse event.  
Serious Adverse Device Effect 
(SADE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
Adverse device effect that has resulted in any of the consequences 
characteristic of a serious adverse event. 
 
Unanticipated Adverse Device 
Effect (UADE) 
 
Ref: 21 CFR Part 812 
 
 
Any serious adverse effect on health or safety or any life-threatening 
problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or 
degree of incidence in the investigational plan or application (including a 
supplementary plan or application), or any other unanticipated serious 
problem associated with a device that relates to the rights, safety, or 
welfare of subjects.   
Unanticipated Serious Adverse 
Device Effect (USADE) 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
 
 
Serious adverse device effect which by its nature, incidence, severity, or 
outcome has not been identified in the current risk assessment. 
NOTE 1: Anticipated serious adverse device effect (ASADE) is an effect 
which by its nature, incidence, severity or outcome has been identified in 
the risk assessment. 
Serious Health Threat 
 
Ref: ISO 14155 
 
Signal from any adverse event or device deficiency that indicates an  
imminent risk of death or a serious deterioration in the health in subjects, 
users or other persons, and that requires prompt remedial action 
for other subjects, users or other persons. 
NOTE 1: This would include events that are of significant and 
unexpected nature such that they become alarming as a potential 
serious health hazard or possibility of multiple deaths occurring at 
short intervals. 

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Table 16-1: Safety Definitions 
Term 
Definition 
Device Deficiency 
 
Ref: ISO 14155 
 
Ref: MDCG 2020-10/1 
An inadequacy of a medical device related to its identity, quality, 
durability, reliability, usability, safety or performance.  
NOTE 1: Device deficiencies include malfunctions, use errors, and 
inadequacy in the information supplied by the manufacturer including 
labelling. 
NOTE 2: This definition includes device deficiencies related to the 
investigational medical device or the comparator. 
The following definitions will be used for defining hospitalization or prolongation of hospitalization for SAE 
classification purposes: 
Hospitalizations  
Hospitalization does not include: 
• 
emergency room visit that does not result in in-patient admission  
Note: although an emergency room visit does not itself meet the 
definition for hospitalization, it may meet other serious criteria 
(e.g. medical or surgical intervention to prevent permanent 
impairment or damage) 
• 
elective and pre-planned treatment/surgery for a pre-existing 
condition that is documented in the subject’s record at the time of 
consent/enrollment 
• 
admission for social reasons and/or respite care in the absence of 
any deterioration in the subject’s general condition (e.g. subject is 
homeless, caregiver relief) 
• 
pre-planned, protocol-specified admission related to the clinical 
study (e.g. procedure required by protocol) 
Prolongation of hospitalization  
In-patient admission to the hospital that is prolonged beyond the expected 
standard duration for the condition under treatment. 
Note: new adverse events occurring during the hospitalization are 
evaluated to determine if they prolonged hospitalization or meet other 
SAE criteria. 
 
16.3. Relationship to Study Device(s) and/or Study Procedure 
The Investigator must assess the relationship of the reportable AE to the study device, and/or 
study procedure. See criteria in Table 16-2:  
Table 16-2: Criteria for Assessing Relationship of Study Device or Procedure to 
Adverse Event 
Classification 
Description 
Not Related 
Ref:  MDCG 2020-
10/1 
Relationship to the device, comparator or procedures can be excluded when: 
- the event has no temporal relationship with the use of the study device or the 
procedures related to the use of the study device; 
- the serious event does not follow a known response pattern to the medical device 
(if the response pattern is previously known) and is biologically implausible; 

