Outpatient Colonoscopy: Demonstrating Effective Salvage of Inadequate Colonoscopies Utilizing the Pure-Vu EVS System
Phase: NA
Conditions: Colorectal Screening
Sponsor: Motus GI Medical Technologies Ltd

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 1 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
 
Clinical Investigational Plan (CIP) INFORMATION 
Title: 
Outpatient Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS System  
CIP Number: 
CL00052 
Version Date: 
October 31, 2022 
Amendment 
2.0 
Sponsor: 
Motus GI Medical Technologies LTD. 
1301 E. Broward Blvd. 301 
Fort Lauderdale, FL 33301 
 
This document is property of MOTUS GI Medical Technologies LTD, its contents are 
CONFIDENTIAL and shall not be disclosed, disseminated, copied or used, without a written 
permission. 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 2 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
Summary of Changes to CIP 
Version 
Section 
Description of Change 
Reason for Change 
Original 
NA 
NA- Original document 
NA 
Amendment 
1 
Throughout 
protocol 
Updated statistical strategy 
for sample size; additional 
exclusion criteria added. 
Safety endpoint changed to a 
comparison to reported 
standards. Formatting and 
grammar updates.  
Updated Statistical 
Calculations, Clarification for 
all sections 
Amendment 
2 
Statistical 
Updated sample size and 
clarified statistical definitions. 
Added bulleted expected 
risks to align with consent 
language.  Updated exclusion 
criteria and aligned post 
procedure follow up visit up 
to 14 days. 
Updated sample size; Updates 
based on feedback received 
during the investigator 
meeting  
 
 
 
 
 
 
 
 
 
 
 
 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 3 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
 
 
 
 
 
Investigator Signature Page 
Title: 
Outpatient Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS System 
CIP Number: 
CL00052 
Version Date: 
October 31, 2022 
Amendment 
2.0 
 
I, the undersigned, have read and understood the protocol specified above and agree on its content. 
I agree to perform and conduct the study as described in the protocol and in accordance with the 
relevant laws/regulations and standards. 
 
 
________________________    ____________________________    ______________________ 
Name  
 
 
 
Signature 
 
 
 
Date 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 4 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
 
 
 
 
Table of Contents 
 
1) 
Protocol Synopsis ......................................................................................................................... 7 
2) 
Acronyms and Definitions .......................................................................................................... 11 
3) 
Introduction ................................................................................................................................ 12 
4) 
Background ................................................................................................................................ 12 
5) 
Study Device .............................................................................................................................. 14 
6) 
General Description .................................................................................................................... 14 
7) 
Pure-Vu Workstation .................................................................................................................. 16 
8) 
Pure-Vu Disposable Kit .............................................................................................................. 16 
9) 
Pure-Vu Prior Investigations ...................................................................................................... 17 
10) 
Risk to Benefit Ratio .................................................................................................................. 20 
11) 
Anticipated Risks Associated with the Study Device ................................................................ 20 
12) 
Potential Benefits to the Subject ................................................................................................ 21 
13) 
Study Purpose ............................................................................................................................. 21 
14) 
Primary Objective ....................................................................................................................... 21 
15) 
Secondary Objectives ................................................................................................................. 21 
16) 
Primary Endpoint ....................................................................................................................... 21 
17) 
Secondary Endpoints .................................................................................................................. 22 
18) 
Tertiary Endpoints ...................................................................................................................... 22 
19) 
Primary Safety Endpoint ............................................................................................................ 22 
20) 
Study Design .............................................................................................................................. 23 
21) 
Selection and Enrollment ........................................................................................................... 24 
22) 
Inclusion and Exclusion Criteria ................................................................................................ 25 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 5 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
23) 
Withdrawal and Screen Failures ................................................................................................. 25 
24) 
Selection of Investigators and Training ...................................................................................... 26 
25) 
Study Procedures ........................................................................................................................ 26 
26) 
Screening and Informed Consent ............................................................................................... 26 
27) 
Day of Procedure (D0) ............................................................................................................... 27 
28) 
Pre-Procedure ............................................................................................................................. 27 
29) 
Colonoscopy Procedure .............................................................................................................. 27 
30) 
Post Procedure Follow Up .......................................................................................................... 28 
31) 
Statistical Analysis ..................................................................................................................... 29 
32) 
Sample Size Determination ........................................................................................................ 29 
33) 
Description of Statistical Methods ............................................................................................. 29 
34) 
Safety Population ....................................................................................................................... 30 
35) 
Intent-to-Treat (ITT) Population ................................................................................................ 30 
36) 
Per Protocol (PP) Population ...................................................................................................... 30 
37) 
Inadequate Bowel Preparation (IBP) Population ....................................................................... 30 
38) 
Primary Endpoint Analysis ........................................................................................................ 30 
39) 
Secondary Endpoint Analysis .................................................................................................... 31 
40) 
Tertiary Endpoint Analysis ........................................................................................................ 31 
41) 
Safety Endpoint Analysis ........................................................................................................... 31 
42) 
Adverse Events and Classifications ........................................................................................... 31 
43) 
Adverse Event (AE) ................................................................................................................... 31 
44) 
Serious Adverse Event (SAE) .................................................................................................... 31 
45) 
Adverse Device Effect (ADE) .................................................................................................... 32 
46) 
Serious Adverse Device Effect (SADE) .................................................................................... 32 
47) 
Unanticipated Adverse Device Effect (UADE) ......................................................................... 33 
48) 
Unanticipated Serious Adverse Device Effect (USADE) .......................................................... 33 
49) 
Classification of Event Severity, Relationship and Outcomes ................................................... 33 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 6 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
50) 
Adverse Event Severity Classification ....................................................................................... 33 
51) 
Adverse Event Relationship Classification ................................................................................ 33 
52) 
Adverse Event Outcome Classification ...................................................................................... 34 
53) 
Device Deficiencies .................................................................................................................... 34 
54) 
Adverse Event Recording and Reporting ................................................................................... 34 
55) 
Reporting Responsibilities ......................................................................................................... 35 
56) 
Ethics and Compliance ............................................................................................................... 35 
57) 
Statement of Compliance ........................................................................................................... 35 
58) 
Protocol Compliance .................................................................................................................. 36 
59) 
Institutional Review Board (IRB) .............................................................................................. 36 
60) 
Subject Informed Consent .......................................................................................................... 36 
61) 
Insurance .................................................................................................................................... 37 
62) 
Confidentiality ............................................................................................................................ 37 
63) 
Use of Data and Publications ..................................................................................................... 37 
64) 
Study Monitoring ....................................................................................................................... 38 
65) 
Data Collection and Processing .................................................................................................. 39 
66) 
Study Supplies and Device Accountability ................................................................................ 40 
67) 
Packaging ................................................................................................................................... 40 
68) 
Labeling ...................................................................................................................................... 40 
69) 
Inventory Control ....................................................................................................................... 40 
70) 
General Information ................................................................................................................... 41 
71) 
Study Contact Information ......................................................................................................... 41 
72) 
Retention of Records .................................................................................................................. 41 
73) 
Study Completion and Termination of Study ............................................................................. 41 
74) 
References .................................................................................................................................. 42 
75) 
Appendices ................................................................................................................................. 43 
 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 7 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
 
 
 
 
1) Protocol Synopsis 
 
Study Summary 
Study Purpose 
The aim of this study is to demonstrate that the use of the Pure-Vu EVS 
System can salvage inadequately prepared optical colonoscopies (OCs) 
to adequate OCs.   
 
Inadequate OCs defined as such if any of the following are met: 
▪ 
Boston Bowel Preparation Score (BBPS) < 6  
(Adequacy is defined as BBPS of 2 or greater in each 
segment) 
▪ 
Inability to identify > 5mm polyps 
Primary Objective 
The primary objective of this study is to demonstrate the reduction of 
inadequate colonoscopies when Pure-Vu EVS System is used to salvage 
inadequately prepped colons as defined by the multi-society guidelines 
(USMSTF). 
Secondary Objective 
The secondary objective of this study is to assess the impact of the 
Pure-Vu System on patient outcomes. 
Study Procedures 
Protocol Number 
CL00052 
Protocol Title 
Outpatient Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS System 
Study Sponsor  
Motus GI Medical Technologies LTD. 
1301 E. Broward Blvd. 301 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 8 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
Fort Lauderdale, FL 33316 
Study Type 
Multicenter, Prospective, Consecutive Series, Pragmatic Clinical Trial  
Study Device 
Pure-Vu EVS System  
Study Phase 
Post-market 
510 (k) Number 
K220007 Class II 
Study Location 
United States  
Study Duration 
Study period will last approximately 12 months  
Planned Follow-Up 
Follow-up call will be conducted within 14 business days after the 
procedure  
Subject Population 
Patients who are eligible and are scheduled for an outpatient 
colonoscopy procedure 
Sample Size 
Subjects will be enrolled until 115 inadequate bowel prep cases via 
SOC are accrued and subsequently treated with Pure-Vu. 115 IBP 
cases provides 90% power and with an expected 12% inadequate 
bowel prep rate and accounting for 10% attrition, approximately 
1,067 subjects will need to be enrolled to achieve 115 inadequate 
preps required Pure-Vu. A minimum of 50% of enrollees with 
inadequate bowel prep must utilize Medicare or Medicaid as their 
insurance provider.  
 
