Post Market Evaluation of Aer-O-Scope Visualization
Phase: NA
Conditions: Cancer
Sponsor: GI View Ltd.



Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
Page 2 of 30 
1 
GENERAL 
1.1 
Introduction 
The Aer-O-Scope® Colonoscope System is a joystick operated self-propelled, disposable 
colonoscope designed to improve visualization behind folds, eliminate the possibility of disease 
transmission and be safe and easy to use. The Aer-O-Scope has a unique omni-directional 360˚ 
view optics, that provide the operator with a 360° field of view.   
There is no perfect gold standard for colorectal cancer detection. Conventional colonoscopy, which 
is an imperfect gold standard, frequently misses polyps and even large tumors, especially those 
that are located behind colonic folds. The Aer-O-Scope Colonoscope System, with its omni-
directional 360° view capability, was designed to view behind folds and lower the rates of missed 
polyps. Preclinical animal trials demonstrated that the Aer-O-Scope Colonoscope System was 
superior to conventional colonoscopy in visualizing polypsi. This current clinical investigation is 
intended to compare the visualization of the Aer-O-Scope Colonoscope System to that of 
conventional colonoscopes commonly used in GI practices today. 
 
1.2 
Identification of the Clinical Investigation Plan 
 
 
1.3 
Sponsor 
Sponsor 
GI View Ltd. 
5 Shoham St. 
5251001 Ramat Gan 
Israel 
Representative 
Israel: 
Sharon Goldfarb; +972-54-6454034; sharon@giview.com 
USA: 
TBD – To be added prior to USA IRB submission 
 
1.4 
Principal Investigator, Coordinating Investigator and Investigation Site(s) 
See Appendix 1: Participating Investigators 
 
 
 
Clinical Investigation 
Post Market Evaluation of Aer-O-Scope™  Visualization  
Reference Number 
934CLD 
Version of the CIP 
Rev. 02 
Amendments 
n/a 
Version/Issue Number and 
Reference Number 
n/a 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
Page 3 of 30 
1.5 
Overall Synopsis of the Clinical Investigation  
Inclusion/Exclusion 
Criteria 
Inclusion Criteria: 
 
1. Subject is indicated for screening, diagnostic (minor complaints such as 
rectal bleeding or minor abdominal pain) or surveillance colonoscopy 
2. Subject willing to undergo tandem colonoscopies with Aer-O-Scope 
Colonoscope and a conventional colonoscope (including a single colon 
preparation bowel cleansing)  
3. Subject between the ages of 45 and 75 (patients between the ages of 45 
and 50 must have a family history of a first degree relative with onset of 
colon cancer before the age of 60). 
4. Subject is able to understand and willing to sign informed consent form 
Exclusion Criteria: 
 
1. Personal history of colorectal neoplasia including familial adenomatous 
polyposis or hereditary nonpolyposis, colon cancer (HNPCC). 
2. Diagnosis of active (flaring) inflammatory bowel disease (active ulcerative 
colitis or Crohn’s colitis), bowel obstruction, or acute diverticulitis, or known 
severe diverticulosis, fecal incontinence or any known large-bowel disease 
that would require a predetermined therapeutic colonoscopy (non-
screening, non-diagnostic or non-surveillance cases) 
3. Severe gastrointestinal tract-related symptoms, or complaints, suggesting 
performance of a pre-determined therapeutic colonoscopy (non-screening, 
non-diagnostic or non-surveillance cases) 
4. History of colonic resection 
5. Clinically significant cardiovascular or pulmonary disease.   
6. Cancer or other life threatening disease or significant chronic condition that 
puts the subject at risk. 
7. Blood-clotting disorders and/or current anticoagulant therapy (Subjects 
taking up to 100mg aspirin for prophylactic treatment are acceptable for 
this study) 
8. Pregnancy 
9. Previous radiation therapy to the abdomen  
10. Morbid Obesity (BMI > 40 kg/m2) 
11. Drug abuse or alcoholism 
12. Subject is bed-ridden and/or unable to adequately communicate  
13. Subject is under custodial care 
14. Subject  has  a  history of  psychiatric  disorders  which  would prevent 
compliance with study instructions 
15. Participation in a clinical study within the previous 30 days 
 
 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
Page 4 of 30 
Number of Subjects 
Three hundred and 10 (310):  
Up to ten (10) training cases per investigator  per site) plus eighty (80) study 
subjects per site (between one hundred (100) and one hundred and ten 
(110)subjects per site (dependent on the number of investigators including  
training cases) 
Each site will have three (3) study cohorts: 
 Training cohort (up to the first 10 cases per investigator) Aer-O-
Scope colonoscopy followed by conventional colonoscopy (not part of 
the statistical evaluation for visualization) 
 Aer-O-Scope colonoscopy followed by conventional colonoscopy 
 Conventional colonoscopy followed by Aer-O-Scope colonoscopy 
Study Duration 
One (1) Year  
Study Objectives 
1. Primary Objectives:  
1.1. To measure the adenoma miss rate (AMR) (based on histology) for 
the Aer-O-Scope colonoscopy as compared to the AMR for 
conventional colonoscopy in a tandem back-to-back study.  
The AMR is defined as the percentage of adenomas missed per 
cohort (either by the Aer-O-Scope colonoscope or a conventional 
colonoscope) and is measured by the number of missed adenomas 
(detected in the second pass colonoscopy) divided by the total 
number of adenomas detected per cohort.  
See Number of Subjects above for cohort group definitions 
 
1.2. To demonstrate the Aer-O-Scope Colonoscope System is safe for the 
performance of screening, diagnostic (minor cases such as rectal 
bleeding and/or abdominal pain) and polyp surveillance colonoscopy. 
 
2. Secondary Objectives: 
2.1. To measure the polyp miss rate (PMR) for the Aer-O-Scope 
colonoscopy as compared to the PMR for conventional colonoscopy 
in a tandem back-to-back study.  
The PMR is defined as the percentage of polyps missed per cohort 
(either by the Aer-O-Scope colonoscope or a conventional 
colonoscope) and is measured by the number of missed polyps 
(detected in second pass colonoscopy) divided by the total number of 
polyps detected per cohort.  
(See Number of Subjects above for cohort group definitions). 
2.2. To measure the advanced adenoma (≥10mm with villous histology or 
with high grade dysplasia based on histology) miss rate (AAMR) for 
the Aer-O-Scope colonoscopy as compared to the AAMR for 
conventional colonoscopy in a tandem back-to-back study.  
The AAMR is defined as the percentage of advanced adenomas 
missed per cohort (either by the Aer-O-Scope colonoscope or a 
conventional colonoscope) and is measured by the number of missed 
advanced adenomas (detected in second pass colonoscopy) divided 
by the total number of polyps detected per cohort.  

