Evaluation of the Bowel Cleansing in Hospitalized Patients Using Pure-Vu System
Phase: NA
Conditions: Gastrointestinal Disease, Colorectal Cancer
Sponsor: Motus GI Medical Technologies Ltd

 
 
CONFIDENTIAL 
Document Title: 
Document No.  
Version 
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Evaluation of the bowel cleansing in hospitalized 
population using Pure-Vu System 
CL00044 
4.0 
 
 
 
  
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Page 1 of 44 
 
 
 
 
Clinical Investigational Plan (CIP) INFORMATION 
Title: 
Evaluation of the bowel cleansing in hospitalized population using 
Pure-Vu System 
CIP Number: 
CL00044 
Version Date: 
January 30, 2019 
Version: 
4.0 
Sponsor: 
Motus GI Medical Technologies LTD. 
Address: Keren Hayesod 22, Tirat Carmel, ZIP 3902638, Israel 
Tel: +972-4-
 
6214446  
Fax: +972-4-
 
6214442  
 
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. 
 
 
Summary of Changes to CIP 
Version 
Section 
Description of Change 
Reason for Change 
1.0 
NA 
• 
NA 
NA -Initial 
2.0 
All 
• 
Overall changes to wording 
• 
Changed from Patient to Subject 
• 
Changed to study design to 
exclude bowel prep as part of the 
study  
• 
Updated study diagram  
 

 
 
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• 
Case Report Forms have been 
taken out and will remain 
standalone documents 
3.0 
All 
• 
Updates to the inclusion and 
exclusion criteria 
• 
Updates on wording 
Updates based on Interim Analysis  
4.0 
Study 
design 
• 
Expanded enrollment per site 
from 25 to 35 
Due to enrollment delays 
 
 
 
 
 

 
 
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1.0 Signature Page 
 Investigator Signature Page 
Title: 
Evaluation of the bowel cleansing in hospitalized population using 
Pure-Vu System 
CIP Number: 
CL00044 
Version Date: 
January 30, 2019 
Version: 
4.0  
 
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 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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2.0 Table of Contents 
1.0 
Signature Page .................................................................................................................... 3 
2.0 
Table of Contents ................................................................................................................ 4 
3.0 
Protocol Synopsis................................................................................................................ 7 
4.0 
Acronyms and Definitions ................................................................................................ 10 
5.0 
Introduction ....................................................................................................................... 11 
5.1 
Background .................................................................................................................... 11 
6.0 
Study Device ..................................................................................................................... 12 
6.1 
General Description........................................................................................................ 12 
6.1.1 
Work Station (WS) ................................................................................................. 13 
6.1.2 
Oversleeve............................................................................................................... 14 
6.1.3 
WS Connector ......................................................................................................... 15 
6.1.4 
Ancillary Apparatus ................................................................................................ 15 
6.2 
Pre-clinical data .............................................................................................................. 16 
6.3 
Clinical data to Date ....................................................................................................... 16 
7.0 
Risk/Benefit Analysis ....................................................................................................... 17 
7.1 
Anticipated Risks Associated with Pure-Vu System conjunction with a colonoscope.. 17 
7.2 
Anticipated Risks Associated with bowel preparation agents ....................................... 18 
7.3 
Residual risk associated with the study device .............................................................. 18 
7.4 
Potential Benefits to the Subject .................................................................................... 19 
8.0 
Study Objectives ............................................................................................................... 19 
8.1 
Primary objective ........................................................................................................... 19 
8.2 
Secondary objectives: ..................................................................................................... 19 
9.0 
Study Endpoints ................................................................................................................ 20 
9.1 
Primary endpoints .......................................................................................................... 20 
9.2 
Secondary endpoints ...................................................................................................... 20 
10.0 
Study Design ..................................................................................................................... 20 

 
 
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Study Flowchart ........................................................................................................................ 21 
11.0 
Subject Selection and Enrollment ..................................................................................... 22 
11.1 
Inclusion Criteria ........................................................................................................ 22 
11.2 
Exclusion Criteria ....................................................................................................... 22 
11.3 
Withdrawal Criteria .................................................................................................... 23 
11.4 
Selection of Investigators and Training ...................................................................... 23 
12.0 
Study Procedures .............................................................................................................. 24 
12.1 
Screening and Informed Consent ............................................................................... 24 
12.2 
Randomization ............................................................................................................ 25 
12.3 
Screen Failures ........................................................................................................... 25 
12.4 
Colon Preparation ....................................................................................................... 25 
12.5 
Colonoscopy procedure .............................................................................................. 25 
13.0 
Statistical Analysis ............................................................................................................ 27 
13.1 
Sample Size Determination ........................................................................................ 27 
13.2 
Description of statistical methods............................................................................... 28 
13.3 
Primary Endpoint Analysis ......................................................................................... 28 
13.4 
Secondary Endpoints Analysis ................................................................................... 28 
Safety Analysis ......................................................................................................................... 28 
Efficacy Analysis ...................................................................................................................... 29 
13.5 
Analysis Populations .................................................................................................. 29 
13.6 
Interim Analyses ......................................................................................................... 30 
14.0 
Adverse Events (AEs) and Complications ........................................................................ 30 
14.1 
Adverse Event (AE) .................................................................................................... 30 
14.2 
Serious Adverse Event (SAE) .................................................................................... 30 
14.3 
Adverse Device Effect (ADE) .................................................................................... 31 
14.4 
Serious Adverse Device Effect (SADE) ..................................................................... 31 

 
 
