Optimizing the Preparation Regime Prior to Colonoscopy Procedure With Pure-Vu System
Phase: NA
Conditions: Gastrointestinal Diseases, Colorectal Cancer
Sponsor: Motus GI Medical Technologies Ltd

 
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Title Page 
Clinical Investigational Plan (CIP) INFORMATION 
Title: 
Optimizing the Preparation Regime Prior to Colonoscopy Procedure  with 
Pure-Vu System 
CIP Number: 
CL00042 
Version Date: 
December 13, 2017 
Revision: 
1.0 
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 G.I. 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 
Revision Section 
Description of Change 
Reason for Change 
NA 
NA 
NA 
NA 
 
 
 

 
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1.0 Signature Page 
Principal Investigator Signature Page 
Title: 
Optimizing the Preparation Regime Prior to Colonoscopy Procedure  
with Pure-Vu System 
CIP Number: 
CL00042 
Version Date: 
December 13, 2017 
Revision: 
1.0 
 
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 outlined in the Clinical Trial Agreement. 
 
 
________________________    ____________________________    ______________________ 
Name 
Signature 
 
Date 
 
 
 
Sponsor representative signature 
 
________________________          ____________________                ____________________ 
Name 
    Signature 
 
 Date 
 
 

 
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2.0 Table of Contents 
1.0 
Signature Page .................................................................................................................... 2 
2.0 
Table of Contents ................................................................................................................ 3 
3.0 
Protocol Synopsis ................................................................................................................ 7 
4.0 
Acronyms and Definitions ................................................................................................. 11 
5.0 
Introduction ...................................................................................................................... 12 
5.1 
Background .................................................................................................................... 12 
6.0 
Investigational Device ....................................................................................................... 13 
6.1 
General Description........................................................................................................ 13 
6.1.1 
Work Station (WS) ................................................................................................. 15 
6.1.2 
WS Connector ......................................................................................................... 16 
6.1.3 
Ancillary Apparatus ................................................................................................ 16 
6.2 
Pre-clinical data .............................................................................................................. 17 
6.3 
Clinical data to Date ....................................................................................................... 17 
7.0 
Risk/Benefit Analysis ......................................................................................................... 18 
7.1 
Anticipated Risks Associated with Pure-Vu System conjunction with a standard 
colonoscope............................................................................................................................... 18 
7.2 
Anticipated Risks Associated with bowel preparation agents ....................................... 19 
7.3 
Residual risk associated with the investigational device ............................................... 19 
7.4 
Potential Benefits to the Subject .................................................................................... 20 
8.0 
Study Objectives ............................................................................................................... 21 
8.1 
Primary objective ........................................................................................................... 21 
8.2 
Secondary objectives: .................................................................................................... 21 
9.0 
Study Design...................................................................................................................... 21 
Study Flow chart ....................................................................................................................... 22 
9.1 
Primary Endpoint ........................................................................................................... 22 

 
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9.2 
Secondary Endpoints ...................................................................................................... 22 
10.0 
Subject Selection and Enrollment ..................................................................................... 23 
10.1 
Inclusion Criteria ........................................................................................................ 23 
10.2 
Exclusion Criteria ....................................................................................................... 23 
10.3 
Withdrawal Criteria .................................................................................................... 24 
10.4 
Selection of Investigators and Training ...................................................................... 25 
11.0 
Study Procedures .............................................................................................................. 25 
11.1.1 
Screening and Informed Consent (Visit 1) ............................................................. 25 
11.1.2 
Randomization ........................................................................................................ 26 
11.1.3 
Screen Failures ........................................................................................................ 26 
11.1.4 
Colon Preparation ................................................................................................... 27 
11.1.5 
Colonoscopy procedure (Visit 2) ............................................................................ 27 
11.2 
Required Concomitant Medications or Therapies ...................................................... 29 
12.0 
Statistical Analysis ............................................................................................................. 29 
12.1 
Sample Size Determination ........................................................................................ 29 
12.2 
Description of statistical methods............................................................................... 29 
12.3 
Primary Endpoint Hypothesis Analysis ...................................................................... 29 
12.4 
Effectiveness Analyses ............................................................................................... 30 
12.5 
Analysis Populations .................................................................................................. 31 
12.6 
Interim Analyses ......................................................................................................... 31 
12.7 
Potential Limitations................................................................................................... 32 
13.0 
Adverse Events (AEs) and Complications ........................................................................ 32 
13.1 
Adverse Event (AE) .................................................................................................... 32 
13.2 
Serious Adverse Event (SAE) .................................................................................... 32 
13.3 
Adverse Device Effect (ADE) .................................................................................... 33 
13.4 
Serious Adverse Device Effect (SADE) ..................................................................... 33 
13.5 
Unanticipated Serious Adverse Device Effect (USADE) .......................................... 34 
13.6 
Adverse Event Severity Classification ....................................................................... 34 

 
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13.7 
Adverse Event Relationship Classification ................................................................ 34 
13.8 
Adverse Event Outcome Classification ...................................................................... 35 
13.9 
Device Deficiencies .................................................................................................... 35 
13.10 
Adverse Event Recording and Reporting ................................................................... 35 
13.11 
Reporting Responsibilities .......................................................................................... 36 
14.0 
Ethics and Compliance ..................................................................................................... 36 
14.1 
Statement of Compliance ............................................................................................ 36 
14.2 
Protocol Compliance .................................................................................................. 37 
14.3 
Institutional Review Board (IRB)............................................................................... 37 
14.4 
Subject Informed Consent .......................................................................................... 37 
14.5 
Insurance ..................................................................................................................... 38 
14.6 
Confidentiality ............................................................................................................ 38 
14.7 
Use of Data and Publications...................................................................................... 38 
15.0 
Monitoring Procedures...................................................................................................... 39 
15.1 
Data Collection and Processing .................................................................................. 40 
16.0 
Study Supplies and Device Accountability....................................................................... 40 
16.1 
Packaging.................................................................................................................... 40 
16.2 
Labeling ...................................................................................................................... 40 
16.3 
Inventory Control ....................................................................................................... 41 
16.4 
Retention of Records .................................................................................................. 41 
16.5 
Study Completion/Termination of Study ................................................................... 41 
17.0 
General Information .......................................................................................................... 42 
17.1 
Study Contact Information ......................................................................................... 42 
18.0 
References ......................................................................................................................... 43 
19.0 
Appendixes A: Study Design and Schedule of Assessment ............................................. 44 
20.0 
Appendixes B: Bowel Preparation flow chart .................................................................. 45 