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
Page 5 of 30 
It should be noted that the expected number of advanced adenomas 
will be significantly lower than the number of polyps and the number 
of adenomas.  The evaluation of this objective will most likely not 
reach statistical significance due to the small expected sample size of 
advanced adenomas. 
2.3. To define and document the learning curve for the operation of the 
Aer-O-Scope Colonoscope System and use of therapeutic access 
using the Aer-O-Scope Colonoscope System – Using a 5 point Likert 
Scale (for perceived physician proficiency). The first ten (10) cases 
will be training for system operation.  The first twenty (20) therapeutic 
interventions per physician will be training for therapeutic access. 
2.4. Colonoscopy timing for both Aer-O-Scope and conventional 
colonoscopy will be documented for the following properties: 
2.4.1. 
Cecal intubation time (not including therapeutic intervention 
times) 
2.4.2. 
Withdrawal time (not including therapeutic intervention times) 
2.4.3. 
Total procedure time (not including therapeutic intervention 
times) 
3. Tertiary Objectives: 
3.1. Timing of therapeutic interventions (see Appendix 3: Therapeutic 
Accessories Used in This Study) performed with the Aer-O-Scope 
Colonoscope System will be documented for the purpose of data 
collection only 
Study Endpoints 
1. Primary 
1.1. Adenoma miss rates (AMR) for each study cohort  
1.2. No serious adverse events or serious adverse device effects using 
the Aer-O-Scope Colonoscope System. 
2. Secondary 
2.1. Polyp miss rates (PMR) for each study cohort  
2.2. Advanced adenoma miss rates (AAMR) for each study cohort  
2.3. Perceived proficiency in Aer-O-Scope operation, mean Likert score 
between1-3.   
2.4. Cecal intubation time (not including therapeutic intervention times) 
2.5. Withdrawal times (not including therapeutic intervention times) 
2.6. Total procedure time (not including therapeutic intervention times) 
3. Tertiary 
3.1. Therapeutic intervention metrics (time, tool, success rate)  
 
2 
IDENTIFICATION AND DESCRIPTION OF THE INVESTIGATIONAL DEVICE 
Manufacturer 
GI View Ltd.  
Model/Type 
Aer-O-Scope Colonoscope System   
(MASA 0101-0202) 
Traceability 
Work station will be identified by Catalog number and serial number. Aer-O-
Scope Disposable Scanner will be identified by serial number and lot number. 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
Page 6 of 30 
Released software will be identified by SW number and revision.  All systems 
will be traced using a specific device traceability form in accordance with GI 
View SOP 690CLP Device Inventory and Accountability or equivalent ISO 
14155:2011 compliant SOP from the company’s CRO.  
Intended Purpose 
The Aer-O-Scope Colonoscope System is intended to provide panoramic 
(360°) visualization (via a video monitor) and diagnostic/therapeutic access to 
the adult lower gastrointestinal tract, (including but not limited to, the anus, 
rectum, sigmoid colon, transverse colon, cecum and ileocecal valve) for 
endoscopy. 
The Aer-O-Scope Scanner (colonoscope component of the Aer-O-Scope 
System) is a single use, disposable device. The  Aer-O-Scope Scanner 
cannot be reprocessed.  
Populations 
The Aer-O-Scope Colonoscope System is intended for adult populations 
indicated for screening, diagnostic (minor complaints such as rectal bleeding 
or minor abdominal pain) or polyp surveillance colonoscopy. 
Investigational Device 
Description 
The 
Aer-O-Scope 
Colonoscope 
System 
provides 
panoramic 
(360°) 
visualization (via an external video monitor) and diagnostic/therapeutic access 
to the adult lower gastrointestinal tract for endoscopy (including but not limited 
to, the anus, rectum, sigmoid colon, transverse colon, cecum and ileocecal 
valve). The system has two main components: 
• 
The Aer-O-Scope Workstation – Facilitates the operation of the Aer-O-
Scope Disposable Scanner. This includes supply and control over CO2, 
water, suction, air pressure, and the power supply for the camera and 
illumination. The Aer-O-Scope Workstation receives and processes data 
sent to and from the Aer-O-Scope Disposable Scanner including 
pneumatic controls, video signals from the camera and the pressure 
measurements utilized by the Aer-O-Scope propulsion system to manage 
navigation within the colon. The Workstation features an ergonomic 
joystick for the control of the Aer-O-Scope Disposable Scanner optical 
imaging head steering to streamline navigation. 
• 
The Aer-O-Scope Disposable Scanner – Is the colonoscope component 
of the System. The Aer-O-Scope Disposable Scanner is a single-use, 
self-propelled device that incorporates a CMOS chip that facilitates the 
introduction of the highly sophisticated visualization system, featuring 
360° panoramic omni-view capabilities. The scanner moves through the 
entire colon and into the cecum.  The Scanner captures high-resolution 
video images of the colon mucosa, transmitted in real-time, to the 
workstation and then video monitor and is digitally recorded for future 
reference. The propulsion mechanism uses a series of soft pliable 
polyurethan balloons and CO2 gas to propel the optical imaging head into 
and then out of the colon. Two working channels for the provision of 
therapeutic access are incorporated in the scanner. The Scanner is 
disposable and cannot be reprocessed. 
Training 
For the purpose of this study, the operators will be expert GI endoscopists. 
Each operator will undergo 2-3 day(s) of training including didactic 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
Page 7 of 30 
presentations regarding the operation of the Aer-O-Scope. Hands on 
experience operating the system in a model will also be provided prior to 
initiating the study. Training procedures for general operation of the system 
will be included in up to the first ten (10) procedures in the study – the exact 
number to be determined by the physician’s perceived proficiency based on a 
Likert Scale questionnaire. Up to the first twenty (20) therapeutic interventions 
will be considered therapeutic training procedures – the exact number to be 
determined by the physician’s perceived proficiency based on a Likert Scale 
questionnaire.    Up to the first 10 training procedures will not be analyzed in 
the final statistical analysis for polyp visualization. 
Medical Procedure 
The Aer-O-Scope Disposable Scanner like any conventional colonoscope is 
inserted into the rectum and then maneuvered to the cecum.  The Aer-O-
Scope has an incorporated propulsion system to advance the optical imaging 
head through the colon.  The propulsion system utilizes soft pliable balloons 
and CO2 gas to gently propel the optical imaging head inwards on intubation 
and outwards upon retraction.  The operator gently eases the multi-luminal 
cable inward towards the cecum during the insertion phase and gently pulls 
the cable during retraction scan phase both while steering the optical imaging 
head with the ergonomic joystick. 
If pathology of any type is detected during the procedure, a standard 
therapeutic accessory (at least 230cm in length and ≤1.8mm in diameter) is 
inserted through one of the Aer-O-Scope two (2) working channels (2.1mm 
diameter each) and the polyp is removed or biopsied. In the event that the 
pathology cannot be removed due to size, shape and/or location, the area 
adjacent to the pathology is tattooed to mark for later therapeutic intervention. 
In this study, subjects will undergo tandem colonoscopy with the Aer-O-Scope 
Colonoscope System and a conventional colonoscope (see Appendix 2: 
Conventional Colonoscopes Used in this Investigation). Subjects will be 
randomized in blocks to begin either with the Aer-O-Scope Colonoscope 
System or with the conventional colonoscope.  The same endoscopist will 
perform both procedures.  Because the physicians will see which device they 
are using to perform the colonoscopies, blinding will not be possible. 
Each subject will undergo colonoscopy in tandem with each device.  All 
pathologies will be removed (or tattooed) during the procedures. 
Data will be documented on Case Report Forms (973CLD).  Data related to 
adenomas will be retrieved from histology reports. 
 