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14.5 
Unanticipated Serious Adverse Device Effect (USADE) .......................................... 32 
14.6 
Adverse Event Severity Classification ....................................................................... 32 
14.7 
Adverse Event Relationship Classification ................................................................ 32 
14.8 
Adverse Event Outcome Classification ...................................................................... 33 
14.9 
Device Deficiencies .................................................................................................... 33 
14.10 
Adverse Event Recording and Reporting ................................................................... 34 
14.11 
Reporting Responsibilities .......................................................................................... 34 
15.0 
Ethics and Compliance ..................................................................................................... 35 
15.1 
Statement of Compliance ............................................................................................ 35 
15.2 
Protocol Compliance .................................................................................................. 35 
15.3 
Institutional Review Board (IRB)/Ethics Committee (EC) ........................................ 36 
15.4 
Subject Informed Consent .......................................................................................... 36 
15.5 
Insurance ..................................................................................................................... 36 
15.6 
Confidentiality ............................................................................................................ 36 
15.7 
Use of Data and Publications...................................................................................... 37 
16.0 
Monitoring Procedures...................................................................................................... 38 
16.1 
Data Collection and Processing .................................................................................. 39 
17.0 
Study Supplies and Device Accountability....................................................................... 40 
17.1 
Packaging.................................................................................................................... 40 
17.2 
Labeling ...................................................................................................................... 40 
17.3 
Inventory Control ....................................................................................................... 40 
17.4 
Retention of Records .................................................................................................. 41 
17.5 
Study Completion/Termination of Study ................................................................... 41 
18.0 
General Information .......................................................................................................... 42 
18.1 
Study Contact Information ......................................................................................... 42 
19.0 
References ......................................................................................................................... 42 

 
 
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20.0 
Appendixes A: Study Design and Schedule of Assessment ............................................. 43 
21.0 
Appendix B: Boston Bowel Preparation Scale ................................................................. 44 
 
3.0 Protocol Synopsis 
Study Summary 
Study Purpose 
The aim of this study is to evaluate the potential improvement in 
colonoscopy procedure's outcomes when using the Pure-Vu System in 
hospitalized subjects who are indicated for colonoscopy procedure.  
Objective 
The primary objective of this study is to evaluate the bowel cleansing 
after Pure-Vu use in hospitalized subjects, which may increase the 
likelihood of a successful colonoscopy examination.  
Study procedures 
 Eligible subjects will be consented and enrolled  
 Following standard bowel preparation, the nurse or study coordinator 
will be asked to complete a questionnaire about the subjects’ 
baseline preparation condition prior to the colonoscopy procedure. 
 Subjects will undergo colonoscopy procedure with Pure-Vu System. 
 In case of inadequate bowel preparation as defined as BBPS < 2 in at 
least one of the colon segments, prior Pure-Vu use, the physician will 
complete a questionnaire on the patient’s management standard of 
care assuming the absence of Pure-Vu.   
 
Protocol Number 
CL00044 
Protocol Title 
Evaluation of the bowel cleansing in hospitalized population using Pure-
Vu System Ver. 4.0 

 
 
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Study Sponsor  
Motus GI Medical Technologies,  
Keren Hayesod 22, Tirat Carmel, ZIP 3902638, Israel 
Tel: +972 (4) 6214446/103 
Fax: +972 (4) 6214442 
Sponsor 
Representative 
Hagit Ephrath 
VP Health Economics, Regulatory and Clinical Affairs 
Study Type 
Multicenter, prospective, feasibility study 
Study Product 
Pure-Vu System  
Study Phase 
Post-market 
510 (k) Number 
K181437 Class II 
Study Location 
United States and Europe 
Study Duration 
Study period will last approx. 12 months  
Planned Follow-Up 
Follow-up will be conducted at 2 working days post-procedure to 
assess subject well-being and capture any adverse events. 
Subject Population 
Hospitalized subjects who are indicated for standard colonoscopy 
procedure and meet the eligibility criteria. 
Determination of 
Sample Size 
This is a pilot study that will include up to 100 subjects; no statistical 
considerations were made to determine the sample size. 
Planned # of Sites 
Up to 6 clinical sites 
Primary Endpoint 
The rate of improved cleansing level per segment will be evaluated 
by the Boston Bowel Preparation Score (BBPS) index.  

 
 
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Secondary Outcomes The following secondary outcomes will be determined: 
• Type, incidence, severity, relationship and duration of adverse 
events. 
• Cecum intubation rate 
• Proportion of subjects with successful colonoscopy for the 
intended indication in the first attempt. 
Randomization 
NA- single arm 
Eligibility Criteria 
Inclusion Criteria 
1. Hospitalized subjects who are indicated for a screening, 
diagnostic, surveillance or therapeutic colonoscopy  
2. Subjects’ age > 22 years 
3. Subject has signed the informed consent 
Exclusion Criteria 
1. Subjects with known Inflammatory Bowel Disease and / or 
active Colitis 
2. Subjects with active diverticulitis 
3. Subjects with known or detected (during colonoscopy) bowel 
obstruction 
4. Subjects with ascites Child Pugh C  
5. Subjects who are 30 days post-transplant 
6. Subjects under active IV inotropic medications 
7. Subjects with LVAD 
8. Subjects with known coagulation disorder (INR ≥ 2 or platelets 
<50,000) 

 
 
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4.0 Acronyms and Definitions 
ADE 
adverse device effect 
ADL 
activities of daily living 
AE 
adverse event 
CRF 
case report form 
EC 
Ethics Committee  
FDA 
Food and Drug Administration 
GCP 
good clinical practice 
GI 
gastrointestinal 
ICF 
informed consent form 
IFU 
Instruction for use 
ICH 
International Conference on Harmonisation 
IRB 
institutional review board 
ISO 
International Organization for Standardization 
OC 
optical colonoscopy 
DCBE 
double contrast barium enema 
9. Subjects with medical and/or hemodynamic instability.  
10. Pregnancy (as stated by subject) or breast feeding 
11. Subjects with altered mental status/inability to provide 
informed consent 
12. Subjects who have participated in another interventional 
clinical study in the last 2 months 
Interim analyses 
Interim analysis will be done after first 45 subjects enrolled 

 
 