 
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20.1 
Appendixes B1: Bowel Preparation for morning procedures ..................................... 45 
20.2 
Appendixes B2: Bowel Preparation for afternoon procedures ................................... 46 
................................................................................................................................................... 46 
21.0 
Appendixes C: Boston Bowel Preparation Scale .............................................................. 47 
22.0 
Appendix D – Patient Diary .............................................................................................. 48 
22.1 
Diet Instructions for morning procedures ................................................................... 48 
22.2 
Diet Instructions for afternoon procedures ................................................................. 49 
22.3 
Meal and Liquids Log................................................................................................. 50 
22.5 
Bowel Movements Log .............................................................................................. 51 
23.0 
Appendix E – Case Report Form (filled-in by the patient) ............................................... 52 
24.0 
Appendix F – Case Report Form (filled-in by the physician) .......................................... 56 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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3.0 Protocol Synopsis 
Study Summary 
Study Purpose 
To determine the optimal bowel preparation regimen for Pure-Vu System 
procedures in patients indicate for colonoscopy procedure. 
Objective 
The  primary  objective of this multicenter, prospective, randomized study is 
to  evaluate the performance of Pure-Vu System in cleansing patients' colon 
who are indicated for a colonoscopy procedure using one of two different 
reduce bowel preparation regimes.in addition, the cecum intubation rate, time 
to cecum, total procedure time, and adverse event will be evaluated. 
Test and  
Comparator 
Procedures 
Prep A   
Prep B  
5 days prior procedure day 
No seedy food 
1 day prior procedure day 
Low residue diet; 
Spilt dose of 15 oz Magnesium 
Citrate + 39 oz of clear liquid 
Spilt dose of 10 oz Magnesium Citrate 
+ 32oz of clear liquid 
Procedure Day 
Clear-liquid diet up to 3 hours prior to the procedure 
Fasting (no food / liquids) start 3 hours prior to procedure time 
*At least 2 liter water per day during the preparation days.  
 

 
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Protocol Number 
CL00042 
Protocol Title 
Optimizing the Preparation Regime Prior to Colonoscopy Procedure  with 
Pure-Vu System Rev 1.0 
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 
Ravit Peled  
Director of Clinical Affairs 
Study Type 
Multicenter, prospective, randomized feasibility study 
Study Product 
Pure-Vu System  
Study Phase 
Post-market 
IDE Number 
K173392 Class II 
Study Location 
United States 
Study Duration 
Study period will last approx. 12 months  
Study Design 
Patients will be randomized to receive one of two bowel preparation 
regimens prior to colonoscopy with Pure-Vu procedure.  
Planned Follow-Up 
Telephone follow-up will be conducted at 2-3 working days post-
procedure to assess subject well-being and capture any adverse 
events. 
Subject Population 
Subjects indicate for colonoscopy procedure 

 
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Planned # of 
Subjects 
Up to 100 subjects  
Planned # of Sites 
Up to 3 clinical sites 
Primary Endpoint 
The rate of adequate cleansing level per patient will be evaluated by 
the BBPS(1) scoring index post the cleansing operation in both study 
arms. 
Secondary Outcomes The following secondary outcomes will be determined : 
 Adverse events 
 Cecal intubation rate 
 Time to Cecum 
 Total procedure time  
Randomization 
Block randomization will be employed for each site to assign 
subjects to one of the two bowel preparation arms (Prep A versus 
Prep B). 
Eligibility Criteria 
Inclusion Criteria 
1. 
Subjects scheduled for colonoscopy procedure 
2. 
Subjects in the age range 22-7 5  years inclusive 
3. 
Subject is willing and able to participate in the study 
procedures and to understand and sign the informed 
consent. 
Exclusion Criteria 
1. 
Patients with active Inflammatory Bowel Disease  
2. 
Patients with known diverticulitis disease or with prior 
incomplete colonoscopy due to diverticular disease 
3. 
Patients with known bowel obstruction 
4. 
Patient with chronic constipation 
5. 
History of prior surgery to colon and/or rectum 

 
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6. 
ASA ≥ III 
7. 
Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on 
medical history) 
8. 
Abnormal Liver enzymes (ALT/AST ≥ 2 times upper 
limits of normal) (based on medical history)  
9. 
Patients taking anticoagulants drugs (excluding aspirin) or 
dual antiplatelet therapy  
10. 
Patients with known coagulation disorder (INR >1.5). 
11. 
Pregnancy (as stated by patient) or breast feeding 
12. 
Patients with altered mental status/inability to provide 
informed consent 
Statistics 
Primary Endpoint 
Analysis 
The primary endpoint is the rate of adequate bowel cleansing level, 
as determined by Boston Bowel Preparation Scale (BBPS), assessed 
per patient in both study arms. 
Chi-square or Fisher’s exact test, as appropriate, will be performed in 
order to compare the proportions of good or excellent cleansing level 
(i.e., BBPS>1 in all colon segments) post cleansing procedure 
between the two study arms. 
Secondary Analyses 
Cecum intubation rate  
Proportion tests (Chi-square or Fisher’s exact) will be performed in 
order to compare between the two preparation procedures cecum 
intubation rate 
Time analysis 
T-tests for continuous variables will be performed in order to evaluated 
the difference between Prep A and Prep B for the following: 
 Total procedure time 

 
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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 
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 
CT 
computed tomography 
 Time to cecum 
Safety analysis 
Individual listings of adverse events including type of device, 
adverse events (reported term) start date, duration, and severity will 
be provided.  
Determination of 
Sample Size 
This is a pilot study that will include up to 100 patients; no statistical 
considerations were made to determine the sample size.  
Interim analyses 
No Interim analysis is planned. 