 
 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
Page 8 of 30 
3 
JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION 
Pre Clinical Testing/ 
Assessment 
This post marketing study is intended to demonstrate the ability to better 
visualize colonic abnormalities using the Aer-O-Scope Colonoscope System.  
During the course of the last decade, several major visualizations studies have 
been performed and it has become common practice to use the “second-pass” 
method for determining visualization methodsii,iii,iv.  This study is intended to 
demonstrate a significantly lower adenoma miss rate using the Aer-O-Scope 
Colonoscope System as compared to a conventional colonoscope. 
GI View performed a comparative visualization study in swine during the course 
of 2013 and 2014 and demonstrated a superior ability to visualize pathologies 
as compared to an Olympus CF140L colonoscopev. 
GI View performed an ex vivo study using harvested swine colons with 
implanted pseudo-polyps to demonstrate the ability of the Aer-O-Scope 
Colonoscope 
System 
to 
provide 
therapeutic 
access 
for 
therapeutic 
interventions. 
Following an extensive review of the published biomedical literature, GI View 
designed this study to be the same as similar studies in the published literature.   
The population in this study is the same population indicated for screening, 
diagnostic and surveillance colonoscopy as seen in the published professional 
literature.  A list of articles can be found in Appendix 4: Bibliography. 
4 
INVESTIGATIONAL DEVICE AND CLINICAL INVESTIGATION RISKS & BENEFITS 
Risks 
The risks associated with the Aer-O-Scope Colonoscope are similar to those 
risks associated with conventional optical colonoscopy.  As with all 
procedures related to colon screening, there are some associated risks.  
Risks associated with both colonoscopy and the Aer-O-Scope Colonoscope 
may include but are not limited to the following: 
• 
Lower digestive tract bleeding,  
• 
Colon perforation (that may result in inflammation of the peritoneum 
(peritonitis) or need for emergency medical treatment),  
• 
Excessive insufflation of the colon,  
• 
Erosion of the colon mucosa,  
• 
Sepsis  
• 
Venous thrombosis,  
• 
Vasovagal events,  
• 
Pain,  
• 
Ano-rectal Fissures, 
• 
Bloating and  
• 
Discomfort.  
Anticipated adverse device effects include bloating, flatulence mild in nature, 
ano-rectal fissures and minor discomfort. These symptoms are all transient 
and do not pose a potential risk to the subjects’ health. 
The Aer-O-Scope Colonoscope system has been designed to minimize 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
Page 9 of 30 
these adverse effects. 
Benefits 
Colonoscopy is the gold standard for colon inspection and is a safe and 
effective procedure.  Previous studies of colonoscopy have proven beneficial 
in the prevention of colon cancer. The Aer-O-Scope Colonoscope may allow 
a simpler and faster examination, potentially resulting in increased capacity 
and thus shorter waiting periods for the colon examination.  
The Aer-O-Scope Colonoscope’s unique video system with both forward and 
omni-directional (360° panoramic) cameras allows greater visualization of 
the colon both in front and behind the colonic folds as compared to 
conventional forward-viewing colonoscopy.  This was demonstrated in the 
comparative animal study.   A higher detection rate has been shown to lead 
to lower rates of interval cancers. 
In addition, the Aer-O-Scope Colonoscope Disposable Scanner is a single 
use device.  As such, each subject receives a new, unused, clean device, 
eliminating the risk of infectious disease transmission from improper or 
inadequate high level disinfection.  This also reduces the amount of toxic 
chemicals needed for high-level disinfection.   
The Aer-O-Scope Colonoscope design is intended to potentially lower the 
risk of colonic perforation by using a soft and very flexible multi-lumen cable 
– rather than the more rigid tube used with standard colonoscopes.  This 
design has the potential for substantially reducing the risk of colonic 
perforation, which can be life threatening.   
 
 
 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
Page 10 of 30 
5 
HYPOTHESES OF THE CLINICAL INVESTIGATION 
Hypotheses 
1. Primary Hypotheses:  
1.1. Colonoscopy with the Aer-O-Scope Colonoscope System will 
have lower AMR than the conventional forward-viewing 
colonoscopes. The mean adenoma miss rate for conventional 
colonoscopy as found in the published literature is between 15-
40%.  
The number missed adenomas (NMA) (based on histology) for 
each of the two cohort groups in back-to-back tandem 
colonoscopy will be measured.  
The NMA is defined as the number of adenomas (based on 
histology) detected during the second pass colonoscopy that 
were not detected and removed (or tattooed) during the first pass 
colonoscopy. 
The AMR will be measured by the NMA divided by the total 
number 
of 
adenomas 
detected 
(for 
each 
cohort). 
 
1.2. Colonoscopy with the Aer-O-Scope Colonoscope System is safe 
for 
screening, 
diagnostic 
and 
surveillance 
colonoscopy.  
 
2. Secondary Hypotheses: 
2.1. Colonoscopy with the Aer-O-Scope Colonoscope System will 
have a lower PMR than the conventional forward-viewing 
colonoscopes.  
The number missed polyps (NMP) for each of the two cohort 
groups in back-to-back tandem colonoscopy will be measured.  
The NMP is defined as the number of polyps detected during the 
second pass colonoscopy that were not detected and removed 
(or tattooed) during the first pass colonoscopy. 
The PMR will be measured by the NMP divided by the total 
number 
of 
adenomas 
detected 
(for 
each 
cohort). 
 
2.2. Colonoscopy with the Aer-O-Scope Colonoscope System will 
have lower AAMR than the conventional forward-viewing 
colonoscopes.  
The number missed advanced adenomas (NMAA) (based on 
histology) for each of the two cohort groups in back-to-back 
tandem colonoscopy will be measured.  
The NMAA is defined as the number of advanced adenomas 
(based on histology) detected during the second pass 
colonoscopy that were not detected and removed (or tattooed) 
during 
the 
first 
pass 
colonoscopy. 
The AAMR will be measured by the NMAA divided by the total 
number of adenomas detected (for each cohort).  Because 
approximately only 6% of all adenomas are considered advanced 
adenomas, the evaluation of this objective will most likely not 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
Page 11 of 30 
reach statistical significance due to the small expected sample 
size 
of 
advanced 
adenomas. 
 
2.3. Physicians will be proficient in operation of and visualization with 
the Aer-O-Scope Colonoscope System within the first ten (10) 
cases.  Perceived proficiency will be measured using the five (5) 
point Likert Scale shown below. Physicians will be asked to 
grade 
their 
performance 
proficiency 
of 
intubation, 
maneuverability, scanning (withdrawal) and visualization using 
the Aer-O-Scope Colonoscope System throughout the study.  
For the purpose of this study, the Likert Scale will be used only 
for Aer-O-Scope colonoscopies. 
Physicians will be proficient in the achievement of therapeutic 
access for the purpose of therapeutic interventions within the 
first 20 therapeutic interventions (per physician).  Perceived 
proficiency will be measured using the five (5) point Likert Scale 
shown below. Physicians will be asked to grade their 
performance proficiency of tool insertion, maneuverability and 
ability to perform therapeutic intervention via the Aer-O-Scope 
colonoscope.  For the purpose of this study, the Likert Scale will 
be used only for the Aer-O-Scope colonoscopies. An overall 
score between 1 and 3 will be considered proficient.  
LIKERT 
SCALE 
USABILITY 
 
1 
Easy to perform  
2 
Slightly complicated to perform  
3 
Neutral (Neither easy nor difficult) 
4 
Complicated to perform  
5 
Very Complicated to perform  
 
2.4. Colonoscopy timing with the Aer-O-Scope Colonoscope System 
and 
conventional 
forward-viewing 
colonoscopes 
will 
be 
documented for data collection only for the following properties: 
 
2.4.1. Time to cecal intubation – procedures will be timed using 
a stopwatch.  The time spent on therapeutic interventions 
will be deducted from the intubation time. The Aer-O-
Scope and conventional colonoscopes will be equivalent. 
2.4.2. Withdrawal time - procedures will be timed using a 
stopwatch.  The time spent on therapeutic interventions 
will be deducted from the withdrawal time. The Aer-O-
Scope and conventional colonoscopes will be equivalent. 
2.4.3. Total procedure time – The total procedure time will be 
recorded from initial intubation through final retraction. 
The time spent on therapeutic interventions will be 
deducted from the overall time. The Aer-O-Scope and 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
Page 12 of 30 
conventional colonoscopes will be equivalent. 
Claims and 
Performance 
The Aer-O-Scope Colonoscope System will have a lower overall number 
of missed adenomas as compared with conventional forward-viewing 
colonoscopy. An interim analysis will be performed upon completion of 
each study site. 
Risks and Adverse 
Effects 
All serious adverse events and unexpected adverse events as well as 
adverse device effects will be evaluated in the course of this study. 
 