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CT 
computed tomography 
MagC 
Magnesium Citrate 
SAE 
serious adverse event 
SADE 
serious adverse device effect  
USADE 
unanticipated serious adverse device effect  
WS 
Workstation 
WSC 
Workstation Connector 
BBPS 
Boston Bowel Preparation Scale 
5.0 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.  
5.1 
Background  
Colorectal cancer is the third most common cancer in men and the second most common cancer 
in women worldwide (2). In the United States, approximately 134,490 new cases are estimated 
for 2016 with approximately 49,190 deaths (8.0% of all cancer deaths) (3). Because colorectal 
cancer tends to develop slowly, screening and early detection can significantly reduce both the 
incidence and associated mortality of the disease (4).  
Optical colonoscopy (OC) is considered the gold standard method for the evaluation of subjects 
with suspected colonic disease. A key factor for ensuring high quality colonoscopy and 
successful screening is good colon preparation.  Bowel preparation prior to colonoscopy is one 
of the major barriers to patient compliance estimated as many as 38% of patients do not complete 
the bowel preparation due to palatability and/or intolerance to the large volume. Inadequate 
preparation is a major obstacle for achieving a high-quality colonoscopy (6).  
Inpatient status is one of several factors associated with poor bowel preparation leading to 
incomplete colonoscopy procedures, which in turn may cause increased patient morbidity, 
missed pathology, prolonged hospital stay and increased cost. According to results from a 

 
 
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prospective study by Ness et al. (7) involving a cohort of 649 subjects, inpatient status is a risk 
factor for bowel preparation failure. Bowel preparation for hospitalized patients can be 
challenging due to the presence of ongoing acute illnesses, dehydration, comorbidities, and 
newly prescribed medications. Failure of bowel cleansing typically leads to aborting and re-
scheduling procedures after better preparation is achieved, which in turn leads to prolonged 
hospitalizations. 
Pure-Vu System enables colon cleansing during standard colonoscopy using a standard 
colonoscope with a length of 1630mm – 1710mm and a The Oversleeve, which fits over the 
colonoscope, is connected to an external workstation, generates fluid jets to break up the feces. 
The fecal matter & fluids are removed through the evacuation channels of the Oversleeve device 
into an external waste receptacle. 
This study is designed to evaluate the potential improvements in colonoscopy procedure 
outcomes when using the Pure-Vu System in hospitalized subjects who are indicated for 
colonoscopy procedure.  
6.0 Study Device 
6.1 
General Description 
The Pure-Vu System is Food and Drug Administration (FDA) cleared device, intended to 
connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared 
colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and 
other bodily fluids and matter, e.g. blood.  
The Pure-Vu System comprises the following components: 
• The Pure-Vu Workstation (WS) - controls the flow of gas (e.g. air) and water or saline to 
the Oversleeve device and the evacuation of fecal matter and fluids out of the body. 
• The disposable Oversleeve is mounted on top of the colonoscope allowing the physician 
to clean the colon. The Oversleeve is connected to WS via the WS Connector (WSC). 
• The disposable WS Connector is mounted onto the front panel of the WS and connects to 
the irrigation and sensing lines of the Oversleeve. 

 
 
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• The loading fixture is an ancillary device that is used to aid in loading the device on the 
colonoscope.  
• External reservoir for collecting the evacuated fecal matter and fluids  
• External foot pedals that operate the cleansing and evacuation process to be used by the 
investigator. 
Below is a drawing showing the various components of the system and where they connect to 
each other. 
 
 
 
 
 
 
 
 
 
 
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 Instruction for use (IFU). 
6.1.1 Work Station (WS) 
The WS controls the flow of gas (e.g. air) and water or saline to the Oversleeve device and the 
evacuation of fecal matter and fluids out of the body. The WS has the following main functions: 

 
 
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• Cleansing: Creates an irrigation stream, which is a mixture of liquid (water or saline) and 
air into the colon to break up fecal matter. The irrigation of air and liquid (water or 
saline) is referred to as “cleansing jets”. The cleansing has three modes, high, medium 
and low with medium being the default setting. The physician can operate the system as 
per his clinical judgment. It is important to note that the evacuation function noted below 
is active during cleansing so that fluid is input and removed from the colon 
simultaneously. 
• Evacuation: Removes fecal matter and fluids out of the colon. The evacuation function is 
active during the cleansing as previously noted and can also be used independently. 
During evacuation the system senses the pressure in the evacuation channel of the 
Oversleeve and if the pressure goes below pre-set limits will automatically reverse the 
flow to purge a potential blockage and then switch back to continue evacuation. The user 
also has the ability to manually purge the evacuation channel as well. 
• User interface: Consists of actuators and indicators on the WS itself as well as a foot 
pedal to activate the main functions of the system so that users’ hands are free to 
manipulate the colonoscope in a standard fashion. 
6.1.2 Oversleeve 
The Oversleeve is mounted on top of the colonoscope and is connected to WS via the WS 
Connector. The Oversleeve includes the following main components: 
• Tubing: Six (6) tubes (2 Pebax and 4 PVC) that support the irrigation, evacuation and 
sensing functions of the system. 
• Cleansing and Evacuation head: The Oversleeve’s distal part which contains irrigation 
ports, evacuation openings, and colon sensing port. 
• Inner sleeve: This sleeve attaches the Oversleeve to the colonoscope along its length. 
This sleeve is inflated to allow the colonoscope to be inserted through it and then deflated 

 
 
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to hold onto the colonoscope when it is navigated through the colon. The inner sleeve is 
also attached to the outer sleeve noted below on one side. 
• Outer sleeve: This sleeve covers the entire portion of the device that goes inside the colon 
keeping the tubes in position and providing a smooth surface to interface with the wall of 
the colon. The distal 28 cm of the sleeve is coated with hydrophilic coating to provide a 
lubricious surface to aid in advancing the system through the colon. 
• Inflation connector: Provides the port to pressurize the inner sleeve during the loading of 
the colonoscope and provides the entry location for the colonoscope to be inserted into 
the Oversleeve. 
6.1.3 WS Connector 
The disposable WS Connector is mounted onto the front panel of the WS and connects to the 
irrigation and sensing lines of the Oversleeve. 
The WS Connector slides into the groves on the WS and once in place the user activates the 
locking mechanism to hold the WS Connector in place and align the connections to the two 
sensors and the air source for the irrigation. The user will then place the tubing that is on the 
proximal side of the WS Connector into for irrigation. The evacuation tubing will form the 
Oversleeve will be placed into the channels on the WS Connector and then into the pump heads 
according to its color-coding. Last the user will connect a standard bag of saline or water to the 
irrigation line and the evacuation line to the recommended waste tank. 
6.1.4 Ancillary Apparatus 
The final part of the system is ancillary apparatus to aid in loading the device on a colonoscope.  
• The loading apparatus consists of a pressure source and a distal sealing plug to facilitate 
inflation of the inner sleeve of the device as well as a base to keep the Oversleeve in a 
stable position to allow insertion of the colonoscope through the inner sleeve. 