The following assumptions were considered for sample size 
calculation: 
• 
Performance goal for 30% reduction 
• 
90% Power and two-sided α= 0.05 
• 
True reduction in IBP vs. SOC = 50% 
• 
~10% attrition rate 
Planned # of Sites 
Up to 15 clinical sites 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 9 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
Primary Endpoints 
Rate of incomplete colonoscopies due to inadequate preparation 
salvaged to adequate colonoscopies with the use of the Pure-Vu EVS 
System.   
Inadequate OCs defined as such if any of the following are met: 
▪ 
BBPS < 6  
(Adequacy is defined as BBPS of 2 or greater in each 
segment) 
▪ 
Inability to identify > 5mm polyps  
The estimated rate of salvaged preparations will be calculated and 
presented with exact two-sided 95% confidence interval:  Number of 
preps inadequate with SOC and adequate after Pure-VU EVS System / 
Number of preps inadequate with SOC. 
 
The lower bound will be compared to a 30% performance goal. 
Secondary Endpoints The following secondary endpoints will be assessed: 
1. Number of polyps and adenomas: type, location, size, pathology, 
and morphology, as well as: 
● 
Polyp Detection Rate (PDR) 
● 
Polyp Miss Rate (PMR) 
● 
Adenoma Detection Rate (ADR) 
● 
Adenoma Miss Rate (AMR) 
● 
Adenoma Per Colonoscopy (APC) 
● 
Adenomas Per Positive Patient (APP) 
● 
Sessile Serrated Adenoma Detection Rate 
2. BBPS before and after Pure-Vu EVS use 
3. Other Procedural Outcomes (including but not limited to): 
● Sedation type 
● Procedure time: time to cecum and withdrawal time 
● Intraprocedural tools 
4. Cecum Intubation Rate  

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 10 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
5. Compliance to published interval guidelines for surveillance or 
repeat screening (Proscribed intervals per USMSTF) 
Tertiary Endpoints 
1. Clinician Satisfaction 
2. Economic Impact 
Primary Safety 
Endpoint 
Comparison of SAE rates between Pure-Vu subjects and the published 
serious complication rate of standard colonoscopy procedures (2.8%)12 
Secondary Safety 
Endpoint 
All adverse events that are definitely and/or potentially attributed 
to Pure-Vu will be summarized using descriptive statistics.  
Eligibility Criteria 
Inclusion Criteria 
1. Eligible adults aged between 40-80 
2. Elective outpatient colonoscopy by participating gastroenterologist 
 
Exclusion Criteria 
1. Not competent to consent 
2. Known or suspected bleeding disorders such as, but not limited to 
hemophilia and von Willebrand disease 
3. History of colonic resection 
4. Prior incomplete colonoscopy due to patient anatomy   
5. Diverticulitis 
6. Active Inflammatory bowel disease (Crohn’s, Ulcerative Colitis, or 
Indeterminate) 
7. Known or suspected colon stricture/fistula 
8. Hereditary Colorectal Cancer Syndrome 
9. Subject is pregnant or suspected pregnant 
Interim analyses 
There are no interim analyses planned.   
 
 
 
 
 
 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 11 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
 
2) Acronyms and Definitions 
ADE 
Adverse Device Effect 
AE 
Adverse Event 
BBPS 
Boston Bowel Preparation Scale 
CIP 
Clinical Investigation Plan 
CMP 
Clinical Monitoring Plan  
CRC 
Colorectal Cancer 
CRF 
Case Report Form 
CRO 
Clinical Research Organization 
DMP 
Data Management Plan  
eCRF 
Electronic Case Report Form  
EDC 
Electronic Data Capture 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
GI 
Gastrointestinal 
IBP 
Inadequate Bowel Preparation  
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonization 
IFU 
Instruction For Use 
IRB 
Institutional Review Board 
ISO 
International Organization for Standardization 
OC 
Optical Colonoscopy 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 12 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
MAC 
Monitored Anesthesia Care 
SAE 
Serious Adverse Event 
SADE 
Serious Adverse Device Effect  
USADE 
Unanticipated Serious Adverse Device Effect  
USMSTF 
United States Multi-Society Task Force  
WS 
Workstation 
 