 
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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 US government regulation, 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).  
Methods for the evaluation of subjects with suspected colonic disease include optical 
colonoscopy (OC) and radiologic imaging such as double contrast barium enema (DCBE) or 
computed tomography (CT) colonoscopy (5). While OC is considered the gold standard, patient 
acceptance rates are low due to perceived discomfort. 
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 in screening colonoscopy 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).  Poor bowel 
preparation prolongs overall screening and procedure time, decreases cecal intubation rates, 

 
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reduces the detection of colorectal neoplasms, increases complication rates and leads to return 
visits for screening which in turn leads to increased costs (7-12) 
Despite the importance of good preparation, up to 25% of patients arrive for colonoscopy with 
inadequate bowel preparation (13) .  
Pure-Vu System enables colon cleansing during standard colonoscopy using a standard 
colonoscope with a length of 1630mm – 1710mm and a diameter between 12.8mm – 13.7mm 
The Oversleeve device, which fits over the colonoscope and 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. 
The current study is designed to evaluate the efficacy of two different reduced preparation 
regimen intended for use with Pure-Vu System. The study objectives are to compare cleansing 
levels, cecum intubation rate, the time to cecum, the total procedure time, and adverse event 
(AE) rates following use of the two different bowel preparation methods in subjects undergoing 
standard colonoscopy.  
6.0 Investigational Device 
6.1 
General Description 
The Pure-Vu System is Food and Drug Administration (FDA) approved device since September 
22, 2016, 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 the nurse 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). 

 
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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 four main functions: 
 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. 
Oversleeve The Oversleeve is mounted on top of the colonoscope and is connected to WS via 
the WS Connector. The Add-on 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. 

 
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 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 
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. 
6.1.2 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 is slide 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. 
6.1.3 Ancillary Apparatus 
The final part of the system are ancillary apparatus to aid the nurse in loading the device on a 
colonoscope.  

 
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 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. 
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 proved to be 
easy to use.   
6.3 
Clinical data to Date 
The latest Pure-Vu System tested in ninety-seven subjects (54% males) from five sites using 
similar protocol. 
Pure-Vu was used in subjects with a partially prepped receiving a colonoscopy for screening, 
diagnostic or surveillance. 
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 patients were excluded from the analysis due to the followings: 

 
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 One patient who had breakfast on day of procedure was excluded from the cleansing 
efficacy and usability analysis due to non-compliance with the pre-procedural prep 
regimen. 
 In one patients the device could not reach beyond the sigmoid colon due to the patient’s 
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 and 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 Oversleeve to a standard colonoscope. 
Hence, diameter is bigger, and the cleansing time may add some minutes to the procedure time. 
a potential risks associated with the participation in the clinical investigation may include a 
repeated colonoscopy procedure as the subjects enrolled to the study are required to undergo a 
limited prep as compared to the preparation given prior to standard colonoscopy procedure. 
The latest Pure-Vu version was tested in an animal study including 35 pigs and in preliminary 
clinical studies including 97 subjects.  

 
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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 patients the cecum was reached and the procedures completed successfully. 
Efficacy results support the study design rationale that decreases the risks associated with the 
preparation without increasing the risk related to incomplete/ repeated colonoscopy procedure. 
Lastly, patients 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 patients along with no significant 
risk increase. 
7.2 
Anticipated Risks Associated with bowel preparation agents 
The Bowel preparation agent used in this study are approved in U.S. 
The main anticipated risks associated with the bowel preparation agents including nausea with or 
without vomiting, abdominal pain and dehydration. 
The preparation in this study is less intensive compared to the standard preparation done prior to 
colonoscopy procedure, thus we expect that the risks related to the preparation agent will be 
similar or even lower than the risks following a standard preparation to colonoscopy procedure. 
Reduction of the bowel preparation regimen will minimize patient discomfort and AEs 
associated with bowel cleansing, and potentially maximize the efficacy of the colonoscopy 
procedure with Pure-Vu System. 
7.3 
Residual risk associated with the investigational 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.  

 
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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' 
size were optimized to ensure the safety of the patients along with effective cleansing.  
 The Pure-Vu Oversleeve are made from a flexible and low friction material to allow ease 
advancement through the colon and to minimize any impact to the steering angle of the 
colonoscope. 
 Hydrophilic coating at the distal 30cm of the outer sleeve to create a lubricious surface to 
allow ease 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 the safety of the patients 
along with 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. 
The reduce bowel preparation required when Pure- Vu System is used as compare to standard 
preparation required prior to colonoscopy procedure without the Pure-Vu System, may increase 
the subject compliance to the colonoscopy procedure and may reduce the patient’s discomfort 
caused by the preparation regimens.  
Considering the residual risks and the risk against benefit assessment, it can be concluded that 
the system may offer potential benefit to the patients along with no significant risk increase 
compared to the standard of care procedure. 

 
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8.0 Study Objectives  
8.1 
Primary objective  
To evaluate the performance of Pure-Vu System in cleansing patients' colon who are indicated 
for a colonoscopy procedure using one of two different bowel preparation regimes. 
8.2 
Secondary objectives: 
o To evaluate the safety related to the Pure-Vu System in both study arms. 
o To evaluate the time to reach the Cecum in Pure-Vu procedures in both study arms. 
o To evaluate the total procedure time with Pure-Vu in both study arms. 
o To evaluate the cecal intubation rate with Pure-Vu in both study arms. 
o To evaluative patients' satisfaction with Pure-Vu procedure in both study arms. 
o To evaluative Pure-Vu user satisfaction with Pure-Vu procedure in both study arms. 
 
9.0 Study Design 
This multicenter, prospective, randomized study will include up to 100 patients (30 patients per 
site and 15 patients per study arm), aimed at evaluating the performance of Pure-Vu System in 
cleansing patients' colon who are indicated for colonoscopy procedure using one of two different 
preparation regimes as detailed below.  
Subjects will be enrolled at up to 10 clinical sites in the United States. Subjects who meet the 
eligibility criteria will be randomly allocated to a given study arm and will be required to follow 
a specific bowel preparation instruction along with a specific prep agent (Bowel preparation 
instructions for morning and afternoon procedures are provided in appendix B1 and B2, 
respectively), as per study arm allocation, starting 5 days prior to the colonoscopy with Pure-Vu.  
Patients will be asked to record and provide their diet and bowel movements in the provided 
diary log at time of their scheduled colonoscopy (Diary log is provided in appendix D). 
In addition patient will be ask to complete a satisfaction questionnaire include feedback on the 
procedure and on specific aspects related to the preparation regime. 
Following the procedure a telephone follow-up will be conducted at 48 hours (± 48 hours) post 
Pure-Vu procedure to assess patient well-being and capture any adverse events.  