 
 
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6.2 
Pre-clinical data 
The Pure-Vu system was used by four experienced gastroenterologists in 35 Yorkshire cross 
swine (66% female) that received a reduced bowel preparation to ensure an inadequate bowel 
preparation at baseline. Prior to the colonoscopy the Pure-Vu was attached to the colonoscope 
and the baseline prep was assessed during insertion.  The Pure-Vu system was then employed to 
cleanse the colon and the prep was then assessed post-Pure-Vu use. 
No adverse effects and no failed or prematurely terminated cases were noted.  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 Pure-Vu (p <0.001) (mean BBPS score 3.0 ± 0.0).  The 
physicians found Pure-Vu easy and intuitive to operate.  The Pure-Vu system effectively cleaned 
inadequately prepped swine colons and found to be easy to use.   
6.3 
Clinical data to Date 
The Pure-Vu System was evaluated in ninety-seven subjects (54% males) from five sites using 
similar protocol. 
Pure-Vu was used in subjects indicated for a screening, diagnostic or surveillance colonoscopy.  
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, an 18 
to 24 hour clear liquid diet and a split dose of 20mg Bisacodyl. 
The cleansing quality was evaluated before and after use of the Pure-Vu System with the Boston 
Bowel Preparation Score (BBPS) (1). 
Two subjects were excluded from the analysis due to the followings:  One subject had breakfast 
on day of procedure and therefore was excluded from the cleansing efficacy and usability 
analysis due to non-compliance with the pre-procedural prep regimen.  The other subject was 
excluded because the device could not reach beyond the sigmoid colon due to the subject’s 

 
 
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anatomy, thus the physician used a slim colonoscope to complete the procedure and indicated 
that only a slim colonoscope would be able to advance past the sigmoid and into the cecum. 
The Pure-Vu significantly increased the number of subjects with an adequate cleansing level 
(BBPS >= 2 for all 3 colon segments) from 25%; CI 95% [17%, 35%] at baseline to 99%; CI 
95% [94%, 100%] after Pure-Vu. Cecum intubation rate was 98%; CI 95% [94%, 100%]). Mean 
post-treatment BBPS score was 8.7 ± 1.0 vs. 3.9 ± 2.2 prior to Pure-Vu use. Physicians were 
satisfied with the device’s use. No major difficulties were experienced when performing 
polypectomy and no serious adverse events were reported. 
7.0 Risk/Benefit Analysis 
7.1 
Anticipated Risks Associated with Pure-Vu System conjunction with a standard 
colonoscope 
The Pure-Vu is used in conjunction with a standard colonoscope during a colonoscopy 
procedure. Hence, the complications associated with using the Pure-Vu are anticipated to be 
similar to those associated with the colonoscopy procedure.  As with any colonoscopy procedure, 
when using the Pure-Vu there is some risk of bowel perforation, pain, infection or bleeding. 
Although the risks of the procedure with the Pure-Vu System are expected to be comparable to 
conventional colonoscope (0.35%), the device is an add-on to a standard colonoscope.  
The Pure-Vu system was tested in an animal study including 35 pigs and in preliminary clinical 
studies including 97 subjects.  
No major complication or serious adverse events occurred within the course of those studies. 
In addition, these clinical studies demonstrated an excellent cleansing effectiveness; Pure-Vu 
improved the cleansing level from 25% at baseline to 99% after the cleansing was operated and 
in 98% of the subjects the cecum was reached and the procedures completed successfully.  

 
 
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Lastly, subjects to be enrolled to this study shall be eligible to colonoscopy, thus the risks 
detailed above covers all the population intended to participate in the study.  
Considering the residual risks and the potential and the risk against benefit assessment, it can be 
concluded that the system may offer potential benefit to the subjects along with no significant 
risk increase. 
7.2 
Anticipated Risks Associated with bowel preparation agents 
The Bowel preparation agent used in this study follows the current practice used in US hospitals. 
The main anticipated risks associated with the bowel preparation agents including nausea with or 
without vomiting, abdominal pain and dehydration. 
7.3 
Residual risk associated with the study device  
The residual risk is the risk remaining after the risk controls have been implemented.  
The residual risk is evaluated according to the following: 
• Acceptable Residual risk includes all RPN ≤ 9.  
• Risks rated 10-16 will be acceptable if the risk benefit ratio justifies it. 
All risks of using Pure-Vu were mitigated by risk management process according to EN ISO 
14971:2012.  
The mitigation to the risks associated with the investigational device includes but is not limited 
to the followings: 
• Smooth head shape that contains lumens for cleansing jets and evacuation. The lumens' 
sizes were optimized to ensure the safety of the subjects along with effective cleansing.  
• The Pure-Vu Oversleeves are made from a flexible and low friction material to allow 
ease of advancement through the colon and to minimize any impact to the steering angle 
of the colonoscope. 