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Table 16-2: Criteria for Assessing Relationship of Study Device or Procedure to 
Adverse Event 
Classification 
Description 
- the discontinuation of medical device application or the reduction of the level of 
activation/exposure - when clinically feasible – and reintroduction of its use (or 
increase of the level of activation/exposure), do not impact on the serious event; 
- the event involves a body-site or an organ that cannot be affected by the device or 
procedure; 
- the serious event can be attributed to another cause (e.g. an underlying 
or concurrent illness/ clinical condition, an effect of another device, drug, treatment 
or other risk factors); 
- the event does not depend on a false result given by the study device used for 
diagnosis, when applicable;  
- In order to establish the non-relatedness, not all the criteria listed above might be 
met at the same time, depending on the type of device/procedures and the serious 
event. 
Possibly Related 
Ref:  MDCG 2020-
10/1 
The relationship with the use of the study device or comparator, or the relationship 
with procedures is weak but cannot be ruled out completely. Alternative causes are 
also possible (e.g. an underlying or concurrent illness/ clinical condition or/and an 
effect of another device, drug or treatment). Cases where relatedness cannot be 
assessed or no information has been obtained should also be classified as possible. 
Probably Related 
Ref:  MDCG 2020-
10/1 
The relationship with the use of the study device or comparator, or the relationship 
with procedures seems relevant and/or the event cannot be reasonably explained by 
another cause,  
Causal Relationship 
Ref:  MDCG 2020-
10/1 
The serious event is associated with the study device or comparator or with 
procedures beyond reasonable doubt when: 
- the event is a known side effect of the product category the device belongs to or 
of similar devices and procedures; 
- the event has a temporal relationship with  study device use/application or 
procedures; 
- the event involves a body-site or organ that 
-the  study device or procedures are applied to; 
-the study device or procedures have an effect on; 
- the serious event follows a known response pattern to the medical device (if the 
response pattern is previously known); 
- the discontinuation of medical device application (or reduction of the level of 
activation/exposure) and reintroduction of its use (or increase of the level of 
activation/exposure), impact on the serious event (when clinically feasible); 
- other possible causes (e.g. an underlying or concurrent illness/ clinical condition 
or/and an effect of another device, drug or treatment) have been adequately ruled 
out; 
- harm to the subject is due to error in use; 
- the event depends on a false result given by the  study device used for diagnosis, 
when applicable; 
- In order to establish the relatedness, not all the criteria listed above might be met 
at the same time, depending on the type of device/procedures and the serious event. 

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16.4. Investigator Reporting Requirements 
The communication requirements for reporting to BSC are as shown in Table 16-3. 
 
Table 16-3: Investigator Reporting Requirements 
 
Event Classification 
Communication 
Method  
Communication Timeline pre-
market studies 
(21 CFR Part 812, MDCG 
2020-10/1) 
Communication Timeline post-
market studies 
(EU MDR 2017/745, MDCG 
2020-10/1 
MEDDEV 2.12/1:  
GUIDELINES ON A MEDICAL 
DEVICE VIGILANCE SYSTEM) 
 
 
 
 
 
 
 
Unanticipated Adverse 
Device Effect / 
Unanticipated Serious 
Adverse Device Effect  
 
Complete AE eCRF 
page with all available 
new and updated 
information.  
 
• Within 1 business day of first 
becoming aware of the event. 
• Terminating at the end of the 
study 
• Within 1 business day of first 
becoming aware of the event  
• Terminating at the end of the 
study 
 
Provide all relevant 
source documentation 
(de-identified/ 
pseudonymized) for 
reported event.  
• Upon request of sponsor.  
• At request of sponsor. 
Serious Adverse Event  
Complete AE eCRF 
page with all available 
new and updated 
information.  
• Within 3 calendar days of first 
becoming aware of the event or 
as per local/regional 
regulations.  
• Reporting required through the 
end of the study 
• Within 10 calendar days of first 
becoming aware of the event or 
as per local/regional 
regulations.  
• Reporting required through the 
end of the study 
Provide all relevant 
source documentation 
(de-identified/ 
pseudonymized) for 
reported event. 
• Upon request of sponsor 
• When documentation is 
available. 
• Upon request of sponsor 
Serious Adverse Device 
Effects 
 
Complete AE eCRF 
page with all available 
new and updated 
information. 
• Within 3 calendar days of first 
becoming aware of the event or 
as per local/regional 
regulations.  
• Within 3 calendar days of first 
becoming aware of the event or 
as per local/regional 
regulations.  