3) Introduction 
This document is a protocol for human research study. This study will be conducted in accordance with 
local government regulations, and applicable international standard of Good Clinical Practice, and 
institutional research policies and procedures. 
4) Background  
As of 2019, it is estimated that more than sixteen million colonoscopies were performed annually in 
the United States (1). This is not surprising given that colonoscopy is the gold standard in visualizing 
the lower gastrointestinal (GI) tract. Patients receive a colonoscopy for a variety of reasons including 
lower GI bleeds, chronic diarrhea and abdominal pain, iron deficiency anemia, hematochezia, and most 
importantly, for colorectal cancer (CRC) screening and surveillance, which currently accounts for 60-
70% of colonoscopy indications (2).  While it is true that other minimally or noninvasive technologies 
exist, such as blood-immunological test, CT colonography and capsule endoscopy, colonoscopy 
remains the current gold standard as it allows a clinician to view the entire lower GI tract, detect and 
diagnose the cause of symptoms, screen for precursor colorectal neoplasia, and in some instances, 
provide interventions in real time.   
The first colonoscopy procedures were conducted in 1969 and by the late 1970’s it was cemented as a 
standard procedure for most gastroenterologists (3). Between 1969 and today, several advancements 
have been made in the colonoscopy space including improved endoscopes, the move to video 
endoscopes, streamlined bowel preparation regimens, updates to intraprocedural tools, and by 2020, 
the first artificial intelligence aided screening colonoscopies were occurring in Europe. While 
advancements in the GI space have been made continually since the first procedures, it wasn’t until 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 13 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
2006, 35+ years after the first colonoscopy, that standardized quality metrics were adopted and 
tracked in clinical practice. Even with these innovations and guideline creations, certain aspects of 
colonoscopy still present significant hurdles to both the patients and treating clinicians. One such 
barrier is that of bowel preparation.  
Each patient presenting to colonoscopy is required to prepare their bowel to ensure that the bowel is 
empty of any contaminants and that the mucosa of the large intestine is properly exposed. For an 
outpatient colonoscopy (and the standard of care for this trial), a typical preparation regimen includes 
24-hour clear liquid diet in combination with a prescribed or over-the-counter purgative. Bowel 
purgative can include anything from over-the-counter laxatives to a 2L-4L liquid pharmacologic agent. 
Even though there has been some innovation around bowel preparation, such as split dose regimens 
and low volume prep agents, bowel preparation remains one of the largest impediments to getting 
patients to a screening or surveillance colonoscopy. Contributing factors are in part due to the volume 
of fluid ingested, the intended effects of preparation, the need to take off work for multiple days, the 
out-of-pocket cost and the side effects related to the preparation process. In instances where a patient 
is fully compliant with the bowel preparation regimen, they may still present for their procedure 
inadequately prepped.  Several risk factors associated with inadequate bowel preparation (IBP) include 
older age, medications such as opioids and antidepressants, comorbidities like diabetes and obesity, 
socio-economic status, and while these factors have been identified, there is no validated algorithm 
that can predict whether a patient will present with IBP (4). It should be noted that once a patient 
presents with an inadequately prepped colon at the initial procedure, 24-36% of those patients will 
have a recurrence of IBP at subsequent procedures (5). 
The United States Multi-Society Task Force (USMSTF) defines adequate bowel preparation by the 
clinician’s ability to see polyps larger than 5mm which is a key metric in obtaining a high-quality 
colonoscopy (6). In fact, guidelines suggests that colonoscopies with inadequate preparation be 
repeated within one year, however in real world practice, sub-optimal bowel preparation that doesn’t 
quite meet the threshold of “inadequate” is associated with more frequent deviations (shortened 
interval) from colorectal cancer (CRC) screening and surveillance guidelines. 
Increased colonoscopy frequency resulting from inadequate preparation raises a number of safety and 
cost considerations for both patients as well as the overall healthcare system.  Even in situations where 
a patient presents with adequate bowel preparation for a repeat colonoscopy, there are significant 
financial considerations for patients, payers, and endoscopists. When factoring in the unpleasant 
preparation experience, potential side effects and financial burdens for patients, roughly 54% of 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 14 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
patients do not return for the recommended repeat colonoscopy (5).  For the healthcare system, after 
an incomplete examination, the reimbursement paradigm does not always guarantee that a repeat 
colonoscopy is 100% reimbursed. Due to this, average interval times for inadequately prepped colons 
often exceed the recommended guidelines.  
Per an article published by Calderwood et al in 2022, 25% of procedures are inadequately prepped, 
but even with this significant number, there has been limited evidence-based guidance on bowel 
preparation for patients who have had, or are at high risk for, inadequate preparation (7). As a result, 
numerous patients present on the day of colonoscopy with inadequate preparation and their treating 
clinicians are left with limited options to salvage poor preparation. In these instances, clinicians can 
prescribe additional oral purgative for later in the day colonoscopy or reschedule for a next day 
colonoscopy (thus prolonging the patient experience), attempt additional cleaning through the 
endoscope at time of procedure, or attempt a through-the scope enema. Regardless of salvage 
approach, there’s an inherent trickledown effect impacting scheduling, space, time, site of care 
resourcing, procedural time, and efficacy. Effective salvage of inadequate colon cleansing at the time 
of colonoscopy is a substantial unmet need and Motus GI has developed an intraprocedural cleansing 
tool to aid clinicians in obtaining optimal visualization. The Pure-Vu EVS System is an FDA cleared, intra-
procedure device that enables salvage of an inadequate preparation to one that is adequate, thus 
allowing the colonoscopy to continue as scheduled. This FDA-cleared device is placed over the 
colonoscope and utilizes a novel irrigation and suction technology.   
The goal of this consecutive series, pragmatic trial is to demonstrate that when the Pure-Vu EVS System 
is utilized to salvage poorly prepped colons, an overall reduction in the number of inadequate 
colonoscopies results, thus proving that the Pure-Vu EVS System is a viable solution in addressing the 
unmet need of inadequate preparations.  
5) Study Device 
6) General Description 
The Pure-Vu EVS System is an FDA 510(k) cleared cleansing device that enables colon cleansing during 
colonoscopy. The system attaches to a standard or slim colonoscope. The Oversleeve, which fits over 
the colonoscope and is connected to an external Workstation (WS), generates fluid and air to break up 
feces. The fecal matter & fluids are removed through the suction channels of the Oversleeve into an 
external waste container. 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 15 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
The Pure-Vu EVS System consists of the following main components:  
● Disposable device which includes an Oversleeve section with an integrated loading element and 
an Umbilical Section. The Oversleeve fits over the colonoscope. The Umbilical Section connects 
the Oversleeve to the external Workstation. 
● Workstation that is reusable and supplies an irrigation mixture of water or saline and gas and 
evacuates debris & fluids. 
Below is a drawing showing the various components of the system and where they connect to each 
other. 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 16 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
Figure 1: Pure-Vu Workstation – General design & components 
 
 
A detailed description of the system components, its principles of operation, dimensions and 
packaging is elaborated in the device’s Instruction for use (IFU). 
7) Pure-Vu Workstation 
The Workstation is designed to provide water or saline and gas for irrigation and suction to evacuate 
debris & fluids out of the body during the colonoscopy procedure. Care should be taken when 
removing the Workstation from the package so as not to damage any components. 
 
The WS has the following main functions: 
● Monitoring & Control Unit control the delivery of irrigation fluids and gas into the colon, 
and suction of fluids and debris from the colon. 
● Irrigation Bag/Bottle (saline or water) which is connected to the irrigation line. 
● Waste Containers/Bag for collecting the colon content & fluids that are suctioned from 
the colon through the suction lines. 
● Foot Pedal that activates the cleansing, suction and purging functions, and enables switching 
between cleansing modes used by the physician. 
8) Pure-Vu Disposable Kit 
The Pure-Vu® Disposable Kit is comprised of the Oversleeve, and the Umbilical Section. The Pure-Vu  
Oversleeve is a single use device, which fits over a standard or slim colonoscope with a length of  
1630mm – 1710mm and an outer diameter range of 11.7mm – 13.7mm. Once mounted over the 
colonoscope the effective outer diameter is less than 22mm. 
The Pure-Vu Oversleeve consists of a single irrigation channel and a single suction channel which is   
also used for in-line pressure sensing. The Oversleeve allows for proper connection to the colonoscope. 
Proximal to the scope grip is the in-line connector that enables attachment to the Umbilical Section.  
The Umbilical Section connects the Pure-Vu Oversleeve to the Workstation via the main connector. 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 17 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
9) Pure-Vu Prior Investigations 
Device/ Type of 
investigation/ 
Number of subjects 
Methodology 
Outcome and Conclusion 
Pure-Vu System 
during Product 
Development  
 
Preclinical study: 
35 Yorkshire cross 
swine (66% female) 
(8) 
Study subjects received a 
reduced bowel preparation to 
ensure an inadequate bowel 
preparation at baseline. Prior to 
the colonoscopy the Pure-Vu 
System was attached to the 
colonoscope and the baseline 
prep was assessed during 
insertion.  The Pure-Vu System 
cleansed the colon and the prep 
was then assessed post-Pure-Vu 
use. 
There were no adverse events, failed 
or prematurely terminated cases.  
Fourteen percent of the swine 
colons were adequately prepped at 
baseline (mean BBPS score 0.5 ± 0.7) 
and improved to 100% after use of 
the Pure-Vu system (p <0.001) 
(mean BBPS score 3.0 ± 0.0). 
The Pure-Vu System effectively 
cleaned inadequately prepped swine 
colons and found to be easy to use.   
Pure-Vu System: 
Generation 1 
 
Clinical Study: 
Outpatient 
feasibility study 
including 47 
outpatients enrolled 
at 3 clinical sites in 
Germany and the 
Netherlands (9) 
Study subjects indicated for 
screening, diagnostic or 
surveillance indication were 
enrolled and received minimal 
pre-procedure bowel 
preparation  
To ensure an inadequately 
prepped colon, subjects 
underwent a reduced 
preparation consisting of 
dietary restrictions (no dried 
fruit, seeds or nuts) starting 2 
days prior to the colonoscopy, 
and 18 to 24 hour clear liquid 
diet with a split dose of 20mg 
Bisacodyl.  The cleansing quality 
Study reported high rates of cecal 
intubation (97.9%), significant 
improvements in BBPS scores 
(Median score of 3.0 pre Pure-Vu to 
9.0 post Pure-Vu cleansing), 
proportion of subjects with 
adequate bowel cleansing (from 
19.1% to 97.9%; P<0.001), and 
physicians were satisfied with the 
ease of use of the device and it was 
well tolerated by the subjects.  No 
SAEs occurred during the study.  