 
 
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• Hydrophilic coating at the distal 28cm of the outer sleeve to create a lubricious surface to 
aid in insertion and advancement.  
• Cleansing procedure can be operated in 3 modes (low, medium, high), where the 
physician can control the intensity of cleansing jets to ensure effective cleansing.  
The potential residual risk following the mitigations are all acceptable (for more details please 
refer to "Risk analysis report"). 
7.4 
Potential Benefits to the Subject 
The potential benefits of the Pure-Vu System are utilization of a cleaning technology that may 
improve the standard colonoscopy visualization, reduce reliance on subject pre-procedure colon 
preparation for ensuring high quality colonoscopy, increase the subject compliance to 
colonoscopy procedure and reduce the need for repeated colonoscopies required due to 
insufficient colon preparation, these consequently may reduce pain, discomfort, risk and cost. 
Considering the residual risks and the risk against benefit assessment, it can be concluded that 
the system may offer potential benefit to the subjects along with no significant risk increase 
compared to the standard of care procedure. 
8.0 Study Objectives  
8.1 
Primary objective  
To evaluate the improvement of bowel cleansing after Pure-Vu use in hospitalized subjects 
which may increase the likelihood of a successful colonoscopy examination.  
8.2 
Secondary objectives: 
o To evaluate the safety related to the Pure-Vu System. 
o To evaluate the potential improvement in hospitalized subjects’ outcomes when using the 
Pure-Vu System. 

 
 
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9.0 Study Endpoints  
9.1 
Primary endpoints  
The rate of improved cleansing level per segment will be evaluated by the BBPS (1) scoring 
index pre- and post- Pure-Vu use during a colonoscopy examination. 
9.2 
Secondary endpoints  
The following endpoints will be evaluated per study arm:  
o Type, incidence, severity, and duration of adverse events. 
o Cecum intubation rate 
o Proportion of subjects with successful colonoscopy with Pure-Vu for the intended 
indication in the first attempt. 
10.0 Study Design 
This multicenter, prospective, single arm study will include up to 100 subjects (up to 35 subjects 
per site), aimed at evaluating the performance of the Pure-Vu System in cleansing hospitalized 
subjects' colon who are indicated for standard colonoscopy procedure.  Subjects will be enrolled 
at up to 6 clinical sites in the United States and Europe 
 Subject consent will be obtained 
 Prior to the colonoscopy procedure, the nurse or study coordinator will be asked to 
complete a questionnaire including the subjects' bowel preparation type, volume, duration 
and overall preparation condition.  
 The subject will undergo the colonoscopy procedure with the Pure-Vu system.  
 In case of inadequate bowel preparation defined as BBPS score less than 2 in at least one 
of the colon segments prior Pure-Vu use, the physician will complete a questionnaire on 
the patient’s management standard of care assuming the absence of Pure-Vu.   

 
 
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 Following the colonoscopy with Pure-Vu a follow-up evaluation will be conducted at 48 
hours (± 48 hours) to assess subject’s well-being and capture any adverse events. If the 
subject is no longer hospitalized, the follow up will be conducted by a telephone call. 
Study Flowchart  
 
 
 
 
 
 
 
 
 
 
 
       
 
 
 
 
 
Adequate                                                                             Inadequate 
 
           Bowel preparation                  
 
 
         Bowel preparation 
 
 
 
 
 
 
 
 
 
 
Selected Study 
Population 
Bowel Preparation as 
standard of care 
Fill out patient 
cleansing condition 
 
Fill-in patient 
management questionnaire 
Colonoscopy with Pure-
Vu System 
Capture Procedure 
Outcomes 

 
 
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11.0 Subject Selection and Enrollment 
After being informed of the study, the subject will sign the sites’ designated IRB approved 
informed consent form (ICF).  Enrollment of up to 100 subjects is planned.  
Subjects’ participation in the study will last approximately 3 days, including the procedure day, 
and the follow up period. 
Subjects will be considered for the study if they meet the specific inclusion/exclusion criteria. 
The criteria for enrollment must be followed explicitly. 
11.1 Inclusion Criteria 
1. Hospitalized subjects who are indicated for a screening, diagnostic, surveillance or 
therapeutic colonoscopy  
2. Subjects’ age > 22 years 
3. Subject has signed the informed consent 
11.2 Exclusion Criteria 
1. Subjects with known Inflammatory Bowel Disease and / or active Colitis 
2. Subjects with active diverticulitis 
3. Subjects with known or detected (during colonoscopy) bowel obstruction 
4. Subjects with ascites Child Pugh C  
5. Subjects who are 30 days post-transplant 
6. Subjects under active IV inotropic medications 
7. Subjects with LVAD 
8. Subjects with known coagulation disorder (INR ≥ 2 or platelets <50,000) 
9. Subjects with medical and/or hemodynamic instability.  
10. Pregnancy (as stated by Subject) or breast feeding 

 
 
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11. Subjects with altered mental status/inability to provide informed consent 
12. Subjects who have participated in another interventional clinical study in the last 2 months 
11.3 Withdrawal Criteria 
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. 
 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 investigational procedures 
The sponsor must be informed in each withdrawal case. The reason for withdrawal must be 
recorded in the CRF and in the subject’s study file. 
11.4 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 procedures and practices at his/her institution. 
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, case report form 
(CRF) completion, and Good Clinical Practice (GCP), as well as the device and system 
(including procedural use, device characteristics, shelf life and storage requirements, warnings, 
and precautions). 

 
 
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12.0 Study Procedures 
12.1 Screening and Informed Consent 
A screening/baseline assessment will be performed prior to the scheduled Pure-Vu procedure to 
ensure subject’s eligibility and willingness to participate in the study.  
At the screening visit, subjects will be approached to obtain written informed consent prior to 
any study specific procedures being performed. The purpose of the study and the benefits and 
risks of the procedures will be explained to the subject and the consent process must 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 the study at any time. Subjects 
will be given the opportunity to ask the investigator questions so that they are adequately 
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. 
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. 
The following assessments will be performed prior to the scheduled procedure and the results 
recorded on the appropriate subject CRFs: 
• Verification of eligibility criteria and subject risk per guidelines  
• Demographics (age, gender, height, weight) 
• Surgical and medical history (prior abdominal surgery, GI symptoms) 
• General medical history will be assessed based on the subject’s clinical condition 
Subjects who were found to be ineligible for the study following signature of the Informed 
Consent Form will be withdrawn from the study and no further follow up will be performed. 