6 
DESIGN OF THE CLINICAL INVESTIGATION 
6.1 
General  
This will be a prospective multi-center, multi-national comparative non-blinded clinical investigation. 
Each subject will undergo back-to-back tandem colonoscopies with the Aer-O-Scope Colonoscope 
System and a conventional colonoscope (for a list of scopes to be used, see Appendix 2) since this 
is a tandem colonoscopy study, each subject will serve as their own control.  The 1st procedure will 
be randomized, half to Aer-O-Scope Colonoscope System and half to conventional colonoscope. 
The same investigator will perform both procedures on each subject.  All pathologies found will be 
either removed or tattooed. Unmarked pathologies found on second pass will represent those 
missed during the 1st pass, thus making the subject and the control one and the same. Tattooed 
pathologies that can be removed endoscopically will be removed in an additional colonoscopy.  This 
may occur if a large polyp cannot be removed for any reason with the Aer-O-Scope, but can be 
removed with conventional colonoscopy. 
Subjects will be randomized in blocks of twenty (20) for either Aer-O-Scope or conventional 
colonoscopy as the first procedure.   Physicians will be notified of the procedural order immediately 
prior to first colonoscopy.  Up to the first ten (10) cases for each physician (system operation 
training cases) will all begin with the Aer-O-Scope colonoscopy as the first procedure.  
The primary endpoint of AMR was chosen as this measure appears to be related to the 
performance of colonoscopy and reduction in colorectal cancer incidence. During the course of the 
last decade, several major visualizations studies have been performed and it has become common 
practice to use the “second-pass” method for measuring colonoscopy visualization methods,iii,iv.  In 
the “second-pass” method, during the course of the first colonoscopy, all visualized lesions are 
removed (or tattooed in the event that they cannot be removed for any reason.).  Any unmarked 
abnormalities discovered during the second pass colonoscopy are considered to be missed 
pathologies for the first pass colonoscopy.    
All endpoints related to timing will be measured using a stopwatch and overall time stamp from the 
Aer-O-Scope or conventional colonoscope.  Time to perform therapeutic interventions with Aer-O-
Scope as well as a description of said interventions will also be recorded. The same instruments will 
be used to measure all procedures and will be calibrated as dictated by the manufacturer. 
All equipment used during the course of this clinical investigation will undergo calibration and 
testing as per the manufacturing instructions.  The Aer-O-Scope Colonoscope System has an 
automated calibration system and diagnostic test that run daily.  Conventional colonoscopes will be 
maintained as per hospital/manufacturer protocol. 
Recruited subjects who are withdrawn as a result of poor bowel prep or any other medical 
determination leading to the inability to undergo colonoscopy and/or tandem colonoscopy will be 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
Page 13 of 30 
replaced. A poor prep is defined as having a score of score of 0 or 1 in the Boston Bowel 
Preparation Scale (BBPS).  The BBPS scores are as follows: 
 
0 =  Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.  
1 =  Portion of mucosa of the colon segment seen, but other areas of the colon segment not well 
seen due to staining, residual stool and/or opaque liquid. 
2 =  Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of 
colon segment seen well. 
3 =  Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or 
opaque liquid.  
   
Any subject withdrawn as a result of physician discretion due to concomitant medical issues will be 
withdrawn prior to the actual colonoscopic procedures. Patients with a large polyp (>20mm) 
removed during the first pass with a conventional colonoscope will be withdrawn.  Patients who 
receive treatment during the first pass with clips (no other option available) will be withdrawn. 
Coagulation therapy should be performed either with Argon Plasma Coagulation (APC) or another 
cautery tool or contact thermal device as per clinical protocol.  For the purpose of this clinical 
investigation, clips should not be used unless there is no alternative.  Patients treated with clips 
prior to their final pass colonoscopy, will be withdrawn from the investigation. 
Physicians may also withdraw any patient due to medical causes if deemed appropriate, including 
patients that have undergone at least one (1) procedure. 
 
6.2 
Investigational Device(s) and Comparator(s) 
Each subject will undergo back-to-back tandem colonoscopies, which could last approximately up 
to one (1) hour each.  It is possible that procedures that have multiple therapeutic interventions may 
go beyond the expected time frames. 
The Aer-O-Scope Colonoscope System will be compared to standard conventional colonoscopes 
that are normally used at the study sites (see Appendix 2 for the exact scope models). This study is 
intended to compare visualization properties of the currently used technologies; therefore, the 
standard colonoscope was chosen as the comparator. 
During the course of this investigation, subjects will undergo the standard (split) bowel preparation 
used for colonoscopy at the clinic.  This may include but may not be limited to one of the following 
medications: 
• 
MoviPrep 
• 
Picolax 
• 
Miralax 
• 
Motilium 
• 
Laxadine 
• 
Golytely 
 
During the course of this investigation, subjects will undergo the standard sedation given for 
colonoscopy.  This may include but is not limited to the following medications: 
• 
Biatryl/Fentanyl 
• 
Dormicum/Medazolam 
• 
Propofol 
 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
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Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
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During the course of this investigation, subjects who have findings during their colonoscopies will 
undergo polypectomies and/or biopsies and/or tattooing using standard therapeutic tools.  This may 
include but is not limited to the following therapeutic tools and medications: 
Biopsy forceps – both hot and cold 
• 
Snare – both hot and cold 
• 
Needle – for tattooing or injecting  
• 
Saline solution 
• 
Tattooing ink 
• 
Epinephrine 
• 
Argon plasma coagulation 
• 
Cautery forceps/needles 
The number of polyps detected during the second pass colonoscopy (that were not removed or 
tattooed during the first pass) will represent the overall number of missed polyps for the first 
colonoscopy. The number of detected polyps is defined as the number of polyps detected during 
colonoscopy. Each polyp removed (regardless of first or second pass colonoscopy) will be sent to 
histology as a singular specimen. Histology will determine if the lesion removed is an adenoma, 
hyperplastic polyp, serrated adenoma, cancer etc.  
Patients with polyps ≥20mm detected during 1st pass with conventional colonoscopy will be 
withdrawn from the study. Patients with polyps ≥20mm detected during 1st pass with the Aer-O-
Scope will be tattooed for polyp resection during the 2nd pass with a conventional colonoscope. 
Patients with polyps ≥20mm that were missed during a 1st pass with a conventional colonoscope 
and detected with the Aer-O-Scope will be tattooed and undergo a 3rd pass with a conventional 
colonoscope for polypectomy/EMR (endoscopic mucosal resection).  
Upon determination of polyp histology, the NMA will be calculated for each procedure. The NMA is 
defined as the number of adenomas detected during the second pass colonoscopy and confirmed 
histologically, that were not removed (or tattooed) during the first pass colonoscopy. The NMA will 
be calculated for both cohorts alike.  The AMR will then be calculated for each cohort. 
In the event pathology that is too large to remove or in a location preventing endoscopic removal is 
visualized during the course of any procedure, the pathology will be marked using tattooing. In the 
event a lesion is too large to remove during second pass colonoscopy with the Aer-O-Scope 
Colonoscope System but can be removed endoscopically with a conventional colonoscope, the 
pathology will be tattooed and the subject will undergo a third procedure with a conventional 
colonoscope using the same bowel prep and sedation, to remove the said pathology.  Pathologies 
of this type will not be considered missed by the Aer-O-Scope. 
The Aer-O-Scope Disposable Scanner is a single use disposable device.  Each subject will undergo 
a colonoscopy with a single Aer-O-Scope Disposable Scanner (heretofore “scanner”).  In the event 
of a technical malfunction, the scanner will be replaced with a new one. The expected number of 
Aer-O-Scope Disposable Scanners to be used is 310 but more may be used in the event of device 
malfunction. Each subject will undergo a conventional colonoscopy with a conventional 
colonoscope.  The conventional colonoscope is a reusable device that undergoes high level 
disinfection / reprocessing between procedures.  Each clinic generally uses three (3) scopes per 
procedure room.  One (1) scope in use, another awaiting the next procedure and the third in 
reprocessing. Three (3) sites will be participating in this clinical investigation; therefore, the number 
of conventional colonoscopes to be used is expected to be 9; however, more or less may be used 
according to the sites’ standard operational procedures.   
Disposable and reusable therapeutic instruments will be used as needed. 
An interim analysis will be performed upon completion of each study site. 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
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6.3 
Subjects 
Subject Selection 
Inclusion Criteria: 
 