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Table 16-3: Investigator Reporting Requirements 
 
Event Classification 
Communication 
Method  
Communication Timeline pre-
market studies 
(21 CFR Part 812, MDCG 
2020-10/1) 
Communication Timeline post-
market studies 
(EU MDR 2017/745, MDCG 
2020-10/1 
MEDDEV 2.12/1:  
GUIDELINES ON A MEDICAL 
DEVICE VIGILANCE SYSTEM) 
• Reporting required through the 
end of the study 
• Reporting required through the 
end of the study 
Provide all relevant 
source documentation 
(de-identified/ 
pseudonymized) for 
reported event, as 
requested by sponsor.  
• When documentation is 
available 
• When documentation is 
available 
• Upon request of sponsor 
• Upon request of sponsor.  
Device Deficiencies 
(including but not 
limited to, malfunctions 
use errors, and 
inadequacy in 
information supplied by 
the manufacturer, 
including labelling) 
Note: Any Study 
Device Deficiency that 
might have led to a 
serious adverse event if 
appropriate action had 
not been taken, 
intervention had not 
occurred, circumstances 
had been less fortunate 
is considered a 
reportable event. 
Complete eCRF page 
with all available new 
and updated 
information.  
• Within 3 calendar days of first 
becoming aware of the event.  
• Reporting required through the 
end of the study 
• Within 3 calendar days of first 
becoming aware of the event. 
Reporting required through the 
end of the study 
Provide all relevant 
source documentation 
(de-identified/ 
pseudonymized) for 
reported event. 
• At request of sponsor  
• Upon request of sponsor 
Adverse Event 
including Adverse 
Device Effects 
Complete AE eCRF 
page, which contains 
such information as 
date of AE, treatment of 
AE resolution, 
assessment of 
seriousness and 
relationship to the 
device.  
• In a timely manner (e.g. 
recommend within 10 business 
days) after becoming aware of 
the information 
• Reporting required through end 
of study  
• At sponsor request 
• Adverse Device Effects (or 
other key events of interest, 
e.g., Heart Failure): In a timely 
manner but not later than 30 
business days after becoming 
aware of the information 
• Adverse Events: In a timely 
manner but recommend within 
30 business days after 
becoming aware of the 
information 
• Reporting required through end 
of study  
• Upon request of sponsor 
Provide all relevant 
source documentation 
(de-identified/ 
pseudonymized) for 
reported event.  

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Table 16-3: Investigator Reporting Requirements 
 
Event Classification 
Communication 
Method  
Communication Timeline pre-
market studies 
(21 CFR Part 812, MDCG 
2020-10/1) 
Communication Timeline post-
market studies 
(EU MDR 2017/745, MDCG 
2020-10/1 
MEDDEV 2.12/1:  
GUIDELINES ON A MEDICAL 
DEVICE VIGILANCE SYSTEM) 
 
* Please note that pre-market studies are clinical studies with investigational devices or with medical devices that bear the 
regulatory approval and are not being used for the same approved indications. 
 
16.5. Device Deficiencies 
Device deficiencies for the Devices under study (i.e. the study device) will be documented 
and reported to BSC. If possible, the device(s) under study should be returned to BSC for 
analysis. Instructions for returning the study device(s) will be provided in site initiation visit 
slides. Device deficiencies should also be documented in the subject’s source records. 
Device deficiencies are not adverse events. However, an adverse event that results from a 
device deficiency would be recorded as an adverse event on the appropriate eCRF. 
16.6. Reporting to Regulatory Authorities / IRBs / ECs / REBs/ Investigators 
BSC is responsible for reporting adverse event information to all participating Principal 
Investigators, IRBs/ECs/REBs and regulatory authorities, as applicable.  
The Principal Investigator is responsible for informing the IRB/EC/REB, and regulatory 
authorities of UADEs and SAEs as required by local/regional regulations. 
17. Informed Consent 
Subject participation in this clinical study is voluntary. Informed Consent is required from 
each subject or his/her legally authorized representative. The Investigator is responsible for 
ensuring that Informed Consent is obtained prior to the use of any study devices, study-
required procedures and/or testing, or data collection.  
The obtaining and documentation of Informed Consent must be in accordance with the 
principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and 
local Ethics Committee and/or Regulatory authority, as applicable. The ICF must be accepted 
by BSC or its delegate (e.g. CRO) and approved by the site’s IRB/EC/REB, or central IRB, if 
applicable. 