 
 
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12.2 Randomization 
NA –Single study arm 
12.3 Screen Failures 
A subject is considered enrolled in the study when the ICF is signed.  Only subjects who undergo 
the colonoscopy procedure with Pure Vu will be followed. Subjects who provide study consent, 
but then are determined to be ineligible will be considered screening failures and will not require 
additional study follow-up. The reason for the screening failure will be clearly documented, the 
Subject “Enrollment and Visit Log” will be completed and the subject eligibility section in visit 
1 as well as a "Study Completion" form will be completed in the CRF.  
12.4 Colon Preparation 
As standard practice in the hospitalized population setting, bowel preparation is prescribed for 
individuals undergoing a colonoscopy procedure.  The typical and recommended bowel prep is 
the 4 Liters of GoLytly as a split dose.  Although this bowel prep is widely prescribed, it is not a 
requirement that the subject completes the bowel prep prior to the colonoscopy procedure for the 
study. 
12.5 Colonoscopy procedure  
Pre-Examination Procedures 
• Verify eligibility checked and informed consent was obtained after explaining all risks, 
benefits, and alternatives to the subject. 
• Verify that the study coordinator/nurse has completed the questionnaire regarding the 
subject’s bowel cleansing condition. 
• Verify all background/clinical information, demographic and medical history was 
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• Verify all connections and assembles are properly attached (see Instructions for Use)  
• Verify device works properly (see Instructions for Use)  
• Place and prepare the subject for the colonoscopy procedure. 
Colonoscopy Procedures 
The insertion during the colonoscopy procedure will be performed by the clinical study 
investigator(s), experienced in GI endoscopy according to local standard of care. The withdrawal 
part of the colonoscopy procedure will be performed as per the clinical investigator(s) direction. 
Physicians in training (residents, fellows) and physician assistants may assist the Study 
Investigator in any aspect of this part of the procedure as per standard procedures and practices at 
his/her institution. In cases where upper endoscopy is planned, it will be conducted per the 
physician’s discretion.  Anesthesia will be applied as well per the standard of care. In order to 
ensure correct operation of the Pure-Vu System a Motus GI representative may attend the 
procedure.  Pure-Vu System operation is described in the Instruction for Use.   
 
The colon preparation level for each colorectal segment (ascending, transverse and descending) 
before the cleansing operation during the insertion phase will be evaluated using the BBPS 
scoring index (Appendix B). 
In case of inadequate bowel preparation defined as  BBPS less than 2 in at least one of the colon 
segments prior Pure-Vu use, the physician will complete a questionnaire as it relates to the 
subjects management standard of care assuming absence of the Pure-Vu System.  
Once the procedure is completed, relevant data will be recorded on the CRF in addition, findings, 
diagnosis as well as Physician questionnaire will be recorded/completed.  
The colonoscopy examination with the Pure-Vu will be recorded on digital media. Only the 
subject study ID and initials should appear in the recorded video. 
The cecum will be documented in a picture, if applicable. 

 
 
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All optical colonoscopy still pictures will be saved in a digital format. Quality copies of the 
pictures taken during optical colonoscopy will be provided to the sponsor and the optical 
colonoscopy report will be reviewed as part of the monitoring process. 
These videos and pictures will be archived and may be used in future analyses to, for example, 
provide further information about observed lesions or to assess study quality. 
Specific situations occurring during colonoscopy 
• If the attempt to reach the cecum is failed, the investigator shall perform the procedure 
with a pediatric or any other colonoscope he/she may choose without Pure-Vu. The 
subject will complete the study as planned.  
• If a medical condition requiring treatment is detected during colonoscopy, the subject 
will be treated as per the standard care.  
Post-Examination Follow-up 
Subjects will be transferred to 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 will be 
conducted 2 business days (+/- 48 hours) after the procedure to verify that there has been no 
change in their well-being. Any AE will be documented in the CRF.  
Before a subject is considered “lost to follow-up”, there must be at least two documented 
attempts to contact the subject. 
13.0 Statistical Analysis  
13.1 Sample Size Determination 
This is a pilot study that will include up to 100 subjects; no statistical considerations were made 
to determine the sample size. 

 
 
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13.2 Description of statistical methods 
Basic demographic and other baseline characteristics will be collected and analyzed for all 
subjects.  Summary statistics (mean, standard deviation, median, minimum and maximum for 
quantitative variables) will be presented for the total study population. Frequency tables for 
qualitative data will be provided.    
Any deviation from specified statistical plan will be in addition to “per protocol” analysis and will 
be reported as such. Intent-To-Treat and Post-hoc analysis will be conducted according to the 
existing data gathered, if necessary.   
13.3 Primary Endpoint Analysis 
The primary endpoint is improving the bowel cleansing level, as determined by BBPS scoring 
index, assessed per segment (cecum and ascending / transverse / descending, sigmoid and 
rectum).  
The primary statistical hypothesis is that the cleansing level post Pure-Vu procedure will be 
significantly improved as compared to the cleansing level pre procedure (prior the Pure-Vu use). 
The primary performance assessment will be based on data from all colon segments observed 
during the colonoscopy procedure.  
The count and percentage of segments and subjects with improved BBPS after the Pure-Vu 
cleansing procedure will be presented together with 95% confidence intervals. 
13.4 Secondary Endpoints Analysis 
13.4.1 Safety Analysis 
The secondary endpoint is to evaluate the device related adverse event and the overall adverse 
events rate.  The safety analysis set will consist of all subjects who were enrolled into the study. 

 
 
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Individual listings of adverse events including type, reported term, seriousness, duration, 
relationship to the study device, severity and the adverse events outcome will be provided for the 
total population.  AEs will be summarized using frequency counts and percentages. 
13.4.2 Efficacy Analysis 
Cecal Intubation Rate 
The count and percentage of subjects for which cecum could be reached by the colonoscope with 
the Pure-Vu will be presented together with 95% confidence intervals. 
Proportion of subjects with successful colonoscopy at first attempt 
Successful colonoscopy at first attempt is defined as complete procedure conducted as scheduled 
for the intended indication. 
Frequency counts, percentages, and 95% confidence intervals will be provided.  In addition, the 
above proportion will be compared vs. the proportion of subjects that would have underwent a 
complete procedure at first attempt assuming absence of the Pure-Vu System (as per the data to be 
captured by the Patient Management Direction ).  Chi-square or Fisher’s exact test, as appropriate, 
will be performed to evaluate the difference between the two clinical set-ups. 
13.5 Analysis Populations 
Cases withdrawn prior to the Pure-Vu procedure and those with technical failures will be excluded 
from the primary analysis. Cases with failure to reach the desired colon segment per the intended 
indication, which cannot be conducted with Pure-Vu, will be excluded from the primary analysis.  
All subjects who have the Pure-Vu inserted will be included in the safety analysis. 
Individual listings of withdrawal / technical failure including descriptive information will be 
provided. 