1. Subject is indicated for screening, diagnostic (minor complaints such 
as rectal bleeding or minor abdominal pain) or surveillance 
colonoscopy 
2. Subject willing to undergo tandem colonoscopies with Aer-O-Scope 
Colonoscope and a conventional colonoscope (including a single 
colon preparation bowel cleansing)  
3. Subject between the ages of 45 and 75 (patients between the ages of 
45 and 50 must have a family history of a first degree relative with 
onset of colon cancer before the age of 60). 
4. Subject is able to understand and willing to sign informed consent 
form 
Exclusion Criteria: 
 
1. Personal 
history 
of 
colorectal 
neoplasia 
including 
familial 
adenomatous polyposis or hereditary nonpolyposis, colon cancer 
(HNPCC). 
2. Diagnosis of active (flaring) inflammatory bowel disease (active 
ulcerative colitis or Crohn’s colitis), bowel obstruction, or acute 
diverticulitis, or known severe diverticulosis, fecal incontinence or any 
known large-bowel disease that would require a predetermined 
therapeutic colonoscopy (non-screening, non-diagnostic or non-
surveillance cases) 
3. Severe gastrointestinal tract-related symptoms, or complaints, 
suggesting performance of a pre-determined therapeutic colonoscopy 
(non-screening, non-diagnostic or non-surveillance cases) 
4. History of colonic resection 
5. Clinically significant cardiovascular or pulmonary disease  
6. Cancer or other life threatening disease or significant chronic condition 
that puts the subject at risk. 
7. Blood-clotting 
disorders 
and/or 
current 
anticoagulant 
therapy 
(Subjects taking up to 100mg aspirin for prophylactic treatment are 
acceptable for this study) 
8. Pregnancy 
9. Previous radiation therapy to the abdomen  
10. Morbid Obesity (BMI > 40 kg/m2) 
11. Drug abuse or alcoholism 
12. Subject is bed-ridden and/or unable to adequately communicate  
13. Subject is under custodial care 
14. Subject  has  a  history of  psychiatric  disorders  which  would prevent 
compliance with study instructions 
15. Participation in a clinical study within the previous 30 days 
 
Withdrawal 
Subjects will be removed from the study whenever it is necessary to 
safeguard their welfare.  Non-compliance with the protocol or occurrence 
of serious adverse events may also necessitate discontinuation from the 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
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study.  When a patient is removed from the study, a final physical 
examination must be performed.  Subjects removed from the study 
because of an adverse event will be followed-up until the adverse event 
has resolved. 
Additional reasons for removing a patient from the study: 
1 
Subjects who express a desire to withdraw from the study. 
2 
Any medical condition that, in the opinion of the investigator, warrants 
discontinuation from the study for the safety of the patient. 
3 
Poor colonic bowel cleansing that prevents proper visualization and 
intubation of the colon. 
4 
A large (≥20mm) polyp removal during first pass colonoscopy with a 
conventional colonoscope 
5 
Use of clips during first pass colonoscopy with a conventional 
colonoscope 
Point of Enrollment 
Subjects will meet with the physician or physician appointed 
representative (such as a clinical coordinator) and be given ample 
opportunity to read and review the provided informed consent form and 
will be asked to sign prior to the beginning the bowel cleansing regimen.  
Subjects will be given the opportunity to ask the physicians questions 
prior to signing the informed consent. Subjects unable to sign prior to the 
day of procedure will be asked to sign the patient informed consent prior 
to entering the procedure room.  A signed copy of the form will be 
provided for each patient. 
Duration 
This multi-center, multi-national study is expected to last no longer than 
twelve (12) months.  Each subject will be enrolled, undergo Aer-O-Scope 
Colonoscopy and conventional colonoscopy and be followed 24-48 hours 
via telephone post procedure. Subjects undergoing therapeutic 
interventions will be followed until the final histological results and only 
then will be terminated from the study. 
Number of Subjects 
This study will include a total of 310 subjects in three (3) sites.  Each site 
will study up to between 100 and 110 subjects (depending on the number 
of sub-investigators undergoing training).  Subjects will be enrolled over a 
three (3) month period at each site and will undergo procedures over a 
three (3) month period at each site. 
 
6.4 
Procedures 
Procedures  
Subjects indicated for screening, diagnostic (for minor complaints such as 
rectal bleeding or minor abdominal pain) or polyp surveillance 
colonoscopy will meet with the physician or clinical coordinator prior to 
the procedure for a standard pre-procedure evaluation.  Following a 
preliminary evaluation of eligibility, the patient will be informed of the 
clinical study and offered the opportunity to participate if he/she is an 
acceptable candidate. Should the subject agree to join the study, they will 
be provided a copy of the patient informed consent form and provided 
ample time to review the form. The point of enrollment will be upon 
signing the patient informed consent form. Subjects who sign the consent 
form but do not undergo any procedure will be recorded as screen 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
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failures on a separate log, and removed from the enrollment roster.  
The duration of this multi-national study is expected to be twelve (12) 
months, three (3) months per site.  Each enrolled subject will participate 
for up to seven (7) days which will include the day of the informed 
consent signature, the bowel preparation and the day of procedures (Aer-
O-Scope Colonoscopy and colonoscopy) with a 24-48 hour follow-up 
period. 
Up to 200 subjects will be enrolled in the USA and up to 110 subjects will 
be enrolled in Israel with a total of up to 310 Subjects overall. 
6.5 
Monitoring plan 
General Outline 
Details 
A full monitoring plan 935CLD Clinical Investigation Monitoring Plan will 
be provided separately. 
7 
STATISTICAL CONSIDERATIONS 
Measurements  
The pass criteria for the study objectives are rejecting the Null 
hypotheses as presented below.  
Primary Hypothesis: 
 