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 18 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
was evaluated using BBPS 
before and after use of the 
Pure-Vu System. 
Pure-Vu System: 
Generation 1 
 
Clinical Study: 
Outpatient study 
including 50 
outpatients in 2 sites 
in Israel and Spain 
(10) 
Study subjects indicated for 
screening, diagnostic or 
surveillance indication were 
enrolled and received minimal 
pre-procedure bowel 
preparation  
To ensure an inadequately 
prepped colon, subjects 
underwent a reduced 
preparation consisting of 
dietary restrictions (no dried 
fruit, seeds or nuts) starting 2 
days prior to the colonoscopy, 
and 18 to 24 hour clear liquid 
diet with a split dose of 20mg 
Bisacodyl.  The cleansing quality 
was evaluated using BBPS 
before and after use of the 
Pure-Vu System. 
Study reported a cecum intubation 
rate of 98%.  Pure-Vu increased 
BBPS scores and increased the 
proportion of patients with an 
adequate cleansing level (31% of 
patients at baseline vs. 98% post 
Pure-Vu cleansing) and mean BBPS 
improvement of 5 to 9.   
Pure-Vu System: 
Generation 1 
 
Clinical Study:  
Inpatient Study 
including 95 
hospitalized subjects 
from 6 clinical sites 
in the US and 
Germany (11) 
This inpatient study included 95 
hospitalized patients. One 
patient was excluded due to the 
discovery of ulcerative colitis 
during the procedure which was 
a study exclusion.  A total of 94 
subjects (60% male) were 
enrolled from 6 clinical study 
sites.  The mean age of the 
subjects was 62.44 ± 13.47 
(range 28-88y) and the mean 
The proportion of patients with an 
adequate cleansing level (BBPS≥2 in 
each of the evaluated colon 
segments), increased significantly 
from 38% (32/84) at baseline to 96% 
(81/84) after use of Pure-Vu 
(P<0.001).  Increase of adequate 
preparation, defined as pre Pure-Vu 
BBPS scores of 2 or higher, was 
reported in 60%, 62%, and 47% to 
100%, 99%, and 97% of the left-side, 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 19 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
body mass index (BMI) was 
28.02 ± 6.62.   53 subjects had 
colonoscopy performed with a 
Standard Oversleeve and 41 
procedures used a Slim 
Oversleeve.  The clarity of the 
last bowel movement was 
available in 93 patients. Clear to 
moderately clear (grade 4-5) 
bowel movements were 
reported in 49% (46/93) of 
patients and dirty (grade 1-3) 
bowel movements were 
reported in 51% (47/93) of 
patients.         
 
transverse, and right segments, 
respectively after cleansing with 
Pure-Vu.  While subject assessment 
of poor clarity of last bowel 
movement was associated with 
lower BBPS score prior to cleansing 
with Pure-Vu, it was able to increase 
BBPS regardless of pre-procedure 
clarity score.    
Pure-Vu System cleansing improved 
BBPS scores regardless of pre-
procedure volume of bowel 
preparation consumed. 
Successful colonoscopy, defined as 
completed colonoscopy for the 
intended indication in the first 
attempt, was achieved in 98% 
(92/94) of subjects. In this study, 
12% (11/94) of procedures achieved 
a diagnosis for the intended 
indication prior to cecum intubation. 
Of the remaining 83 procedures, 
96% (81/83) of the colonoscopies 
reached and visualized the cecum 
during the study procedure and 86% 
(71/83) of these cases achieved 
cecum intubation using Pure-Vu.  In 
the 71 patients where the cecum 
was reached and successfully 
visualized with the Pure-Vu device, 
the total mean procedure time was 
27.43 minutes.   

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 20 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
One SAE was reported. A patient 
had a procedure-related, 1 cm rectal 
perforation which required surgical 
repair.  The patient was discharged 
48 hours post operatively and fully 
recovered with no additional clinical 
sequela. 3 mild adverse events were 
also reported including fever, 
abdominal pain, and a drop-in 
hemoglobin from 7.6 grams/dL pre-
procedure to 6.6 grams/dL.   All 
minor adverse events resolved, and 
the investigators recorded that the 
events were unlikely related to the 
Pure-Vu device. 
 
10) 
Risk to Benefit Ratio 
11) 
Anticipated Risks Associated with the Study Device 
The potential risks of having a colonoscopy may include death, colon perforation, infection, bleeding, 
swelling of the colon tissue, hemorrhoids and anal tearing, mucosal trauma, rectal/anal bleeding, 
abdominal pain, nausea, vomiting and bloating feeling; in rare instances, there might be changes in a 
subject’s heartbeat, low blood pressure or lack of oxygen as a result from the anesthesia. The risks 
associated with the specific use of Pure-Vu are expected to be similar to colonoscopies. There may be 
other risks that are unknown and cannot be foreseen. As with any colonoscopy procedure there are 
risks associated missed lesions, bowel perforation, pain, or bleeding. The risks associated with the 
specific use of Pure-Vu are expected to be comparable to standard colonoscopies. Also, risks have been 
mitigated to the furthest extent as required by regulatory bodies.  Based on low adverse event rates 
in past studies as well as risk mitigations per the applicable standards, the Pure-Vu System does not 
introduce significant additional risk to patients.  
 
 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 21 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
 
12) 
Potential Benefits to the Subject 
The potential benefits of the Pure-Vu System include improved visualization of the bowel mucosa that 
is obscured due to inadequate preparation or residual fecal matter.  Additionally, there is a potential 
reduced need for repeated colonoscopies due to insufficient colon preparation, these consequently 
may reduce pain, discomfort, risks, costs and lost productivity.   
13) 
Study Purpose 
The aim of this study is to demonstrate that the use of the Pure-Vu EVS System can salvage 
inadequately prepared optical colonoscopies (OCs) to adequate OCs.   
 
Inadequate OCs defined as such if any of the following are met: 
• Boston Bowel Preparation Score (BBPS) < 6  
(Adequacy is defined as BBPS of 2 or greater in each segment) 
• Inability to identify >5mm polyps 
14) 
Primary Objective 
The primary objective of this study is to demonstrate the reduction of inadequate colonoscopies 
when Pure-Vu EVS System is used to salvage inadequately prepped colons. 
15) 
Secondary Objectives 
The secondary objective of this study is to assess the impact of the Pure-Vu EVS System on patient 
outcomes. 
16) 
Primary Endpoint 
Rate of incomplete colonoscopies due to inadequate preparation salvaged to adequate 
colonoscopies with the use of the Pure-Vu EVS System.   
 
Inadequate OCs defined as such if any of the following are met: 
● BBPS < 6 (Adequacy is defined as BBPS of 2 or greater in each segment) 
● Inability to identify > 5mm polyps  

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 22 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
17) 
Secondary Endpoints 
The following secondary endpoints will be assessed: 
1. Number of polyps and adenomas: type, location, size, pathology, and morphology, as well as: 
• Polyp Detection Rate (PDR) 
• Polyp Miss Rate (PMR) 
• Adenoma Detection Rate (ADR) 
• Adenoma Miss Rate (AMR) 
• Adenoma Per Colonoscopy (APC) 
• Adenomas Per Positive Patient (APP) 
• Sessile Serrated Adenoma Detection Rate 
2. Boston Bowel Preparation Score (BBPS) before and after Pure-Vu EVS use 
3. Other Procedural Outcomes (including but not limited to): 
• Sedation type 
• Procedure time: time to cecum and withdrawal time including additional time 
necessary to perform Pure-Vu EVS, in cases where Pure-Vu is utilized.  
• Intraprocedural tools 
4. Cecum Intubation Rate  
5. Compliance to published interval guidelines for surveillance or repeat screening       
(Prescribed intervals per USMSTF)     
18) 
Tertiary Endpoints 
• Clinician Satisfaction:  Each clinician will complete a questionnaire for each completed 
Pure-Vu EVS procedure. 
• Economic Impact:  An assessment of the economic impact will be performed as part of 
the overall study analysis.  Impact will be calculated by utilizing both data generated 
as part of the study (such as polyp demographics, insurance type, and colonoscopy 
indication/type) and data published on the costs associated with outpatient 
colonoscopies and subsequent findings. 
19) 
Primary Safety Endpoint 
A comparison of SAE rates between Pure-Vu subjects and the published serious complication rate 
of standard colonoscopy procedures (2.8%)12. 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 23 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
20) 
Study Design 
This study is a multi-center prospective, consecutive series, pragmatic clinical trial, which reflects real 
world practices in the outpatient setting.  Patients are to be enrolled in a consecutive series manner, 
be indicated for outpatient colonoscopy and must have attempted or completed bowel preparation 
regimen. Academic institutions, private practice, outpatient centers and ambulatory surgical centers 
will be approached for participation in this study.   
Below is the diagram of the study design and patient flow.    
   

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 24 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
 
21) 
Selection and Enrollment 
A patient may be introduced to the study at the GI office when an outpatient colonoscopy is indicated.  
Once it’s determined that the patient is interested in participation and eligible for participation, he or 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 25 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
she will be consented for the study.  After conducting the consent process, obtaining informed consent, 
and answering questions, the subject will sign the sites' designated IRB approved informed consent 
form (ICF). This study also allows for an electronic consenting process.  Enrollment of approximately 
1,067 subjects is planned to achieve 115 patients with inadequate bowel prep.  
 