 
 
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13.6 Interim Analyses 
An interim analysis is planned after procedure completion of 45 subjects aims to verify the 
recruitment pace and the study flow. 
14.0 Adverse Events (AEs) and Complications 
AE and AE subcategories are defined per ISO14155:2011, as described below. 
14.1 Adverse Event (AE) 
An AE is any untoward medical occurrence, unintended disease or injury, or untoward clinical 
signs (including abnormal laboratory findings) in subjects, whether or not related to the 
investigational medical device.  
This definition includes events related to the investigational medical device or the comparator and 
the procedures involved.  
AEs will be collected starting from the time subject is enrolled until the follow-up period is 
completed. 
14.2 Serious Adverse Event (SAE) 
A Serious AE (SAE) is an AE that has 
a) Led to death, 
b) Led to serious deterioration in the health of the subject, that either resulted in 
1) A life-threatening illness or injury, or 
2) A permanent impairment of a body structure or a body function, or 
3) In-patient or prolonged hospitalization, or 
4) Medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 

 
 
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c) Led to fetal distress, fetal death or a congenital abnormality or birth defect 
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical 
investigational plan, without serious deterioration in health, is not considered an SAE. 
Some important medical events, although they 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.   
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. 
Disability means a substantial disruption of a person’s ability to conduct normal life’s functions.  
14.3 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. 
14.4 Serious Adverse Device Effect (SADE) 
 
A Serious Adverse Device Effect is an adverse device effect that has resulted in any of the 
consequences characteristic of an SAE. 

 
 
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14.5 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.  
14.6 Adverse Event Severity Classification 
 Severity will be defined according to the following criteria: 
An AE can be classified as severe and not deemed a SAE. Similarly, a SAE is not automatically 
severe in nature. 
14.7 Adverse Event Relationship Classification 
Relationship to study product administration will be determined as follows: 
• No Relationship: No relationship between the AE and the administration of study 
treatment 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 treatment and follows a known response pattern to the study 
treatment 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 treatment; follows a known response pattern to the study 
treatment; and cannot be reasonably explained by the known characteristics of the 
participant’s clinical state or by other therapies. 
Mild 
Awareness of event, but easily tolerated 
Moderate 
Discomfort enough to cause some interference with activities of daily living (ADL) 
Severe 
Incapacitating, with an inability to perform ADL 

 
 
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• Definite Relationship: An AE that follows a plausible temporal sequence from 
administration of the study treatment and follows a known response pattern to the study 
treatment. The reaction cannot be reasonably explained by the known characteristics of 
the subject’s clinical state or other modes of therapy 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 treatment. 
14.8 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. 
• Continuing: The event is ongoing at the end of the study. 
• Death: This event is determined to be the cause of death. 
14.9 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 to be reported as AEs. However, if there is an AE that results from a 
device deficiency, that specific event would be recorded on the appropriate CRF. 

 
 
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14.10 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 
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 CRF 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 AEs observed during the course of this study, regardless of severity or relationship to the 
investigational device will be recorded on the appropriate CRF. 
14.11 Reporting Responsibilities 
An investigator shall submit to the sponsor and to the reviewing IRB a report of any SAEs, ADEs, 
SADEs, 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.  
A sponsor who conducts an evaluation of an unanticipated adverse device effect under 21 CFR 
Part 812.46(b) shall report the results of such evaluation to FDA and to all reviewing IRB's and 
participating investigators within 10 working days after the sponsor first receives notice of the 
effect. Thereafter the sponsor shall submit such additional reports concerning the effect as FDA 
requests (21 CFR Part 812.150). 

 
 
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15.0 Ethics and Compliance 
15.1 Statement of Compliance 
This clinical investigation will be conducted in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki, ISO 14155:2011 (Clinical Investigation of Medical 
Devices for Human Subjects – Good Clinical Practice), ICH-GCP, and any regional or national 
regulations, as appropriate. 
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. 
15.2 Protocol Compliance 
No changes to the 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 
Investigational Plan 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, but in no event later than 5 
working days after the emergency has occurred. Except in such an emergency, prior written 
approval by Motus GI is required for changes in or deviations from the Plan. 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 Investigational Plan 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. 

 
 
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15.3 Institutional Review Board (IRB)/Ethics Committee (EC) 
Documented approval from the appropriate Institutional Review Board (IRB) and Ethics 
Committee (EC) 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/EC approval must be obtained. The IRB/EC must supply to the sponsor a 
list of the IRB membership and a statement to confirm that the IRB/EC is organized and operates 
according to GCP and applicable laws and regulations. 
15.4 Subject Informed Consent 
Prior to the beginning of the trial, the investigator must have the IRB/EC written approval of the 
ICF and any other written information to be provided to subjects. The written approval of the 
IRB/EC 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) and must adhere to GCP and to the ethical principles originating in the 
Declaration of Helsinki. Written 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. 
15.5 Insurance 
All subjects participating in the trial will have insurance coverage by the Sponsor, which is in 
line with applicable local laws. 
15.6 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.  