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Boston Scientific will provide a study-specific template of the ICF to investigators 
participating in this study. The ICF template may be modified to meet the requirements of the 
investigative site’s IRB/EC/REB. Any modification requires acceptance from BSC prior to 
use of the form. The ICF must be in a language understandable to the subject and if needed, 
BSC will assist the site in obtaining a written consent translation. Translated consent forms 
must also have IRB/EC/REB approval prior to their use. Privacy language shall be included 
in the body of the form or as a separate form as applicable.   
The process of obtaining Informed Consent shall at a minimum include the following steps, 
as well as any other steps required by applicable laws, rules, regulations and guidelines: 
• be conducted by the Principal Investigator or designee authorized to conduct the process,  
• include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
• avoid any coercion of or undue influence of subjects to participate, 
• not waive or appear to waive subject’s legal rights, 
• use native language that is non-technical and understandable to the subject or his/her 
legal representative, 
• provide ample time for the subject to consider participation and ask questions if 
necessary, 
• ensure important new information is provided to new and existing subjects throughout the 
clinical study.  
The ICF shall always be signed and personally dated by the subject or legal representative 
competent to sign the ICF under the applicable laws, rules, regulations and guidelines and by 
the investigator and/or an authorized designee responsible for conducting the informed 
consent process. If a legal representative signs, the subject shall be asked to provide informed 
consent for continued participation as soon as his/her medical condition allows. The original 
signed ICF will be retained by the site and a copy of the signed and dated document and any 
other written information must be given to the person signing the form.  
Failure to obtain subject consent will be reported by BSC to the applicable regulatory 
authority according to their requirements (e.g., FDA requirement is within 5 working days of 
learning of such an event). Any violations of the informed consent process must be reported 
as deviations to the sponsor and local regulatory authorities (e.g. IRB/EC/REB), as 
appropriate. 
If new information becomes available that can significantly affect a subject's future health 
and medical care, that information shall be provided to the affected subject(s) in written form 
via a revised ICF or, in some situations, enrolled subjects may be requested to sign and date 
an addendum to the ICF. In addition to new significant information during the course of a 
study, other situations may necessitate revision of the ICF, such as if there are amendments 
to the applicable laws, protocol, a change in Principal Investigator, administrative changes, or 
following annual review by the IRB/EC/REB. The new version of the ICF must be approved 
by the IRB/EC/REB. Acceptance by Boston Scientific is required if changes to the revised 

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ICF are requested by the site’s IRB/EC/REB. The IRB/EC/REB will determine the subject 
population to be re-consented. 
18. Committees 
18.1. Safety Monitoring Process 
The BSC personnel from the Medical Safety and Safety Trial Operation group review safety 
data as it is reported by the sites throughout the duration of the study. During scheduled 
monitoring activities, clinical research monitors further support this review through their 
review of source documents and other data information. The BSC Medical Safety and Safety 
Trial Operations team include health care providers with expertise and with the necessary 
therapeutic and subject matter expertise to evaluate and classify the events into the categories 
outlined above. 
 
There will be no other committees (e.g., Clinical Events Committee, Data Monitoring 
Committee, Independent Data Reviewer, Morbidity and Mortality Events Committee, etc.) 
used in this study. 
19. Suspension or Termination 
19.1 Premature Termination of the Study 
Boston Scientific reserves the right to terminate the study at any stage but intends to exercise 
this right only for valid scientific or business reasons and reasons related to protection of 
subjects.  Investigators, associated IRBs/ECs/REBs, and regulatory authorities, as applicable, 
will be notified in writing in the event of study termination. 
19.1.1 Criteria for Premature Termination of the Study 
Possible reasons for premature study termination include, but are not limited to, the 
following: 
• Suspicion of an unacceptable risk, including serious health threat. In this case, the 
sponsor shall suspend the clinical investigation while the risk is assessed. The sponsor 
shall terminate the clinical investigation if an unacceptable risk which cannot be 
controlled is confirmed. 
• Instructions by the IRB/EC/REB or regulatory authorities to suspend or terminate the 
clinical investigation. 
• An enrollment rate far below expectation that prejudices the conclusion of the study.  
• A decision on the part of Boston Scientific to suspend or discontinue development/ 
marketing of the device. 