 
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Study Flow chart 
 
9.1 
Primary Endpoint 
The primary endpoint is the rate of adequate cleansing level per subject evaluated by the BBPS 
scoring index pre- and post the cleansing operation. 
9.2 
Secondary Endpoints 
The following secondary outcomes will be determined: 
 AEs  

 
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 Rate of procedures where the cecum was visualized. 
 Time to reach the cecum. 
 Total procedure time. 
 User satisfaction will be evaluated by a questionnaire filled-in by the physicians and 
nurses who conduct the procedures and assemble the Pure-Vu System. 
10.0 Subject Selection and Enrollment 
After being informed of the nature of the study, the subject will sign a written informed consent 
form (ICF) that has been approved by the appropriate IRB of the respective clinical site. 
Enrollment of up to 100 subjects is planned.  
Subjects’ participation in the study will last approximately 8 days, including the procedure day, 
five days prior for bowel preparation, 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. 
Enrollment completion is expected to take place up to 12 months following IRB approval of the 
study. 
10.1 Inclusion Criteria 
1. Subjects scheduled for colonoscopy procedure 
2. Subjects in the age range of 22-75 years inclusive 
3. Subject is willing and able to participate in the study procedures and to understand and 
sign the informed consent. 
10.2 Exclusion Criteria 
1. Patients with active Inflammatory Bowel Disease  
2. Patients with known diverticulitis disease or with prior incomplete colonoscopy due to 
diverticular disease 

 
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3. Patients with known bowel obstruction 
4. Patient with chronic constipation 
5. History of prior surgery to colon and/or rectum 
6. ASA ≥ III 
7. Renal insufficiency (Creatinine ≥ 1.5mg /dL) (based on medical history) 
8. Abnormal Liver enzymes (ALT/AST ≥ 2 times upper limits of normal) (based on medical 
history)  
9. Patients taking anticoagulants drugs (excluding aspirin) or dual antiplatelet therapy  
10. Patients with known coagulation disorder (INR >1.5). 
11. Pregnancy (as stated by patient) or breast feeding 
12. Patients with altered mental status/inability to provide informed consent 
10.3 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 
 
Subject noncompliant with visits 
 
At the specific reasonable request of the sponsor 
The sponsor must be informed in each withdrawal case. The reason for withdrawal must be 
recorded in the CRF and in the patient file. 

 
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10.4 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). 
11.0 Study Procedures 
11.1.1 Screening and Informed Consent (Visit 1) 
Subjects participating in the study may be recruited from investigator's patients’ pool.  
A screening/baseline visit will be performed within 30 days prior to the scheduled Pure-Vu 
procedure to assess preoperative eligibility. In the event that the screening and eligibility 
assessment takes place more than 30 days prior to the planned procedure date, the investigator 
should contact the subject prior to the procedure date to assure there is no change in the subject’s 
medical condition. 
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 record. 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. 

 
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The following assessments will be performed within 30 days 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 
Recruitment visit: 
Patients who meet the eligibility criteria will be screened for study participation and will be 
randomly allocated to a given study arm at a baseline visit. Patients who are eligible for the study 
will be required to follow a specific bowel preparation instruction along with a specific prep agent, 
(Detailed instructions of the study Bowel preparations are provided in appendix B1 and B2) as 
per study arm allocation, starting 5 days prior to the colonoscopy with Pure-Vu.  Subject diaries 
are provided to the subject at visit 1 to be and will be filled by the subjects during the preparation 
phase. This will include diet and bowel movement information (diary log is provided in appendix 
D). The subject is instructed to bring the diary with him/her to the scheduled colonoscopy. 
In addition patient satisfaction questionnaire will be provide include feedback on the procedure 
and on specific aspects related to the preparation regime.  
11.1.2 Randomization 
Randomization in blocks will be applied for each site to allocate patients to one of two different 
bowel preparation regimens (Prep A versus Prep B). The study will utilize randomization in 
blocks using the standard envelope procedure, which will be applied in order to allocate patients 
into two arms: 
 Group 1 - Will go through the Prep A procedure 
 Group 2 - Will go through the Prep B procedure 
The site randomization plan will be provided to the study coordinator prior the study start. No 
blinding is applicable in this study. 
11.1.3 Screen Failures 
A subject is considered enrolled in the study when the ICF is signed. Only subjects who receive 
study-assigned procedures will be followed. Subjects who provide study consent, but then are 
determined to be ineligible prior to randomization will be considered screening failures and will 

 
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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.  
11.1.4 Colon Preparation 
Subjects will be instructed to follow a detailed dietary and colon preparation regimen prior to the 
procedure day. All colon preparation products will be standard colon cleansing products 
approved by the FDA. 
Patients will be randomized to one of two bowel preparation regimens (instruction for bowel 
preparation for morning and afternoon procedures are provided in appendix B1 and B2). 
Subjects will keep a timed diary of key preparation steps and bowel activity, in addition 
questions about the patients satisfaction from the bowel preparation regime and diet instruction 
will be captured (Appendix D).  
11.1.5 Colonoscopy procedure (Visit 2) 
Pre-Examination Procedures 
 Verify eligibility checked and informed consent was obtained after explaining all risks, 
benefits, and alternatives to the candidate. 
 Verify that the research assistant has collected completed diaries from the subject. 
 Verify all background/clinical information, demographic and medical history was 
documented 
Note: Subjects that did not take the bowel preparation or failed to complete the bowel 
preparation will not undergo the procedure and will be excluded from the study.   
 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 procedure as per standard colonoscopy. 
 Perform a digital rectal exam as per standard colonoscopy, evaluate the adequate level of 
the preparation and start the colonoscopy procedure with the Pure-Vu System as per 
standard of care. 
Pre-Examination Procedures 
The procedure will be performed by the clinical investigator(s), experienced in GI endoscopy 
according to local standard of care. Anesthesia will be applied as well per the standard of care. In 

 
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order to ensure correct operation of the Pure-Vu System a Motus GI representative may attend 
the procedure.  Using the Pure-Vu, requires specific training with the device that will be 
provided by the sponsor prior to the study. Pure-Vu System operation is described in the 
Instruction for Use.   
Colonoscopy Procedures 
The colon preparation level for each colorectal segment (ascending, transverse and descending) 
before the cleansing operation during the insertion phase and post the cleansing operation during 
withdrawal will be evaluated using the BBPS scoring index (Appendix C). 
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 VCR or DVD. Only the 
subject study ID and initials should appear in the recorded video. 
The cecum will be documented in a picture. 
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 with the optical 
colonoscopy report. 
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 the 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 standard colonoscopy protocol. 
Subjects will be contacted by phone 2 working days after the procedure to verify that there has 
been no change in their well-being. Any AE will be documented in the CRF.  
In addition questions about the patients’ satisfaction with the Pure-Vu procedure will be 
completed.   