Subjects’ enrollment in the study will begin on the day of procedure and will last approximately 15 
days, including the procedure day, and one follow up call during the follow up period (within 14 days 
after the procedure).  Safety assessments will begin at the time of enrollment.   
22) 
Inclusion and Exclusion Criteria 
 
Inclusion Criteria 
1. Eligible adults aged between 40-80 
2. Elective outpatient colonoscopy by participating gastroenterologist 
 
Exclusion Criteria 
1. Not competent to consent 
2. 
Known or suspected bleeding disorders such as, but not limited to hemophilia and von 
Willebrand disease 
3. History of colonic resection 
4. Prior incomplete colonoscopy due to patient anatomy   
5. Diverticulitis 
6. Active inflammatory bowel disease (Crohn’s, Ulcerative Colitis, or Indeterminate) 
7. Known or suspected colon stricture/fistula 
8. Hereditary Colorectal Cancer Syndrome 
9. Subject is pregnant or suspected pregnant 
 
23) 
Withdrawal and Screen Failures 
Subjects may withdraw from the study at their own request or at the request of their legally 
acceptable representative. The investigator may withdraw a subject from the study at any time for 
the following reasons:  
• Severe side effects clearly related to the study device. 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 26 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
• Presence or appearance of exclusion criteria. 
• Appearance of accompanying diseases rendering further participation in the study 
impossible. 
• A significant protocol violation, as determined either by the sponsor or the investigator 
• Subject noncompliant with study procedures 
 
The sponsor must be informed in each withdrawal case.  For screen failures, and those satisfying 
inclusion/exclusion criteria but choosing not to participate in this study, Subject details will be 
documented in the screen failure log.  Subjects who have screen failed will be allowed to re-screen 
within 120 days of the initial screened date. 
24) 
Selection of Investigators and Training 
Board-certified gastroenterologists in accordance with US and hospital guidelines will be 
considered for participation as investigators in this study. Physicians in training (residents, fellows) 
and physician assistants may assist the Study Investigator in any aspect of the procedure as per 
standard practices at his/her institution but will not participate in performing the colonoscopy. 
 
Each Investigator participating in the clinical trial and the associated clinical study staff will receive 
training on the clinical protocol. This includes training on AE reporting, electronic case report form 
(eCRF) completion, and Good Clinical Practice (GCP), as well as the study device and system 
(including procedural use, device characteristics, shelf life and storage requirements, warnings, and 
precautions), if applicable. 
 
25) 
Study Procedures 
26) 
Screening and Informed Consent 
Once the patient is indicated for an outpatient colonoscopy, he or she will be approached to review 
the study and obtain consent on the informed consent form (ICF) prior to any study procedures.  
The purpose of the study and the benefits and risks of the procedures will be explained to the 
subject and the consent process will be documented accordingly in the medical records.  Subjects 
who agree to study participation must sign an IRB-approved ICF.  Subjects will be informed that 
their participation in this study is voluntary and they may refuse to participate or discontinue from 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 27 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
the study at any time. Subjects will be given the opportunity to ask the investigator questions so 
that they are informed about the research.  A copy of the signed informed consent must be 
provided to the subject and the informed consent process will be documented in source 
documents.  This study also allows for an electronic consenting process. 
 
If new information becomes available that may affect a subject’s decision to continue to take part 
in the study, this information will be discussed with the subject by the investigator. 
 
Screened subjects will be documented in the screening log until the subject presents for the day of 
procedure in which at that time the subject will receive a subject number.  
27) 
Day of Procedure (D0) 
On the day of elective outpatient colonoscopy, the subject’s eligibility to participate will be 
assessed again and if still eligible for the study, the subject will be assigned a study subject number 
in the format of 2-digit Site Number and 3-digit Subject Number (i.e. 01-001, 02-002). 
28) 
Pre-Procedure 
   If the subject is eligible to continue within the study, the following information will be collected:  
 
• Demographics (age, gender and race)  
• BMI 
• Relevant medical and surgical history 
• Colonoscope type  
• Indication for colonoscopy  
• Bowel preparation prescription details (type, dose, administration schedule, and diet)  
• Bowel preparation consumption details 
• Pre-procedure stool clarity grade  
• Relevant medications 
29) 
Colonoscopy Procedure 
The insertion during the colonoscopy procedure will be performed by the clinical study 
investigator(s), experienced in GI endoscopy according to the local standard of care.  The type of 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 28 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
sedation will not be dictated by the study but will be documented.  The colonoscope will be 
prepared and the procedure will proceed per the standard of care.  
 
During the procedure, the study endoscopist will be requested to document BBPS for each colon 
segment.  Once the endoscopist notices an inadequate segment, the endoscopist should attempt 
to cleanse per his/her standard of care practices with the goal to achieve a BBPS of 2 or higher for 
that segment. This should be repeated for each colonic segment.  If the study definition of 
inadequate is met in any segment, even after SOC cleansing, the endoscopist is required to take 
pictures of all accessed segment(s) including the inadequate segment(s).  The endoscopist will 
withdraw the colonoscope and all procedural outcomes and findings should be documented. Then 
the Pure-Vu Oversleeve will be placed onto the colonoscope, and the procedure will be performed 
utilizing the Pure-Vu System for cleansing. Photo-documentation of each segment will be required 
to show BBPS after Pure-Vu use. Once the procedure has been completed with Pure-Vu, procedural 
outcomes (inclusive of final adequacy determination after Pure-Vu use and findings will be 
documented again.  
 
If during the standard of care colonoscopy, the patient cannot proceed onto Pure-Vu and/or will 
be deemed an incomplete colonoscopy due to any reason other than inadequate prep, that subject 
will be withdrawn from the study. Such an instance might occur when a mass or stricture is found, 
or when an active inflammatory condition is detected but is it ultimately up to the Principal or Sub-
Investigator to make the determination during the procedure.  
 
 
30) 
Post Procedure Follow Up 
 
As part of the routine post-examination follow up, subjects will be transferred to the recovery room 
for observation per clinical site’s colonoscopy protocol and will continue his/her medical flow as 
per the standard of care. Follow-up call will be conducted within 14 business days after the 
procedure to verify that there has been no change in their clinical status. If a clinical status change 
has occurred (ie. New onset of an AE or worsening condition after day of procedure), then the 
adverse event should be documented and followed until event resolution or until site is closed by 
the Sponsor. If no change has occurred, the subject can then be exited from the study. 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 29 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
 
In the event a subject does not answer the initial follow-up call, there must be at least two 
additional, documented attempts to contact the subject within the 14 business day follow up 
timeframe. If after the additional calls a subject does not answer, they will then be considered lost 
to follow up. 
31) 
Statistical Analysis 
32) 
Sample Size Determination 
The study is planned to enroll at fifteen sites and will enroll until 115 subjects are identified with 
inadequate bowel prep.  
Assuming a 12% inadequate prep rate 1067 patients would be enrolled to achieve 115 patients 
inadequate bowel preparation. The final sample size, however, will be determined by the number 
needed to undergo colonoscopy to achieve 115 and therefore may be greater than or less than 
1067. 
The sample size of 115 was determined to provide at least 90% power for the primary endpoint of 
demonstrating conversation rate of inadequate colonoscopies after the use of the Pure-Vu EVS 
System is greater than a 30% performance goal. 
 
Assuming a true conversion rate of 50%, then 115 inadequately prepped patients undergoing Pure-
Vu with the opportunity to convert to adequate prep will provide  99% power and at least 115 
patients for safety.  To be conservative, 115 inadequately prepped patients will provide  90% 
power to produce an exact 95% CI > 30% even if the true conversion rate is 45%. 
33) 
Description of Statistical Methods 
Basic demographic and other baseline characteristics will be collected and analyzed for all subjects. 
Unless specified otherwise, descriptive statistics will be presented for the total study population, 
by colonoscopy prep adequacy group, and overall. Subgroup analyses may occur, including but not 
limited to age group (40 to <65 vs 65 to 80), insurance type, site care location, and colonoscopy 
indication, all of which will be further described in the Statistical Analysis Plan (SAP).  For 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 30 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
quantitative summaries, mean, standard deviation (SD), median, minimum, and maximum will be 
presented. For qualitative summaries, counts and percentages will be presented.  
34) 
Safety Population 
The safety population is defined as any subject presented for procedure and enrolled into the study. 
This population will be used for all safety analyses. 
35) 
Intent-to-Treat (ITT) Population 
The ITT population is defined as any subject who was able to proceed with an optical colonoscopy 
and have a complete procedure or an incomplete procedure solely due to inadequate bowel prep. 
This population will be used for all efficacy analyses.  A completed procedure is defined as one 
with the ability to reach the cecum with OC either before or after Pure-Vu.  
36) 
Per Protocol (PP) Population 
The PP population is defined as any subject in the ITT who do not have any major protocol 
deviations and in whom the Pure-Vu system was utilized as planned. This population will also be 
used for all efficacy analyses.  
37) 
Inadequate Bowel Preparation (IBP) Population 
The IBP population is defined as any subject that were identified to have inadequate prep after 
initial OC and were indicated for cleansing with the Pure-Vu System and did not have any major 
protocol deviations.  
 