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19.2 Termination of Study Participation by the Investigator or Withdrawal of IRB/ EC 
/REB Approval 
Any investigator or associated IRB/EC/REB or regulatory authority may discontinue 
participation in the study or withdraw approval of the study, respectively, with suitable 
written notice to Boston Scientific. Investigators, associated IRBs/ECs/REBs, and regulatory 
authorities, as applicable, will be notified in writing in the event of these occurrences. 
19.3. Requirements for Documentation and Subject Follow-up 
In the event of premature study termination a written statement as to why the premature 
termination has occurred will be provided to all participating sites by Boston Scientific. The 
IRB/EC/REB and regulatory authorities, as applicable, will be notified. Detailed information 
on how enrolled subjects will be managed thereafter will be provided.  
In the event an IRB/EC/REB terminates participation in the study, participating investigators, 
associated IRBs/ECs/REBs, and regulatory authorities, as applicable, will be notified in 
writing. Detailed information on how enrolled subjects will be managed thereafter will be 
provided by Boston Scientific. 
In the event a Principal Investigator terminates participation in the study, study responsibility 
will be transferred to another investigator, if possible. In the event there are no opportunities 
to transfer Principal Investigator responsibility; detailed information on how enrolled 
subjects will be managed thereafter will be provided by Boston Scientific. 
The Principal Investigator or his/her designee must return all study-related documents and  
study product to Boston Scientific, unless this action would jeopardize the rights, safety, or 
welfare of the subjects. 
19.4 Criteria for Suspending/Terminating a Study Site 
Boston Scientific reserves the right to stop the inclusion of subjects at a study site at any time 
after the study initiation visit if no subjects have been enrolled for a period beyond 12 months 
after site initiation, or if the site has multiple or severe protocol violations/noncompliance 
without justification and/or fails to follow remedial actions. 
In the event of termination of site participation, all study devices and testing equipment, as 
applicable, will be returned to BSC unless this action would jeopardize the rights, safety or 
well-being of the subjects. The IRB/EC/REB and regulatory authorities, as applicable, will 
be notified. Study participants will be contacted, as applicable, and be informed of changes to 
study visit schedule. 
20. Study Registration and Results 
20.1. Study Registration 
To comply with applicable laws and regulations, the study will be registered on a publicly 
accessible database. 

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20.2. Clinical Investigation Report 
Study results will be made available in accordance with the legal requirements and the 
recognized ethical principles, in accordance with the Boston Scientific Policy. A Clinical 
Investigation Report will be made available to all investigators, IRB/EC/REB and regulatory 
authorities, as applicable in accordance with the Boston Scientific Policy and local 
requirements.  As applicable an abbreviated Clinical Investigation Report will be made 
available on a publicly accessible database. 
20.3. Publication Policy 
BSC requires disclosure of its involvement as a sponsor or financial supporter in any 
publication or presentation relating to a BSC study or its results. BSC may submit study 
results for publication (regardless of study outcome) following the conclusion or termination 
of the study. Boston Scientific adheres to the Contributorship Criteria set forth in the 
Uniform Requirements of the International Committee of Medical Journal Editors (ICMJE; 
http://www.icmje.org). In order to ensure the public disclosure of study results in a timely 
manner, while maintaining an unbiased presentation of study outcomes, BSC personnel may 
assist authors and investigators in publication preparation provided the following guidelines 
are followed:  
• All authorship and contributorship requirements as described above must be followed. 
• BSC involvement in the publication preparation and the BSC Publication Policy should 
be discussed with the Coordinating Principal Investigator(s) and/or Executive/Steering 
Committee at the onset of the project. 
• The First and Senior authors are the primary drivers of decisions regarding publication 
content, review, approval, and submission.  
The data, analytic methods, and study materials for this clinical trial may be made available 
to other researchers in accordance with the Boston Scientific Data Sharing Policy 
(https://www.bostonscientific.com/).  
21. Reimbursement and Compensation for Subjects 
21.1. Compensation for Subject’s Health Injury 
Boston Scientific will purchase an insurance policy to cover the cost of potential health 
injury for study subjects, if required by applicable law.  
22. Bibliography 
1. Baron TH, Kozarek RA, Carr-Locke DL. ERCP. 3rd ed. Philadelphia: Elsevier; 
c2019. Chapter 5, Duodenoscope Reprocessing; p. 44-48. 