 
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Before a subject is considered “lost to follow-up”, there must be at least two documented 
attempts to contact the subject.   
11.2 Required Concomitant Medications or Therapies 
All the medications used in this study are FDA approved, Commercial off-the-shelf products. 
 
12.0 Statistical Analysis  
12.1 Sample Size Determination 
This is a pilot study that will include up to 100 patients; no statistical considerations were made to 
determine the sample size. 
12.2 Description of statistical methods 
Basic demographic and other baseline characteristics will be collected and analyzed for all 
patients.  Summary statistics (arithmetic 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.   
In addition, in cases of an incomplete procedure (i.e., the entire colon is not visualized); the 
overall BBPS per patient will be evaluated based on the colon segments that were visualized.  
12.3 Primary Endpoint Hypothesis Analysis 
The primary endpoint is the rate of adequate bowel cleansing level after the use of the Pure- Vu.  
The rate of adequate cleansing level in each colon segment before and after use of Pure-Vu will 
be evaluated using the Boston Bowel Preparation Scale (BBPS). 
A score of 0 - 3 will be given to each of the 3 segments of the colon (Descending, Transverse 
and Ascending). 

 
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BBPS scores will be rated by the endoscopist, on the basis of three segment scores summed for 
maximum score of 9, where: 
 0 = unprepared 
 9 = completely clean (in completed to Cecum procedures) 
An adequate cleansing procedure is defined as when all 3 colon segments are graded as 2 or 3. 
Chi-square or Fisher’s exact test, as appropriate, will be performed in order to compare 
proportions of good or excellent cleansing level between the two preparation procedures.  
12.4 Effectiveness Analyses 
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 patients who were enrolled into the study. 
Individual listings of adverse events including type of device, adverse events (reported term), 
seriousness, duration, relationship to the study device, severity and the adverse events outcome 
will be provided for the total population and per study arm.  AEs will be summarized using 
frequency counts and percentages per study arm. 
Cecum intubation rate  
Completion of colonoscopy with the Pure-Vu System is defined from insertion of colonoscope to 
visualization of the cecum.  Cecal intubation will be evaluated by the percent of colonoscopy 
procedures that reached the cecum. 
Proportion (Chi-square or Fisher’s exact) tests will be performed in order to compare between 
the two preparation procedures for the following endpoint based on binary measure. 
In addition, frequency counts, percentages, and 95% confidence intervals will be provided. 
Time analysis 
T-tests for continuous variables will be performed in order to evaluate the difference between the 
two preparation procedures for the following endpoints: 
 Time to Cecum- defined as the duration from colonoscope insertion to visualization of 
the cecum. 

 
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 Total Procedure time- defined as the time from colonoscope insertion to removal. (guide: 
>6mintues withdrawal time) 
These endpoints will be summarized using descriptive statistics, including number of subjects, 
mean, median, standard deviation, minimum, and maximum. 
Patient Satisfaction  
Patient satisfaction will be evaluated by a questionnaire (Appendix E). The patient will be asked 
to fill-in a questionnaire and include their feedback on the procedure including specific aspects 
related to the preparation regime. 
Patient satisfaction will be summarized in a table via descriptive statistics by data type. Chi-
square or Fisher’s exact test, as appropriate, will be performed in order to compare the patient 
satisfaction between the two study arms. 
User Satisfaction  
User satisfaction will be evaluated by a questionnaire (Appendix F). The physicians who conduct 
the procedures will be asked to answer questions related to usability and efficacy of Pure-Vu. 
User satisfaction will be summarized in a table via descriptive statistics by data type. Chi-square 
or Fisher’s exact test, as appropriate, will be performed in order to compare the user satisfaction 
between the two study arms. 
12.5 Analysis Populations 
Cases withdrawn prior to the Pure-Vu procedure and those with technical failure will be 
excluded from the efficacy analysis. All patients who undergo bowel preparation will be 
included in the safety analysis. 
Individual listings of withdrawal / failure including descriptive information will be provided. 
In addition, in cases of incomplete procedure (i.e., the entire colon is not visualized); the overall 
BBPS per patient will be evaluated based on the colon segments that were visualized. 
12.6 Interim Analyses 
No interim analysis is planned in this study. 

 
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12.7 Potential Limitations 
Several potential limitations of the study are acknowledged: 
 The sample size is not statistically powered for this feasibility study. While this may limit 
the study interpretation, the study objective is to evaluate whether Prep B will tend to 
have better outcomes compared to Prep A in order to inform future clinical research 
studies. 
 Because this study uses a standard-risk cohort, the result may not be generalizable to 
high-risk cohorts. 
 
13.0 Adverse Events (AEs) and Complications 
AE and AE subcategories are defined per ISO14155:2011, as described below. 
13.1 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. 
13.2 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 

 
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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, 
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.  
13.3 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. 
13.4 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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13.5 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.  
13.6 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. 
13.7 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. 
 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. 
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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 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. 
13.8 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. 
13.9 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. 
13.10 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: 

 
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 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. 
13.11 Reporting Responsibilities 
An investigator shall submit to the sponsor and to the reviewing IRB a report of any 
unanticipated 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 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). 
14.0 Ethics and Compliance 
14.1 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. 

 
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14.2 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. 
14.3 Institutional Review Board (IRB) 
Documented approval from the appropriate Institutional Review Board (IRB) 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. 
14.4 Subject Informed Consent 
A core information and consent form will be provided. Prior to the beginning of the trial, the 
investigator must have the IRB written approval/favorable opinion of the written ICF and any 
other written information to be provided to subjects. The written approval of the IRB together 
with the approved subject information/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. 