 
 
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Subject names will be kept confidential. Only the subject number and initials will be recorded in 
the CRF, and if the subject name appears on any other document, it must be obliterated. In cases 
were the local law does not allow using the subject initials serial number will be appointed (e.g. 
AAA, BBB). 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/EC 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. 
15.7 Use of Data and Publications 
Information regarding the study and study data will be made available via publication on 
clintrials.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.  
The investigator, 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 

 
 
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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. 
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.  
16.0 Monitoring Procedures 
Site visits will be conducted by an authorized Motus GI representative to inspect study data, 
subjects’ medical records, and CRFs in accordance with current ICH GCPs and the respective 
local and national government regulations and guidelines (if applicable).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 CRFs, IRB 
decisions, and Investigator, clinical site records, and facilities relevant to this study at regular 
intervals throughout the study per the monitoring plan. Additionally, subject charts and clinical 
records will be requested and reviewed so that protocol adherence and source documentation can 
be verified. The accuracy and quality of the data obtained from the investigator and maintained 
by Motus GI will be confirmed through a structured program of clinical field auditing and 
internal review detailed in the monitoring plan. In instances where data protection regulations 
prohibit the direct examination of hospital records by the study Sponsor or designee(s), the 

 
 
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Investigator will provide another mechanism of access to allow source data verification by the 
Sponsor. Monitoring may be performed with in person visits or remotely, when applicable.  
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 devices. 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/EC, the monitor will report to the Sponsor and take such steps 
necessary to promptly secure compliance. If compliance cannot be secured, device shipments to 
the investigator may be discontinued and the investigator’s participation in the investigation 
terminated. The monitor shall also require such an investigator to dispose of or return the device, 
unless this action would jeopardize the rights, safety, or welfare of a subject.  
16.1 Data Collection and Processing 
This study will utilize a Case Report Form (CRFs). All data requested on the CRFs are 
considered required. Data points not collected and/or recorded will be considered deviations 
unless otherwise specified. 
The Principal Investigator must ensure the accuracy and completeness of the recorded data and 
then provide his/her signature on the appropriate CRFs and will be documented in compliance 
with local regulations. Changes to data previously submitted to the sponsor will require a new 
signature by the Investigator to acknowledge/approve the changes. 
Data review will be performed to identify possible data discrepancies and queries will be created 
and issued to the site for correction. The site staff and site investigator will be responsible for 
resolving all data queries.  

 
 
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17.0 Study Supplies and Device Accountability 
17.1 Packaging 
The Pure Vu disposables are composed of biocompatible plastic parts 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 9 months. 
17.2 Labeling 
All packages are labeled in conformance to Motus GI Packaging Best Practice, which are 
applicable to Single Use, Limited Shelf Life, Lot produced items. Examples of the main system 
and packaging label as well as operation instructions, precautions and warnings are defined in 
the Instructions For Use. 
17.3 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 and WS connector, the following information should be 
recorded: 
• The subject study number  

 
 
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• Date dispensed  
• Oversleeve Lot Number 
• Work Station Connector Lot Number  
At the termination of the study, all unused study material must be returned with the 
corresponding documentation as directed by Motus GI. 
17.4 Retention of Records 
All source documents and CRFs will be kept for a period of no less than five years after the later 
of the following dates: the date of which the study is terminated or completed or; the date that the 
records are no longer required supporting marketing applications. 
17.5 Study Completion/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/ECs, 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 on the appropriate CRF. 
The appropriate IRB/EC 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/EC and/or regulatory authority. 
 
 
 

 
 
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18.0 General Information 
18.1 Study Contact Information 
Questions should be directed to Clinical Affairs. 
Clinical Affairs 
Hagit Ephrath 
VP of Health Economics, Regulatory and Clinical Affairs 
Motus GI Technologies LTD. 
Keren Ha'yesod 22 3902638 
Tirat Carmel, Israel 
Phone: +972 (73) 3243824 
Mobile: +972 (52) 314-2045 
Email: hagit@motusgi.com  
 
19.0 
References 
 
1. 
Lai E.J. et al.; The Boston Bowel Preparation Scale: A valid and reliable instrument , 
Gastrointestinal Endoscopy ,2009: 69(3 Pt 2): 620–625 
2. 
Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, et al. GLOBOCAN 2012 v1.0, 
Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: 
International Agency for Research on Cancer; 2013.  [cited 2014 July 8]. Available from: 
http://globocan.iarc.fr. 
3. 
Howlader N, Noone AM, Krapcho M, Miller D, Bishop K, Altekruse SF, Kosary CL, Yu M, 
Ruhl J, Tatalovich Z, Mariotto A, Lewis DR, Chen HS, Feuer EJ, Cronin KA (eds). SEER Cancer 
Statistics Review, 1975-2013, National Cancer Institute. Bethesda, 
MD, http://seer.cancer.gov/csr/1975_2013/ based on November 2015 SEER data submission, 
posted to the SEER web site, April 2016. 
4. 
Brenner H, Kloor M, Pox CP. Colorectal cancer. Lancet. 2014 Apr 26;383(9927):1490-502. 
5. 
Yee J, Kim DH, Rosen MP, Lalani T, Carucci LR, Cash BD, et al. ACR Appropriateness Criteria 
Colorectal Cancer Screening. J Am Coll Radiol. 2014 Jun;11(6):543-51. 
6. 
Robert E. Clark, Matthew L. Bechtold, et al; Low-volume polyethylene glycol and bisacodyl for 
bowel preparation prior to colonoscopy: a meta-analysis. Annals of Gastroenterology (2013) 26, 
319-324. 
7.  
Ness RM, Manam R, Hoen H, Chalasani N. Predictors of inadequate 
bowel preparation for colonoscopy. Am J Gastroenterol. 2001; 96: 1797-802. 
 
 

 
 
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20.0 
 Appendixes A: Study Design and Schedule of Assessment 
 
 
Visit 1 
Follow Up 
Days 
0 
2 Business Days 
 (± 48 hours) 
Informed Consent 
X 
 
Eligibility assessment (medical records, BMI, etc.) 
X 
 
Medical History, Concomitant Medications, and 
Demographic details 
X 
 
Assessment of patient’s bowel preparation 
questionnaire  
X 
 
*Assessment of patient’s management Directions 
(filled-in by the physician) 
X 
 
Colonoscopy Procedure 
X 
 
Follow Up 
X  
X 
Adverse Events Reporting 
X 
X 
 
*for subjects with inadequate bowel cleansing level in at least one segment at baseline. 
 
 

 
 
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21.0 
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.