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2. Funk S.E., Reaven N.L. High-level endoscope disinfection processes in emerging 
economies: financial impact of manual process versus automated endoscope 
reprocessing. Journal of Hospital Infection 2014, 86, 250-254. 
3. Epstein L, Hunter JC, Arwady MA, Tsai V, Stein L, Gribogiannis M, et al. New 
Delhi metallo-β-lactamase-producing carbapenem-resistant Escherichia coli 
associated with exposure to duodenoscopes. JAMA. 2014;312:1447–1455. 
4. Verfaillie CJ, Bruno MJ, Voor in ’t Holt AF, Buijs JG, Poley JW, Loeve AJ, et al. 
Withdrawal of a novel-design duodenoscope ends outbreak of a VIM-2-producing 
Pseudomonas aeruginosa. Endoscopy. 2015;47:493–502. 
5. Wendorf KA, Kay M, Baliga C, Weissman SJ, Gluck M, Verma P, et al. Endoscopic 
retrograde cholangiopancreatography-associated AmpC Escherichia coli outbreak. 
Infect Control Hosp Epidemiol. 2015;36:634–642. 
6. Rauwers AW, Voor in ‘t holt AF, Buijs JG, de Groot W, Hansen BE, Bruno MJ, Vos 
MC. High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide 
study. GUT. 2018;0,1-9. 
7. Alrabaa SF, Nguyen P, Sanderson R, Baluch A, Sandin RL, Kelker D, et al. Early 
identification and control of carbapenemase-producing Klebsiella pneumoniae, 
originating from contaminated endoscopic equipment. Am J Infect Control. 
2013;41:562–564. 
8. Murray P. Preventable tragedies: superbugs and how ineffective monitoring of 
medical device safety fails patients. Health, Education, Labor, and Pensions 
Committee, US Senate: Washington, DC; 2016. 
9. Koleva J, Peters FT, van de Mei HC, Degener JE. Transmission of infection by 
flexible gastrointestinal endoscopy and bronchoscopy. Clin Microbiol Rev. 
2013;26(2):231-254. 
10. Rutala WA, Weber DJ. Gastrointestinal Endoscopes: A Need to Shift From 
Disinfection to Sterilization? JAMA. 2014;312(14):1405–1406. 
doi:10.1001/jama.2014.12559. 
11. FDA. FDA warns duodenoscope manufacturers about failure to comply with required 
postmarket surveillance studies to assess contamination risk. 2018 Mar 9. Available 
from 
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm600388.htm 
12. FDA. FDA Continues to Remind Facilities of the Importance of Following 
Duodenoscope Reprocessing Instructions: FDA Safety Communication. 2019 Apr 12. 
Available from 
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm600388.htm 
13. Kohli DR, Grys TE, Pannala R. Eliminating Duodenoscope-Associated Transmission 
of Carbapenem-Resistant Enterobacteriaceae (CRE): In Search of an Optimal 
Strategy. Dig Dis Sci. 2017;62(11):2961-2963. 

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23. Abbreviations and Definitions  
23.1. Abbreviations 
Abbreviations are shown in Table 23-1.   
Table 23-1: Abbreviations 
Abbreviation/Acronym 
Term 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
BSC 
Boston Scientific Corporation 
CA 
Competent Authority 
CRE 
Carbapenem-resistant Enterobacteriaceae 
CRF 
Case Report Form 
CRO  
Contract Research Organization 
EC 
Ethics Committee 
ERCP 
Endoscopic Retrograde Cholangio-Pancreatography 
EDC 
Electronic Data Capture 
FDA 
U.S. Food and Drug Administration 
GCP 
Good Clinical Practice 
GI 
Gastrointestinal 
HCP 
Health Care Personnel 
HLD 
High Level Disinfection 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IRB 
Institutional Review Board 
ITT 
Intent-to-Treat 
REB 
Research Ethics Board 
SADE 
Serious Adverse Device Effect 
SAE 
Serious Adverse Event 
UADE 
Unanticipated Adverse Device Effect 
USADE 
Unanticipated Serious Adverse Device Effect