Colonoscopy with the Aer-O-Scope Colonoscope System will have lower 
AMR than the conventional forward-viewing colonoscopes. 
Statistical Analysis  
Assumptions:  
 
 
• 
The Adenomas rate within the sample will be 50% (see Appendix 4: 
Bibliography). 
• 
The adenoma rate in the sample, for patients with Adenomas, will be 
200% (average of 2 adenomas per person). (see Appendix 4: 
Bibliography) 
• 
The differences in AMR between the two groups will be 15% (see 
Appendix 4: Bibliography) 
• 
The expected AMR of the two groups will be 0.10 vs 0.25 (see 
Appendix 4: Bibliography) 
• 
The drop-out rate will be 10%.  
Statistical Analysis 
Plan:  
Hypotheses testing 
based calculations 
 
• 
For testing the hypothesis that the Aer-O-Scope Colonoscope 
System will have lower AMR and PMR than the conventional 
forward-viewing colonoscopies we will perform the Z-tests for 
comparing two proportions. The tests will be two-sided with 
significant level of 5%.  
• 
To demonstrate the physicians proficiency in operation of (including 
therapeutic interventions) and visualization with the Aer-O-Scope 
Colonoscope descriptive statistics will be performed using the Likert 
Scale questionnaire. A mean score between one (1) and three (3) will 
denote proficiency. 
Sample Size 
Calculation: 
 
The sample size calculation based on the independence AMR between 
the two groups. A total of 240 patients are needed to compare the AMR 
between the groups using Z-test for two proportions comparisons. This 
number enables a 10% dropout, and does not include 70 patients (20-30 
training subjects per site (sub-investigator dependent) for learning 
qualification. This sample size based on a significant level of 5% and a 
power of 80% to prove a difference in AMR between the groups. 
 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
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8 
DATA MANAGEMENT 
Procedures 
Description 
SOP CLP688 Processing Paper CRF Received from Investigational Sites 
describes activities related to data processing and data management.  
Overall responsibilities as stated in the SOP are as follows: 
The Sponsor of the clinical investigation is responsible for: 
• 
Maintaining records to document the compliance of all parties 
involved in the clinical investigation 
• 
Ensuring that the clinical investigation is correctly monitored at the 
investigation site according to the monitoring plan 
The Monitor is responsible for: 
• 
Monitoring the clinical investigation at the investigation site, 
according to 934CLD Clinical Investigation Monitoring Plan and 
SOP 633CLP Monitoring Clinical Investigations, ensuring that: 
o 
CRFs and queries are complete, recorded in a timely 
manner, and consistent with source documents 
o 
Appropriate corrections, additions or deletions are made to 
the CRFs, dated, explained if necessary and initialed by the 
principal investigator or by his/her authorized designee 
• 
Maintaining detailed shipping records for transmission of 
completed paper CRFs to Sponsor / CRO 
The Principal investigator (PI) for the clinical investigation is 
responsible for: 
• 
Ensuring the accuracy, completeness, legibility and timeliness of 
the data reported to the sponsor in the CRFs and in all required 
reports during the clinical investigation 
• 
Supporting the sponsor or CRO and responding to questions 
during monitoring and close-out of the clinical investigation at the 
investigation site 
The Site Clinical Coordinator for the clinical investigation is responsible 
for: 
• 
Maintaining all of the study related hospital files 
o 
This includes maintaining all logs such as: 
 
Clinical Investigation Plan (CIP) Deviation Log 
 
Subject Informed Consent (SIC) Signature Log 
 
Investigation Team Log 
 
Device Accountability Log 
 
Investigation Site Team Training Log 
 
Clinical Investigation Document Approval Log 
 
CIP Amendment Log 
• 
Correct filling of the CRFs based on source documentation and 
live documentation 
• 
Maintaining contact with study subjects, and coordinating visits to 
the hospital for signing documents and undergoing treatment 
• 
Providing the subjects with the bowel cleanse preparation 
medications (sponsor provided) 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
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• 
Instructing subjects on proper diet and other study related issues 
• 
Ensuring 24-48 hour follow-up phone calls are made 
• 
Maintaining contact with the sponsor for all reportable incidents 
and general updates 
The Data Manager is responsible for: 
• 
Managing CRF receipt and reconciliation of any discrepancies 
prior to data entry 
• 
Performing manual review of the CRF to verify completeness and 
legibility, data content and consistency 
• 
Ensuring that all SAEs have been reported to the Sponsor 
• 
Performing CRF data entry into the clinical data base 
• 
Maintaining the CRF Tracking Form (689CLP), recording data 
receipt & reconciliation, manual review, data changes, data 
queries and data entry 
Retention Period 
All original copies of CRFs and completed forms will be stored in the Trial 
Master File in accordance with 674CLP Trial Master File Management for 
a period of no less than five (5) years. 
Clinical Quality 
Assurance 
Study File Monitoring 
• 
Prior to study implementation, a monitoring schedule will be set 
and logged into the 642CLP Monitoring Schedule Form.  Tracking 
of planned and actual visits will also be performed using this form. 
• 
At the start of the clinical study, the Clinical Monitor will monitor 
the study files for the following: 
o 
IRB/EC/Helsinki Committee Documents 
 
All IRB Correspondence is on file 
 
The study staff are IRB approved prior to performing any 
study procedures 
 
Adverse events and deviation procedures for reporting 
to IRB per current guidelines are in place 
 
All versions of the IRB protocols and informed consent 
forms are on file 
o 
FDA  
 
Signed Good Clinical Practice compliance form, financial 
disclosure and CV for the PI and sub investigators 
 
All FDA correspondence, if applicable  
 
Procedures of documentation of serious adverse events 
that are unexpected and related for reporting to FDA 
within 7 calendar days are in place 
• 
Other documents: 
o 
CVs for all study staff are on file and updated within the last 2 
years 
o 
Medical licenses for the Sub-Investigators are on file and 
updated prior to expiration 
o 
Delegation Log is updated and procedures for updating the 
log with new staff are in place 
o 
All other essential documents have been prepared and 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
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completed as appropriate 
Before, during and at the close of the study period, study documentation 
will be monitored by the Clinical Monitor for the following: 
• 
Informed Consent  
• 
Ensure that subject identification is on all pages of the ICF, if 
applicable 
• 
Documentation of subject receiving a copy of the consent form is 
present 
• 
Clinic note documents informed consent process 
• 
The subject and study representative signed and dated the 
consent form for him/herself  
• 
The subject initialed and dated all appropriate pages on the 
informed consent form, if applicable 
• 
 Note to file completed for any informed consent deviations.   
• 
Ensure a valid (current version date) copy of the consent form 
was used 
Protocol: 
• 
Confirm that the study staff is conducting the study in compliance 
with the protocol approved by IRB/CE/Helsinki Committee and if 
applicable, FDA. 
• 
The 
protocol 
deviations 
(exceptions 
and 
violations) 
are 
documented in the subject chart and reported to IRB/CE/Helsinki 
Committee as required. 
• 
Ensure any deviations are logged in FORM 638CLP CIP 
Deviations 
Source Documents: 
• 
Review subject charts to ensure accuracy, completeness and 
legibility of the data 
• 
Any correction made to the source documents is dated, initialed, 
and explained. The original entry should not be obscured. 
• 
The protocol specific source documents are on file. 
• 
Source documents are completed in ink. 
• 
Note to files are generated for missing or incomplete data, and to 
explain any discrepancies or additional comments. 
Case Report Forms: 
• 
Ensure that the data reported on the CRF is consistent with the 
source documents. 
• 
Discrepancies between the source documents and CRF are 
explained in a note to file or captured in a comment in the CRF. 
 