 
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14.5 Insurance 
All subjects participating in the trial will have insurance coverage by the Sponsor, which is in 
line with applicable local laws. 
14.6 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.  
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 low 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 
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. 
14.7 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 

 
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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. 
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.  
15.0 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 
Investigator will cooperate in a system of source data verification with 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 

 
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imposed by the reviewing IRB, 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.  
15.1 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. 
Visual and/or computer data review will be performed to identify possible data discrepancies. 
Manual and/or automatic queries will be created and will be issued to the site for appropriate 
response. The site staff will be responsible for resolving all queries in the database. 
16.0 Study Supplies and Device Accountability 
16.1 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. 
16.2 Labeling 
 All equipment associated with the clinical trial will be identified with visible markings stating 
“Exclusively for clinical investigation only”.  
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 

 
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and packaging label as well as operation instructions, precautions and warnings are defined in 
the “Instructions For Use”. 
16.3 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 conducted under the Regulatory Binder at 
each site and will be monitored by the site’s clinical research associate (CRA). 
In case of technical failure, the site will approach the technical support team which will help 
solve the problem and will notify the site’s CRA.  
For each dispensed Pure-Vu Oversleeve, the following information should be recorded: 
 The subject study number  
 Date dispensed  
 Disposables' ID number  
At the termination of the study, all unused study material must be returned with the 
corresponding documentation as directed by Motus GI. 
16.4 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. 
16.5 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, 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 

 
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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 eCRF. 
The appropriate ethics committees 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 ethics committee and/or regulatory authority. 
 
17.0 General Information 
17.1 Study Contact Information 
Questions should be directed to Clinical Affairs. 
Clinical Affairs 
Ravit Peled 
Director of Clinical Affairs 
Motus GI Technologies LTD. 
Keren Ha'yesod 22 3902638 
Tirat Carmel, Israel 
Phone: +972 (73) 3243823 ext:203 
Mobile: +972 (52) 614-5354 
Email: Ravit@motusgi.com  
 
 
 
 
 
 
 

 
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18.0 
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. 
Ju Sung Sim and Ja Seol Koo; Predictors of Inadequate Bowel Preparation and Salvage Options 
on Colonoscopy. Clinical Endoscopy. 2016 Jul; 49(4): 346–349 
8. 
Belsey J, Epstein O, Heresbach D. Systematic review: oral bowel preparation for colonoscopy. 
Aliment Pharmacol Ther 2007;25:373-84. 
9. 
Colonoscopy preparation, gastrointenstinal endoscopy ,2009,  69 (7) 
10. 
R M S Mitchell, K McCallion, K R Gardiner, R G P Watson, J S A Collins;  Successful 
colonoscopy; completion rates and reasons for Incompletion, The Ulster Medical Journal, 2002, 
71 ( 1), 34-37. 
11.  
Colin L Smith; Adenoma Detection on Repeat Colonoscopy after Previous Inadequate 
Preparation, Journal of Gastroenterology and Hepatology research, Vol 2, No 12 (2013) 
12.  
Hillyer GC, Basch CH, Lebwohl B, et al.; Shortened surveillance intervals following suboptimal 
bowel preparation for colonoscopy: results of a national survey. Int J Colorectal Dis. 2013;28:73–
81 
13.  
Harewood GC, Sharma VK, de Garmo P; Impact of colonoscopy preparation quality on detection 
of suspected colonic neoplasia. Gastrointestinal Endoscopy 2003; 58: 76-79 
14. 
Levin B, Lieberman DA, McFarland B, Andrews KS, Brooks D, Bond J, et al. Screening and 
surveillance for the early detection of colorectal cancer and adenomatous polyps, 2008: a joint 
guideline from the American Cancer Society, the US Multi-Society Task Force on Colorectal 
Cancer, and the American College of Radiology. Gastroenterology. 2008 May;134(5):1570-95. 
 
 
 
 

 
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19.0 
 Appendixes A: Study Design and Schedule of Assessment 
 
Visit 
Visit 1 
Colon Preparation 
Visit 2 
Contact 
Days 
>-5 days 
-1 to 0 days 
0 
48 hours 
Informed Consent* 
X 
 
 
 
Eligibility assessment (medical 
records, BMI, etc.) 
X 
 
 
 
Randomization 
X 
 
 
 
Colon Preparation Instructions 
X 
 
 
 
Medical History, Concomitant 
Medications, Demographic details 
X 
 
 
 
Diaries  
X 
(providing) 
X (by the patients) 
 
 
Patients’ satisfaction 
questionnaire 
X 
(providing) 
X  
X  
 
Bowel Preparation 
 
X (by the patients) 
 
 
Colonoscopy Procedure 
 
 
X 
 
Follow Up 
 
 
X  
X 
Adverse Events Reporting 
 
X 
 
 

 
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20.0 
Appendixes B: Bowel Preparation flow chart 
20.1 Appendixes B1: Bowel Preparation for morning procedures 
 
 
 
 
 
 
 
 
 

 
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20.2 Appendixes B2: Bowel Preparation for afternoon procedures 
 
 
 
 
 
 
 
 
 
 
 

 
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21.0 
Appendixes C: 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.  
 
 
 
 

 
 
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22.0 Appendix D – Patient Diary 
22.1 Diet Instructions for morning procedures 
No Seeds or Nuts 5 day before your procedure 
 
Drink at least two liters of CLEAR LIQUIDS per day beginning at 2 days prior to your procedure  
On the day before your Procedure You Can Eat the Following:  
Breakfast 
 20 oz of clear liquid 
 1-2 slices of white bread + cheese spread/ cottage cheese/ butter/ 
margarine/ 1 Tables poon of mayonnaise/ honey  
 1 plain yogurt/sour cream  
 Scrambled eggs ( 1-2 eggs) 
 Tea sweetened with white sugar or coffee added with a small amount of 
milk/cream  
Lunch 
 20 oz of clear liquid 
 1-2 slices of white bread with cheese spread, butter, margarine, honey.   
 4-6 oz of chicken soup containing skinless chicken, peeled potato, no 
vegetables.  
 Pasta or noodles with butter (no red sauce) or white rice 
Dinner 
 20 oz of clear liquid 
 1-2 slices of white bread + cheese spread/ cottage cheese/ butter/ 
margarine/ 1 Tables poon of mayonnaise/ honey  
 1 plain yogurt/sour cream 
  Pasta or noodles with butter (no red sauce) or white rice 
 Clear chicken soup  
 Tea sweetened with white sugar or coffee added with a small amount of 
milk/cream 
 
 On the procedure day: 
Clear-liquid diet up to 3 hours prior to the procedure  
Fasting (no food / liquids) start 3 hours prior to procedure time 
 

 
 
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22.2 Diet Instructions for afternoon procedures 
No Seeds or Nuts 5 day before your procedure 
 