 
38) 
Primary Endpoint Analysis 
The primary endpoint is conversion rate of inadequate colonoscopies to adequate colonoscopies 
after the use of the Pure-Vu EVS System, where inadequate OCs defined as such if any of the 
following are met: 
• BBPS < 6 (Adequacy is defined as BBPS of 2 or greater in each segment) 
• Inability to identify >5mm polyps 
 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 31 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
The conversion rate, , is defined as number of preps inadequate with SOC and adequate after 
Pure-VU EVS System divided by the number of preps inadequate with SOC.   
H0:   0.30 
H1:  > 0.30 
The conversion rate and its two-sided 95% exact binomial interval will be presented and 
compared to the 30% performance goal.  The proportion of preps inadequate after SOC and 
inadequate after SOC + Pure-Vu will also be reported. 
 
39) 
Secondary Endpoint Analysis 
All secondary endpoints will be summarized using descriptive statistics and full details on 
additional planned analyses with be provided in the prospective Statistical Analysis Plan.   
40) 
Tertiary Endpoint Analysis  
All tertiary endpoints will be summarized using descriptive statistics and full details on additional 
planned analyses with be provided in the prospective Statistical Analysis Plan.   
41) 
Safety Endpoint Analysis 
All adverse events (AE) and serious adverse events (SAE) that are definitely and/or potentially 
attributed to Pure-Vu will be summarized using descriptive statistics. 
42) 
Adverse Events and Classifications 
AE and AE subcategories are defined per GCP and CFR. 
43) 
Adverse Event (AE) 
An AE is any untoward medical occurrence in a subject, which does not necessarily have a causal 
relationship with the treatment. An AE can be any unfavorable and unintended sign (such as an 
abnormal laboratory finding), symptom, or disease temporarily associated with the use of the study 
device, whether it is considered to be study device related. This includes any newly occurring event or 
previous condition that has increased in severity or frequency since enrollment in the study.  
44) 
Serious Adverse Event (SAE) 
An adverse event will be considered serious if it meets at least one of the following criteria, regardless 
of causality or relationship to the study device:  

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 32 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
• Death- results in fatality  
• Life-threatening – subject was at an immediate risk of death from the reaction as it 
occurred. 
o Life threatening means that the subject was, in the view of the investigator, at 
immediate risk of death from the reaction as it occurred. This does not include 
an AE that, if more severe, might have caused death. 
• Hospitalization (Initial or Prolonged) - Requires inpatient hospitalization or prolongs a 
hospital stay during the period of the therapy and/or within 24 hours after completion 
of study exit. 
• Disability or Permanent damage - A substantial disruption of a person’s ability to 
conduct normal life’s functions. 
• Congenital anomaly/birth defect - If exposure to the device prior to conception or 
during pregnancy may have resulted in an adverse outcome in a child. 
• Requires intervention to prevent permanent damage - an intervention is required to 
prevent permanent damage. 
• Important Medical Event - Events that may not result in death, be life-threatening, or 
require hospitalization may still be considered SAEs when, based upon appropriate 
medical judgment, they are felt to jeopardize the subject and may require medical or 
surgical intervention to prevent one of the outcomes listed above. 
 
45) 
Adverse Device Effect (ADE) 
An Adverse Device Effect (ADE) is an AE related to the use of an investigational medical device.  
This definition includes AEs resulting from insufficient or inadequate instructions for use, 
deployment, implantation, installation, or operation, or any malfunction of the investigational 
medical device. 
This definition includes any event resulting from use error or from intentional misuse of the 
investigational medical device. 
46) 
Serious Adverse Device Effect (SADE) 
A Serious Adverse Device Effect is an anticipated adverse device effect that has resulted in any of 
the consequences characteristic of an SAE. 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 33 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
47) 
Unanticipated Adverse Device Effect (UADE) 
An Unanticipated Adverse Device Effect is an adverse device effect which by its nature, incidence, 
severity, or outcome has not been identified in the current version of the risk analysis report.  
48) 
Unanticipated Serious Adverse Device Effect (USADE) 
An Unanticipated Serious Adverse Device Effect is a serious adverse device effect which by its 
nature, incidence, severity, or outcome has not been identified in the current version of the risk 
analysis report.  
49) 
 Classification of Event Severity, Relationship and Outcomes 
50) 
Adverse Event Severity Classification  
Severity will be defined according to the following criteria: 
• Mild: Awareness of event, but easily tolerated 
• Moderate: Discomfort enough to cause some interference with activities of daily living 
(ADL) 
• Severe: Considerable interference with ADL, may be incapacitating and may require 
hospitalization 
An AE can be classified as severe and not deemed a SAE. Similarly, a SAE is not automatically severe 
in nature. 
51) 
Adverse Event Relationship Classification  
Relationship to study device administration will be determined as follows: 
● No Relationship: No relationship between the AE and the administration of study device 
and a known relationship to other etiologies such as concomitant medications, 
procedure, or subject’s clinical state. 
● Possible Relationship: An AE that follows a reasonable temporal sequence from 
administration of the study device and follows a known response pattern to the study 
device but could have been produced by the participant’s clinical state or by other 
therapies. 
● Probable Relationship: An AE that follows a reasonable temporal sequence from 
administration of the study device; follows a known response pattern to the study 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 34 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
device; and cannot be reasonably explained by the known characteristics of the 
participant’s clinical state or by other therapies. 
● Definite Relationship: An AE that follows a plausible temporal sequence from 
administration of the study device and follows a known response pattern to the study 
device. The reaction cannot be reasonably explained by the known characteristics of the 
subject’s clinical state or other therapies administered to the subject. 
● Unknown/Impossible to Determine: Given the information available, sequence and timing 
of events, it is unknown or impossible to determine the relationship of the AE with the 
study device. 
52) 
Adverse Event Outcome Classification 
Outcome of the event will be defined according to the following:  
● Resolved: The event has fully resolved at the end of the study. 
● Resolved with sequelae: The event has resolved but retained pathological conditions 
resulting from the prior disease or injury. 
● Ongoing: The event is ongoing at the end of the study. 
● Death: This event is determined to be the cause of death. 
53) 
Device Deficiencies 
A device deficiency is an inadequacy of a medical device related to its identity, quality, durability, 
reliability, safety, or performance, such as malfunction, misuse or use error and inadequate 
labeling. 
 
All device deficiencies will be documented, and the device should be returned to Motus GI for 
analysis, if possible. Instructions for returning the investigational device will be provided. Device 
deficiencies should also be documented in the subject’s medical record. 
 
Device deficiencies are NOT AEs. However, if there is an AE that results from a device deficiency, 
that specific event would be recorded on the appropriate CRF. 
54) 
Adverse Event Recording and Reporting 
Assessment of the occurrence of an AE will be based on changes in the subject’s signs and 
symptoms. AEs will be monitored until a subject completes the study unless the Investigator 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 35 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
determines the event is related to the investigational device, in which case they will be monitored 
until resolution if possible. Medical care will be provided, as defined in the informed consent, for 
any AE related to study participation. AEs will be collected on an AE eCRF and applicable source 
documentation.  
 