Query Management  
Queries may be generated by the PI, Sub-investigators, Sponsor, Monitor 
or Data Center. 
Query management will be handled by the Clinical Monitor using the 
639CLP CRF & Query Monitoring Log. 
The Clinical Monitor will create a Monitoring Report using the 637CLP 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
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Monitoring Report FORM. 
Samples of data queries are as follows: 
• 
Non-compliance to protocol 
• 
Missing data 
• 
Out-of-range data 
• 
Unplanned patient visits 
• 
Data inconsistent with the source documents 
• 
Data clarification 
 
9 
AMENDMENTS TO THE CIP 
Amendments 
All subsequent amendments to the CIP must also be agreed and 
approved by the sponsor, the coordinating investigator and all principal 
investigators. 
The Sponsor / CRO will ensure that  
9.1 
Amendments to the Clinical Investigation Plan are documented, 
using form 698CLP ‘CIP Amendment and Revision Sheet’ 
9.2 
approval is documented, using form 693CLP ‘Clinical Investigation 
Document Approval Log’’ 
9.3 
the amended CIP is sent to all investigators and the IRB / EC after 
approval 
 
10 DEVIATIONS FROM CLINICAL INVESTIGATION PLAN 
Deviations 
Neither the Principal Investigator nor any of the sub-investigators are 
authorized to deviate from the CIP, except as specified in 4.5.4 b of ISO 
14155:2011 and 21 CFR 812.150 (a)(4), specifically requests for 
deviations, and reports of deviations, if the deviation affects subject’s 
rights, safety and wellbeing, or the scientific integrity of the clinical 
investigation. 
Under emergency circumstances, deviations from the CIP to protect the 
rights, safety and well-being of human subjects may proceed without prior 
approval of the sponsor and the EC/IRB/Helsinki Committee. Such 
deviations shall be documented and reported to the sponsor and the 
EC/IRB/Helsinki Committee as soon as possible. 
Procedures 
According to 633CLD Monitoring Clinical Investigations, after completion 
of the monitoring visit, the monitor will prepare the EC/IRB /Helsinki  
Committee Notifications letter using form 644CLP EC Notification Form if 
any reportable serious deviations or adverse events were recorded, and 
send them to the Ethics Committee/Institutional Review Board/Helsinki 
Committee and Principal Investigator, according to this CIP. 
Notifications 
All notifications will be carried out within the time frames specified by 
local regulatory authorities or as noted in 934CLD Clinical Investigation 
Monitoring Plan (for this CIP) 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
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Other 
Investigational site activities will be monitored prior to, throughout, and 
following the conduct of the clinical investigation to ensure that all criteria 
are met as per this Clinical Investigation Plan. 
In the event that responsibilities are not met by participating personnel, 
the sponsor reserves the right to disqualify the specific parties involved, 
specifically the Principal Investigator, as follows: 
• 
Accuracy, completeness, legibility and timeliness of the data 
reported to the sponsor in the CRFs and in all required reports 
during the clinical investigation are not carried out or are 
compromised 
• 
Resources are not provided in order to facilitate the operation of 
the investigational study 
• 
Any unethical actions related to the investigation and/or serious 
deviations from the CIP and/or written procedures 
In the event that monitoring activities reveal any areas of concern, the PI 
will be notified in writing and corrective actions will be established.  
Should the event occur repeatedly, the PI/Site may be disqualified. 
 
11 DEVICE ACCOUNTABILITY 
procedures for 
accountability of 
investigational 
devices 
690CLP Device Inventory & Accountability describes all procedures for 
device shipping, accountability, storage, use and return. 
Responsibilities are as follows: 
The Sponsor of the clinical investigation is responsible for: 
• 
Maintaining records to document the compliance of all parties 
involved in the clinical investigation 
• 
Keeping records to document the physical location of all 
investigational devices from shipment of investigational devices to 
the investigation sites until return or disposal 
• 
Monitoring clinical activities at the investigation site according to 
the monitoring plan, to ensure that investigational device 
accountability records are accurate and complete 
The Principal investigator (PI) for the clinical investigation is 
responsible for: 
• 
Keeping records documenting the receipt, use, return and 
disposal of the investigational devices at the site 
• 
Supporting the sponsor or CRO and responding to questions 
during monitoring and close-out of the clinical investigation at the 
investigation site 
 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
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12 STATEMENTS OF COMPLIANCE 
12.1 This clinical investigation will be conducted in accordance with ethical principles stated in the 
Declaration of Helsinki and in compliance with all national and local regulatory requirements 
for the safety and protection of human subjects.  
12.2 This clinical investigation will be implemented only upon receiving all final 
notification/authorizations from local and national regulatory and Helskinki/EC/IRB 
authorities, as appropriate. 
12.3 This clinical investigation will comply with any additional requirements set forth by the 
Helsinki/EC/IRB and/or regulatory authorities. 
12.4 This clinical investigation provides clinical study medical insurance for study participants as 
required by local and national regulatory authorities. 
 
13 INFORMED CONSENT PROCESS 
General process 
Subjects interested in participating in the clinical investigation will be 
screened by the clinical coordinator or participating physician. 
Subjects who meet the criteria will then be given a copy of the Patient 
Informed Consent prior to receiving the medication for the bowel prep, 
with ample time to read and review the document and ask questions prior 
to signing. 
Subjects will meet with one of the investigators or the clinical coordinator 
to discuss investigational participation and any questions they may have 
regarding the investigation, the investigational device and the informed 
consent. 
The informed consent will be signed during the meeting with one of the 
participating investigators. 
A photocopy of the signed patient informed consent form will be provided 
to the patient prior to the procedure. 
Subjects requesting to withdraw consent will be disqualified from the 
investigation at no cost or consequence. 
Unable subject 
Subjects unable to provide consent on their own behalf will not be 
recruited into the study. 
Emergency treatment 
In the event of an emergency resulting from the clinical investigation, all 
emergency treatment will be provided at no cost to the patient.  Clinical 
Investigation Insurance has been provided to ensure all costs be covered 
if necessary. 
 