Drink at least two liters of CLEAR LIQUIDS per day beginning at 2 days prior to your procedure  
On the day before your Procedure You Can Eat the Following:  
Breakfast  20 oz of clear liquid 
 1-2 slices of white bread + cheese spread/ cottage cheese/ butter/ margarine/ 1 
Tables poon of mayonnaise/ honey  
 1 plain yogurt/sour cream  
 Scrambled eggs ( 1-2 eggs) 
 Tea sweetened with white sugar or coffee added with a small amount of milk 
Lunch 
 20 oz of clear liquid 
 1-2 slices of white bread with cheese spread, butter, margarine, honey.   
 4-6 oz of chicken soup containing skinless chicken and peeled potato.  
 Pasta or noodles with butter (no red sauce) or white rice 
Dinner 
 20 oz of clear liquid 
 1-2 slices of white bread + cheese spread/ cottage cheese/ butter/ margarine/ 1 
Tables poon of mayonnaise/ honey  
 1 plain yogurt/sour cream 
  Pasta or noodles with butter (no red sauce) or white rice 
 Clear chicken soup  
 Tea sweetened with white sugar or coffee added with a small amount of milk 
 
   On the day of your Procedure You Can Eat a light breakfast as the Following: 
Breakfast 
 20 oz of clear liquid 
 1-2 slices of white bread + cheese spread/ cottage cheese/ butter/ 
margarine/ 1 Tables poon of mayonnaise/ honey  
 1 plain yogurt/sour cream 
 Tea sweetened with white sugar or coffee without milk/cream  
 
Clear-liquid diet up to 3 hours prior to the procedure  
Fasting (no food / liquids) start 3 hours prior to procedure time 

 
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22.3 Meal and Liquids Log 
Please indicate the type and value of the food and liquids you consumed during the preparation days: 
 
Day -1 (Day prior to 
procedure) 
Day of Procedure 
Nothing Per Oral 3 Hours 
Prior to Colonoscopy 
Breakfast 
Food 
 
Volume and 
Type of Clear 
Liquids 
Lunch 
Food 
After the procedure please 
return to your normal daily 
diet 
 
Volume and 
Type of Clear 
Liquids 
Dinner 
Food 
Volume and 
Type of Clear 
Liquids 
 
 

 
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22.5 Bowel Movements Log 
Day -1 (Day prior to procedure) 
Day of Procedure 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
Time of BM:  
 
Please Circle: Formed  or  Liquid 
 
 
 
 
 

 
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23.0 
Appendix E – Case Report Form (filled-in by the patient) 
 
Pure-Vu™ 
Patient Satisfaction Questionnaire 
 
Procedure Date / Patient ID Number:___________________/___________________ 
 
Physician Name:  ______________________________________________________ 
 
The patient will answer the following questions prior the colonoscopy procedure 
 
Question #1 
Yes 
No 
Was this your first colonoscopy? 
  
  
 
 Question #2 
Very 
Easy 
Easy 
Tolerable 
Difficult 
Very        
Difficult 
How tolerable did you find the low fiber 
diet in this bowel preparation process? 
  
  
  
  
  
How tolerable did you find the bowel 
cleansing purgative in this bowel 
preparation process? 
  
  
  
  
  
How disruptive was the bowel 
preparation process to your normal 
activities? 
 
 
 
 
 
 
 Question #3 
If you could change two things in the bowel preparation process, what would they be? 
1 
2 
 
 
 

 
CONFIDENTIAL 
Document title: 
Document No.  
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61 
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Colonoscopy Procedure  with Pure-Vu System     
CL00042 
1.0 
 
 
 
  
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Page 53 of 61 
 
 
 
The patient will answer the following questions after the colonoscopy procedure during the 
follow up phone call (will be filled by the site study coordinator) 
 
 Question #4 
Yes 
No 
Based upon your experience with Pure-Vu, would you recommend Pure-
Vu to your friends and family members who need a colonoscopy? 
  
  
 
Please explain why: 
____________________________________________________________________________________________________________ 
 
_____________________________________________________________________________________________________________ 
 
 Question #5 
Yes 
No 
Would you request Pure-Vu for your next colonoscopy? 
  
  
 
 
 Question #6 
Yes 
No 
Would you request Pure Vu again for your next colonoscopy if it cost $300?   
  
 
 
 
If this was not your first colonoscopy, please answer questions 7 – 11. 
Please answer question 7-10  prior the colonoscopy procedure. Please add any additional 
comments at the end of the questionnaire  
 
 Question #7 
Yes 
No 
Was this preparation different from your previous preparation? 
  
  
 
If the preparation was different, please explain how and / or why: 
 
_____________________________________________________________________________________________________________ 
 
_____________________________________________________________________________________________________________ 
 
 

 
CONFIDENTIAL 
Document title: 
Document No.  
Version 
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61 
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Colonoscopy Procedure  with Pure-Vu System     
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Page 54 of 61 
 
 
 
 Question #8 
This Pure-Vu prep 
was more tolerable 
than before 
This Pure-Vu 
prep was about 
the same as 
before 
This Pure-Vu 
prep was less 
tolerable than 
before 
How would you compare the 
tolerability of the 
preparation with Pure-Vu to 
your previous colonoscopy? 
  
  
  
 
If the tolerability of this preparation was different, please explain how and / or why: 
 
_____________________________________________________________________ 
 
_____________________________________________________________________ 
 
 
 Question #9 
Pure-Vu diet was 
better than 
before 
Pure-Vu diet was 
about the same as 
before 
Pure-Vu diet 
was worse than 
before 
How would you compare the 
dietary restrictions with Pure-
Vu to your previous 
colonoscopy? 
  
  
  
 
If your dietary experience was different, please explain how and / or why: 
 
_________________________________________________________________________________ 
 
____________________________________________________________________________ 
 
 
 
 
 
 
 

 
CONFIDENTIAL 
Document title: 
Document No.  
Version 
Page 55 of 
61 
Optimizing the Preparation Regime Prior to 
Colonoscopy Procedure  with Pure-Vu System     
CL00042 
1.0 
 
 
 
  
CL00042/ Protocol, Version 1.0 December 13, 17 
 
Page 55 of 61 
 
 
 
 Question #10 
Pure-Vu 
experience was 
less disruptive 
than before 
Pure-Vu 
experience 
was about the 
same as 
before 
Pure-Vu 
experience was 
more disruptive 
than before 
How would you compare the 
disruption to your daily 
activities with Pure-Vu to your 
previous colonoscopy 
experience? 
  