The following should not be considered an AE: 
● A condition requiring a preplanned procedure unless the condition worsened since 
screening 
● A preexisting condition found as a result of screening, unless the condition has worsened 
since enrollment. 
All relevant AEs observed during this study, regardless of severity or relationship to the study 
device will be recorded on the appropriate eCRF.  All relevant AEs are associated complications 
expected during colonoscopies, use of the Pure-Vu System, bowel preparation or anesthesia.  It 
will be the responsibility of the reporting PI to determine if the AE is relevant.   
55) 
Reporting Responsibilities 
An investigator shall submit to the sponsor and to the reviewing IRB a report of any SAEs, ADEs, 
SADEs, UADEs, USADEs, and device deficiencies that could have led to a serious adverse device 
effect occurring during an investigation within 24 hours of learning of the event, but in no event 
later than 10 working days after the investigator first learns of the effect. The sponsor will evaluate 
all AEs and device malfunctions and evaluate whether those are complaints and meet FDA’s 
requirements for MDR reporting.  These events will be reportable per the complaint procedure and 
FDA’s MDR regulation (21 CFR Part 803). 
56) 
Ethics and Compliance 
57) 
Statement of Compliance 
This clinical investigation will be conducted in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki, ICH-GCP, and any regional or national regulations, as 
appropriate. 
 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 36 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
This may include an inspection by Motus GI representatives and/or Regulatory Authority 
representatives at any time. The investigator must agree to the inspection of study-related 
records by the Regulatory Authority/ Motus GI representatives and must allow direct access to 
source documents to the Regulatory Authority/ Motus GI representatives. Regulatory Authority 
approvals/authorizations/notifications, where required, will also be in place and fully 
documented prior to study start. 
58) 
Protocol Compliance 
No changes to the study protocol will be permitted without the written approval from Motus GI 
and the IRB. The investigator must notify Motus GI and the reviewing IRB of any deviation from 
the study protocol when specific to the protection of the life or physical well-being of a subject in 
an emergency. Such notice must be given as soon as possible. Except in such an emergency, prior 
written approval by Motus GI is required for changes in or deviations from the protocol. If these 
changes or deviations affect the scientific soundness of the Plan or the rights, safety, or welfare 
of human subjects the IRB will also be notified. All other deviations will be reported per the site’s 
IRB deviation policy. Should any deviations from the study protocol occur, these will be reviewed 
by Motus GI for their clinical significance. If the event is performed without written approval from 
all parties, the investigator may be terminated from the study. 
59) 
Institutional Review Board (IRB) 
Documented approval from the appropriate Institutional Review Board (IRB) per 21 CFR Part 56 
will be obtained for all participating centers prior to study start, according to ICH GCP, local laws, 
regulations, and organization. When necessary, an extension, amendment, or renewal of the IRB 
approval must be obtained. The IRB must supply to the sponsor a list of the IRB membership and 
a statement to confirm that the IRB is organized and operates according to GCP and applicable 
laws and regulations. 
60) 
Subject Informed Consent 
Prior to the beginning of the trial, the investigator must have the IRB written approval of the ICF 
and any other written information to be provided to subjects. The written approval of the IRB 
together with the approved ICFs must be filed in the study files. 
The process of obtaining informed consent must be in accordance with applicable regulatory 
requirement(s) (e.g. 21 CFR Part 50) and must adhere to GCP and to the ethical principles 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 37 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
originating in the Declaration of Helsinki. Written/electronic informed consent must be obtained 
before any study specific procedure takes place. Participation in the trial and date of informed 
consent given by the subject should be documented appropriately in the subject files. 
61) 
Insurance 
All subjects participating in the trial will have insurance coverage by the Sponsor, in accordance to 
applicable local laws. 
62) 
Confidentiality 
All records identifying the subject will be kept confidential and, to the extent permitted by the 
applicable laws and/or regulations, will not be made publicly available.  
Subject names will be kept confidential. Study findings stored on a computer will be stored in 
accordance with local data protection laws. The subjects will be informed in writing that 
representatives of the sponsor, IRB or Regulatory Authorities may inspect their medical records to 
verify the information collected, and that all personal information made available for inspection will 
be handled in strictest confidence and in accordance with local data protection laws. Subjects will 
also be informed that information regarding the study that does not include subject identifiers will be 
posted on clinicaltrials.gov. 
 
If the results of the trial are published, the subject’s identity will remain confidential.  
The investigator will maintain a list to enable subjects’ records to be identified. 
63) 
Use of Data and Publications 
Information regarding the study and study data will be made available via publication on 
clinicaltrials.gov.  
 
All data and results and all intellectual property rights in the data and results derived from the study 
will be the property of Motus GI, who may utilize the data in various ways, such as for submission to 
government regulatory authorities or disclosure to other investigators, educational, further product 
development and marketing uses.  
 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 38 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
The investigators, while free to utilize data derived from the study for scientific purposes, must 
discuss any publication with the sponsor prior to release and obtain written consent of the sponsor 
on the intended publication. The sponsor recognizes the right of the investigator to publish the 
results upon completion of the study. However, the investigator must send a draft manuscript of the 
publication or abstract to the sponsor 45 days in advance of submission in order to obtain approval 
prior to submission of the final version for publication. This will be reviewed promptly, and approval 
will not be withheld unreasonably. In case of a difference of opinion between the sponsor and the 
investigator(s), the contents of the publication will be discussed in order to find a solution which 
satisfies both parties.  This timeline can be shortened at the mutual agreement of sponsor and 
investigators.  
 
Disclosure of involvement in a publication (e.g., sponsor of the study; collection, analysis, and 
interpretation of data; professional writing assistance) must be as specified by journal-specific 
policies, submission requirements, and prevailing editorial standards, in addition to those specified 
by International Committee of Medical Journal Editors. Authors must ensure that an 
acknowledgement/disclosure statement is included in the body of the manuscript for Motus GI to 
review for accuracy. All authors must also disclose financial or personal affiliations that could be 
considered conflicts of interest as per journal requirements.  
64) 
Study Monitoring 
Site monitoring visits will be conducted by an authorized Motus GI representative or designee to 
inspect study data, subjects’ medical records, and eCRFs in accordance with the Clinical Monitoring 
Plan (CMP), current ICH GCPs, Declaration of Helsinki and the applicable local and national regulations.  
To ensure the rights, safety, and welfare of study subjects are being maintained, the monitor will 
review training records to ensure all study staff are trained on the study protocol and use of the study 
device. 
 
The Study Investigator and the investigating site will permit authorized clinical research personnel and 
clinical monitors from Motus GI and/or designee(s) employed by Motus GI to review completed eCRFs, 
IRB decisions, clinical site records, and facilities relevant to this study at regular intervals throughout 
the study per the CMP.  In instances where data protection regulations prohibit the direct examination 
of hospital records by the study Sponsor or designee(s), the Investigator will provide another 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 39 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
mechanism of access to allow source data verification by the Sponsor or designee. Monitoring may be 
performed with in person visits or remotely, when applicable.  
 
The monitor will verify that each subject has consented in writing (or electronic) to directly access to 
the original source data/hospital records by the use of written patient information and signed informed 
consent.  During monitoring, the data recorded in the eCRFs by the investigator or designee will be 
compared for consistency with the source data/hospital records by the monitor to ensure protocol 
adherence and source data verification.  
 
If the monitor discovers that an investigator is not complying with the signed Investigator Agreement, 
the investigational plan, applicable laws, or any conditions of approval imposed by the reviewing IRB, 
the monitor will report to the Sponsor and take such steps necessary to promptly secure compliance. 
65) 
Data Collection and Processing  
This study will utilize an electronic database.  Data management and data quality control will be 
performed by the Clinical Research Organization (CRO).  Data will be entered into an 21 CFR Part 11 
compliant Electronic Data Capture (EDC) system by the clinical sites.  Any data queries will be issued 
to the sites as required for resolution and entered into the database. Only delegated personnel and 
PIs trained to use the EDC will have access for data entry.  Only trained clinical team members and 
Data Managers from the Sponsor or CRO will have access to the EDC for monitoring and Data 
Management purposes in accordance with the Data Management Plan (DMP).   
 