 
 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
934cld Rev 03 Aos Visualization Comparitive Study_2017 Mar 19  
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14 ADVERSE EVENTS, ADVERSE DEVICE EFFECTS AND DEVICE DEFICIENCIES 
Definitions 
An adverse event is any undesirable or unintentional or unexpected 
event (sign, symptom, illness, abnormal laboratory value, or other 
medical event) that occurs during the course of the study, whether or not 
considered related to the device. This definition includes events related to 
the investigational medical device or the comparator and also includes 
events related to the procedures involved.   
Regardless of the relationship to the investigational device, all moderate 
to serious adverse events occurring from the time that the informed 
consent is signed must be recorded in the patient’s CRF. Mild expected 
adverse events such as flatulence, nausea, diarrhea, bloating, mild 
abdominal cramping, anal discomfort, minor rectal bleeding (specifically if 
therapeutic intervention is performed), headache, dizziness, thirst, 
tenesmus or any other symptoms not requiring treatment will not be 
recorded.  These events are common and expected. For device 
operators, this definition is restricted to the events related to the 
investigational medical device.  
A mild adverse event is one that the symptoms are barely noticeable to 
the patient. It does not influence performance, require drug treatment or 
prevent the patient from carrying on with normal life activities. 
A moderate adverse event is one that the symptoms make the patient 
uncomfortable and causes some impairment to normal life activities and 
requires treatment for symptom(s). 
A serious adverse event an adverse event that: 
• 
Led to death, 
• 
Led to serious deterioration in the health of the subject, that either 
resulted in 
o 
A life-threatening illness or injury, or 
o 
A permanent impairment of a body structure or body function, 
or 
o 
In-patient or prolonged hospitalization, or 
o 
Medical or surgical intervention to prevent life-threatening 
illness or injury or permanent impairment to a body structure 
or a body function 
An adverse device effect (ADE) is an event related to the use of an 
investigational medical device.  This includes any adverse event resulting 
from the insufficiencies or inadequacies in the instructions for use, the 
deployment, the implantation, the installation, the operation or any 
malfunction of the investigational medical device.  This also includes user 
error or intentional misuse of the investigational medical device. 
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. 
An unanticipated serious adverse device effect (USADE) 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 / 
Investigator’s Brochure.  
Principal Investigator  
The principal investigator will notify the sponsor immediately (within 24 
hours) of any serious adverse event or serious adverse device effect and 

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GI View Ltd. 
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within 48 hours for any other adverse device effect.  All reports to the 
appropriate authorities will be made by the principal investigator as set 
forth in the standard clinical   practices outlined   in   the   21 CFR (§ 
812.150(a)(1), § 812.46(b) and § 812.150(b)(1))/ MEDDEV 2.7/3 Dec 
2010 and ICH-GCP Guidelines. 
Adverse Events 
Report 
Adverse Events will be reported and treated as per the standard clinical  
practices outlined   in   the   21 CFR (§ 812.150(a)(1), § 812.46(b) and § 
812.150(b)(1))/ MEDDEV 2.7/3 Dec 2010 and ICH-GCP Guidelines. 
Device Deficiencies 
Report 
All device deficiencies related to the identity, quality, durability, reliability, 
safety or performance of the investigational medical device shall be 
documented throughout the clinical investigation and appropriately 
managed by the sponsor. 
Foreseeable Adverse 
Events and 
Anticipated Adverse 
Device Effects 
Anticipated adverse events include minor bloating, stomach ache, 
flatulence, nausea, vomiting, light headedness, minor mucosal erosions 
and rectal fissures.  Anticipated adverse device effects include problems 
related to the suction system that may hinder visualization, temporary 
irrigation problems due to kinks in the tubing resulting from a tortuous 
colon etc. 
Emergency Contact 
Details 
In the event of a serious adverse event and/or a serious adverse device 
effect, the following sponsor representative should be contacted 
immediately: 
Sharon Goldfarb-Albak 
VP Regulatory and Clinical 
Tel: +972-54-6454034 (24hours a day, 7 days a week) 
Email: Sharon@giview.com 
Fax: +972-73-2539666/7 
Data Monitoring 
Committee  DMC 
An independent data safety emonitoring board (DSMB) of at least three 
(3) gastroenterologists will review any and all adverse events and device 
deficiencies.  Chairing the committee will be Dr. TBD. 
 
15 VULNERABLE POPULATION 
15.1 This clinical investigation will be conducted on adult populations only.  No vulnerable 
populations such as children and/or pregnant females etc. will be included in the study 
population. 
 
16 EARLY TERMINATION OR SUSPENSION OF THE CLINICAL INVESTIGATION 
Suspension or 
Premature 
Termination 
Grounds for suspension or premature termination of the clinical 
investigation include but are not limited to: 
Non compliance of the investigational site personnel to the CIP and or 
investigational procedures 
Severe Adverse Events that demonstrate danger to the patient 
population 
Unethical performance on the part of any of the investigators 
Device Adverse Effects that demonstrate danger to the patient population 
or severe flaw in investigational device design 
Failed audit of investigation with serious flaws to study design, 

Clinical Investigational Plan 
Protocol ID 
934CLD 
Sponsor 
GI View Ltd. 
Revision 
03 
Investigational 
Device 
Aer-O-Scope® 
Colonoscope 
System  
 
 
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performance or outcomes 
Business/Financial issues that cannot be resolved 
Other unforeseen events that give the PI/Sponsor reasonable doubts to 
the safety and/or performance of the system which will be referred to the 
Data Safety Monitoring Committee for review prior to determination of 
suspension or termination. 
Blinding/Masking 
Technique 
This clinical investigation does not include any blinding or masking. 
Follow-Up 
Patients will be followed up 24-48 hours post procedure via telephone by 
the clinical coordinator at each site. Patients who undergo therapeutic 
interventions will only be terminated from the study upon receiving the 
histology results. 
 
17 PUBLICATION POLICY 
The results of this clinical investigation may be published in a mainstream peer reviewed 
professional journal pending prior written approval from GI View Ltd. 
 
18 BIBLIOGRAPHY 
Bibliographic 
References 
A detailed bibliography can be found in Appendix 1 of the Investigator’s 
Brochure (936CLD Rev 01). Articles mentioned in this CIP can be found 
in the endnotes at the end of this document. 
 
 
 

Clinical Investigational Plan 
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Sponsor 
GI View Ltd. 
Revision 
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Appendix 1: Participating Investigators 
1. Dr. Erwin Santo 
2. Dr. Nathan Gluck 
3. Dr. Sharon Levy (potential sub-investigator)1 
4. Dr. Mati Shnell (potential sub-investigator) 
5. Dr. Adam Philips (potential sub-investigator) 
6. Dr. Guy Rosner (potential sub-investigator) 
7. Dr. Roi Dekel (potential sub-investigator) 
8. Dr. Yami Shapira (potential sub-investigator) 
 
                                           
1 There will be two (2) sub-investigators at the TLVMC site.  This list contains the 
potential candidates for participating as sub-investigators in this study, pending final 
agreements. 

Clinical Investigational Plan 
Protocol ID 
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Sponsor 
GI View Ltd. 
Revision 
03 
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Appendix 2: Conventional Colonoscopes Used in this Investigation 
All colonoscopes used in the TLVMC site will be of the latest models and have HD visualization 
systems 
 

Clinical Investigational Plan 
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Sponsor 
GI View Ltd. 
Revision 
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Appendix 3: Therapeutic Accessories Used in This Study 
See IMOH Form 1B 
 

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Sponsor 
GI View Ltd. 
Revision 
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Appendix 4: Bibliography 
 
                                           
i N Gluck et al; A novel colonoscope with panoramic visualization detected more 
simulated polyps than conventional colonoscopy in a live swine model; Endoscopy 
International Open 2015 
ii  IM Gralnek et al; Standard forward-viewing colonoscopy versus full-spectrum 
endoscopy: an Internation, multicentre, randomized, tandem colonoscopy trial; 
Lancet Oncol 2014; 15: 353–60 
iii Siersema PD et al. Retrograde-viewing device improves adenoma detection rate; 
World J Gastroenterol 2012 July 14; 18(26): 3400-3408 
iv AM Leufkens et al; Effect of a retrograde-viewing device on adenoma detection rate 
during colonoscopy: the TERRACE study; Gastrointest Endosc 2011;73:480-9 
v Gluck Nathan et al. A novel colonoscope with panoramic visualization detected more 
simulated polyps than conventional colonoscopy in a live swine model;Endoscopy 
International Open; DOI http://dx.doi.org/10.1055/s-0034-1393080; Published 
online: 2015