  
  
 
If the disruption to your daily activities was different, please explain how and / or why: 
 
______________________________________________________________________________ 
 
______________________________________________________________________________ 
 
 
The patient will answer the following question after the colonoscopy procedure during the 
follow up phone call (will be filled by the site study coordinator) 
 
 Question #11 
Pure-Vu 
experience was 
better than 
before 
Pure-Vu 
experience was 
about the same as 
before 
Pure-Vu 
experience was 
worse than 
before 
How would you compare 
your overall Pure-Vu 
experience to your previous 
colonoscopy experience? 
  
  
  
 
If your experience was different, please explain how and / or why: 
 
_______________________________________________________________________________ 
 
_______________________________________________________________________________ 
 
 
 

 
CONFIDENTIAL 
Document title: 
Document No.  
Version 
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61 
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Colonoscopy Procedure  with Pure-Vu System     
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24.0 
Appendix F – Case Report Form (filled-in by the physician) 
 
 
      
                                                                                                            
          Site No.            Subject No.          Subject Initials 
 
 
Study arm:   
 
     Magnesium Citrate 10 oz                 Magnesium Citrate 15 oz                
 
 
 
Physician Name:  _____________________________________________________________ 
 
 
Date subject signed the informed consent form:       _____ /  ____  / _____ 
 
 
 
 
 
 
        DD       MM         YY 
 
 Date investigator/designee signed the informed consent form:           _____ /  ____  / _____ 
 
 
 
 
 
 
 
 
          DD          MM           YY 
 
 
Did the subject satisfy all enrollment criteria?                   □Yes □ No    (if No, please specify 
which criterion was not met)                                     
 
__________________________________________________________________________________ 
 
 
Procedure date:       _____ /  ____  / _____ 
 
 
         DD 
        MM         YY 
Patient Gender / Age:  __________ / ______ 
 
Patient Height (cm) / Weight (kg):  ________ / ___________ 
 
Please check all indications that apply for the patients’ 
colonoscopy 
Please Check 
Screening 
 
Bleeding 
  
Polyp surveillance 
  

 
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IBD surveillance 
 
Family history (1st degree relative) 
  
Anemia 
  
Other:  Please specify   
  
 
 
 Prescribed Prep 
Completed  
Yes / No 
Magnesium Citrate 10oz:  
  
Magnesium Citrate 15oz: 
  
 
 
  
HH : MM 
Colonoscopy start time 
 
Time cecum reached 
  
Time colonoscopy ended 
 
 
 
 Please rate the bowel prep 
BBPS Rating Prior to 
Use of Pure-Vu (0 - 3) 
BBPS Rating After Use of 
Pure-Vu (0 - 3) 
Descending colon 
  
  
Transverse colon 
  
  
Ascending colon 
  
  
 
Comments:  _____________________________________________________________________________________________ 
 
____________________________________________________________________________________________________________ 
 

 
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Sigmoid / 
Descending 
Transverse 
Ascending 
If the cecum was not reached during the 
colonoscopy procedure, please indicate the 
furthest anatomical landmark reached 
  
  
  
 
If cecum not reached, please indicate the reason 
Please Check 
Poor bowel cleanliness 
  
Patient intolerance / discomfort 
  
Clinical and anatomical (such as stricture, redundant colon, etc.) 
  
Other:  Please specify 
 
________________________________________________________________________________ 
 
________________________________________________________________________________ 
 
 
  
 
 Usability 
Excellent  Good 
Acceptable 
Difficult 
Unacceptable 
Ease of colonoscope 
advancement with Pure-Vu   
  
  
  
  
Ease of navigating 
colonoscope with Pure-Vu 
  
  
  
  
  
Torque ability of 
colonoscope with Pure-Vu 
 
 
 
 
 
Ease of sigmoid passing 
 
 
 
 
 
Ease of retroflex 
 
 
 
 
 
 
 
 

 
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Were there any polyps detected during the procedure?       □Yes □ No 
 
Polyp 
Size (mm) 
Polyp 
location 
 
Histology results 
Type of 
intervention 
Time of 
Intervention 
(mins) 
 
 
 
  
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
  
 
 
 
Comments: 
___________________________________________________________________________ 
 
___________________________________________________________________________ 
 
Follow Up information 
DD / MM / YY 
48 hours follow up call date  
 ____ / ____ / ______ 
Follow up outcome: 
  
 
 
 

 
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Document No.  
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Colonoscopy Procedure  with Pure-Vu System     
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Report Serious Adverse Event (SAE) within 48 hours of learning the event 
 
Adverse Event (AE) Form 
Please Check 
Have any AEs occurred during the study? 
 Yes / No 
If yes,  
Start Date  
 ___ / ___ / ___ 
 DD    MM   YY 
End Date  
 ___ / ___ / ___ 
 DD    MM   YY 
Description: 
 
Tissue trauma 
 
Excessive bleeding 
 
Laceration 
 
Other: _________________________ 
 
Death 
Severity 
 
Mild 
 
Moderate 
 
Severe 
Anticipated 
Yes / No 
Relation to the study 
 
Unrelated 
 
Unlikely 
 
Possibly 
 
Related 
Was the AE serious AE? 
Yes / No 
If yes, specify the reason 
 
Death 
 
Life threatening 
 
Hospitalization 
 
Persistence /  significant disability / 
incapacity 
 
Congenital anomaly / birth defect 
 
Important medical event (subject’s 
health is at risk and intervention is 
required to prevent one of the above 
events) , specify   

 
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Document title: 
Document No.  
Version 
Page 61 of 
61 
Optimizing the Preparation Regime Prior to 
Colonoscopy Procedure  with Pure-Vu System     
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Date of Event report to the IRB: 
 
___ / ___ / ___ 
 DD    MM   YY 
 
Treatment? 
Yes / No 
If yes, specify type and reason 
Pharmacological treatment 
________________________________ 
 
Other medical intervention 
_________________________________ 
Outcomes 
 
Resolve 
 
Improved 
 
Unchanged 
 
Worsen 
 
Insufficient follow up 
 
Comments: 
_________________________________ 
Investigator signature 
 
Date 
 
 
___ / ___ / ___ 
 DD    MM   YY