The investigators shall ensure the accuracy, completeness and timelines of the data reported in the 
electronic Case Report Forms (eCRFs) and in all required documentation. Data reported on the eCRF 
shall be supported by the source documents with any discrepancies being explained. All digital or 
paper hospital records regarding the treatment of the subject are considered source data.  If an item 
is unavailable or is not applicable, this fact should be indicated; no space is to be left blank. The eCRFs 
are to be completed in a timely manner after the subject’s visit.   Once monitoring is complete and all 
queries are resolved, the investigator who has signed the study protocol signature page or his/her 
authorized designee is to personally sign the eCRFs to validate that the observations and findings are 
recorded on the eCRFs correctly and completely. 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 40 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
66) 
Study Supplies and Device Accountability  
67) 
Packaging 
The Pure-Vu EVS System disposables are composed of biocompatible materials and are supplied 
clean in a sealed package. The shelf life of the device was tested within the device verification and 
validation process to support shelf-life period of 12 months. 
68) 
Labeling 
All the disposable packages are labeled as single use with a lot number and expiration date.  
69) 
Inventory Control 
The sponsor will initiate shipment of the product from the sponsor to the site upon receiving all 
required documents (e.g., approval/favorable opinion from IRB). The sponsor will maintain tracking 
for all shipment documentation. Prior to any shipment, the site will be informed by the sponsor of 
the upcoming shipment, expected arrival date, and content of the shipment. The site should 
confirm receipt of the shipment. The site will file the Sponsor’s Shipping Receipt in the Sponsor’s 
Study File. 
An Investigator’s Device Accountability form will be completed and filed in the Regulatory Binder 
at each site.  In case of technical failure, the site will inform the designated sponsor contact.  
For each dispensed Pure-Vu Oversleeve, the following relevant information should be 
documented: subject study number, Date Oversleeve used, Oversleeve lot number and expiration 
date.  
At the termination of the study, all unused study material must be returned with the corresponding 
documentation as directed by Motus GI.  

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 41 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
70) 
General Information 
71) 
Study Contact Information  
Clinical Affairs 
Caitlyn Seidl 
VP of Clinical Affairs 
1301 E. Broward Blvd. #310 
Fort Lauderdale, FL 33301 
 
Phone: 954-541-8000 
Mobile: 352-514-4260 
Email: cseidl@motusgi.com 
 
72) 
Retention of Records 
All source documents and eCRFs will be kept for a period of two years from the study termination 
or completion or for the period required by applicable laws.   
73) 
Study Completion and Termination of Study 
Motus GI reserves the right to discontinue the study at any stage, with suitable written notice to 
all investigators and reviewing IRBs, following unforeseen events or other factors that do not 
permit continuation of the study. Similarly, investigators may withdraw from the study at any time, 
subject to providing written notification to Motus GI 30 days prior to the date they intend to 
withdraw. However, Motus GI and investigators will be bound by their obligation to complete the 
follow-up of subjects already participating in the study. The subjects must be followed according 
to the clinical protocol, and information obtained during subject follow-up shall be reported to 
Motus GI in the database. 
 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 42 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
The appropriate IRB will be notified of discontinuation of the trial for any reason not later than 5 
working days after the sponsor makes this determination and not later than 15 days after the 
sponsor receives a notice from the IRB and/or regulatory authority. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
74) 
References 
1. 
iData Research. “An Astounding 16.6 Million Colonoscopies Are Performed Annually in the United 
States.” IData Research, 8 Feb. 2022, https://idataresearch.com/an-astounding-19-million-
colonoscopies-are-performed-annually-in-the-united-

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 43 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
states/#:~:text=An%20Astounding%2016.6%20Million%20Colonoscopies%20are%20Performed%20An
nually%20in%20The%20United%20States,-08%2F08%2F2018.  
2. 
Joseph, Djenaba A et al. “Colorectal cancer screening: Estimated future colonoscopy need and current 
volume and capacity.” Cancer vol. 122,16 (2016): 2479-86. doi:10.1002/cncr.30070 
3. 
Biggers, Larissa. “A Brief History of Colonoscopy.” Colonoscopy Compression Device, 
https://www.colowrap.com/blog/history.  
4. 
Shah, Saloni A., et al. “Factors Affecting Outpatient Bowel Preparation for Colonoscopy.” International 
Journal of Gastrointestinal Intervention, vol. 8, no. 2, 2019, pp. 70–73., https://doi.org/10.18528/ 
5. 
Murphy, Christopher John, et al. “Outcomes of next-Day versus Non-next-Day Colonoscopy after an 
Initial Inadequate Bowel Preparation.” Digestive Diseases and Sciences 
6. 
Gupta, Samir, et al. “Recommendations for Follow-up after Colonoscopy and Polypectomy: A 
Consensus Update by the US Multi-Society Task Force on Colorectal Cancer.” Gastrointestinal 
Endoscopy, vol. 91, no. 3, 2020, https://doi.org/10.1016/j.gie.2020.01.014.  
7. 
Calderwood, Audrey H., et al. “Recommendations for Follow-up Interval after Colonoscopy with 
Inadequate Bowel Preparation in a National Colonoscopy Quality Registry.” Gastrointestinal 
Endoscopy, vol. 95, no. 2, 2022, https://doi.org/10.1016/j.gie.2021.09.027.  
8. 
Gross S, Gerson L, Lewis B, Ganz R. A novel device for improving visualization in an inadequately 
prepared colon. Gastrointest Endosc. 2017. 
9. 
van Keulen KE, Neumann H, Schattenberg JM, van Esch AAJ, Kievit W, Spaander MCW, Siersema PD. A 
novel device for intracolonoscopy cleansing of inadequately prepared colonoscopy patients: a 
feasibility study. Endoscopy. 2019 Jan;51(1):85-92. doi: 10.1055/a-0632-1927. Epub 2018 Jul 11.  
10. 
Pérez Jiménez J1, Diego Bermúdez L1, Gralnek IM2,3, Martín Herrera L1, Libes M4. An Intraprocedural 
Endoscopic Cleansing Device for Achieving Adequate Colon Preparation in Poorly Prepped Patients. J 
Clin Gastroenterol. 2019 Aug;53(7):530-534 
11. 
Helmut Neumann ML, Tim Zimmermann, Gabriel Lang, Jason B. Samarasena, Seth A. Gross, Bhaumik 
Brahmbhatt, Haleh Pazwash, Vladimir Kushnir. EVALUATION OF BOWEL CLEANSING EFFICACY IN 
HOSPITALIZED PATIENT POPULATION USING THE PURE-VU SYSTEM. Gastrointestinal Endoscopy. 
2019;89(6). 
12. 
Fisher, Deborah A., et al. “Complications of Colonoscopy.” Gastrointestinal Endoscopy, vol. 74, no. 4, 
2011, pp. 745–752., https://doi.org/10.1016/j.gie.2011.07.025.  
 
75) 
Appendices 
 
Appendix A: Study Design and Schedule of Assessment 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 44 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
Assessment 
 
Screening 
/Pre-
Procedure 
 
(Up to-120 
days) 
Day of 
Procedurea 
 
 
(Day 0) 
 
Follow Up 
 
 
 
(1-14 days post 
procedure) 
 
Informed Consent and 
Demographic details 
X 
X 
 
Inclusion/Exclusion Criteria 
X 
X 
 
Concomitant Medications 
X 
X 
 
Medical & Surgical History 
X 
X 
 
Body Mass Index 
 
X 
 
Bowel Preparation Regimenb 
And Clarity Assessment 
 
X 
 
Colonoscopy Procedure 
 
X 
 
Adverse Events Reporting 
 
X 
Xc 
Clinician Satisfaction  
(only for study device procedures) 
 
X 
 
aIn the event that patients are screened and enrolled on the same day, all activities must be 
completed prior to subject entry into the endoscopy suite 
bBowel Preparation Regimen information will be collected.  Subject must have attempted and or 
completed bowel preparation to be eligible for study continuation 
cPost procedure follow up call will be conducted to ensure reporting of any potential adverse events 
from the day of procedure 
 
 
 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 45 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
Appendix B: Boston Bowel Preparation Scale 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
❖ A: Score 0- Unprepared colon segment with mucosa not seen due to solid stool that cannot 
be cleared.  
❖ B: Score 1 - A portion of the mucosa of the colon segment is seen, but other areas of the 
colon segment are not seen well due to staining, residual stool, and/or opaque liquid. 
❖ C: Score 2- A minor amount of residual staining, small fragments of stool, and/or opaque 
liquid are visible, but the mucosa of the colon segment are seen well. 
❖ D: Score 3- The entire mucosa of the colon segment is seen well with no residual staining, 
small fragments of stool, or opaque liquid.  
 
 
 
 
 
 
 
 

 
 
CONFIDENTIAL 
Document Title:                                                           Outpatient 
Colonoscopy: Demonstrating Effective Salvage of 
Inadequate Colonoscopies Utilizing the Pure-Vu EVS 
System 
Document No.  
CL00052 
Amendment 
2.0 
Page 46 of 46 
 
CL00052 Protocol, Amendment 2; October 31, 2022   
Appendix C: Clarity Card 
 
  
  
  
         Grade 1  
        Grade 2  
         Grade 3 
 
 
  
 
 
 
 
 
        Grade 4  
 
       Grade 5