Evaluation of Safety, Usability and Subject Compliance While Using Check- Cap's C-Scan System for Providing Structural Information on Colonic Polypoid Lesions and Masses
Phase: NA
Conditions: Colo-rectal Cancer
Sponsor: Check-Cap Ltd.

 
 
Document Title 
Clinical Investigational Plan For Study CL-SY-02-0096 
 
Document No. 
DOC001593  
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Clinical Investigational Plan 
 
 
 
CHANGE HISTORY 
Rev. number 
Change Owner 
Change description 
01 
Shlomo Lewkowicz 
 
DCO0023 
Initial Release 
02 
Michal Nachmanovich 
DCO0039 
Sponsor Address. 
Exclusion Criteria update.  
Low X-ray body dose revision. 
Anticipated Adverse events revision 
03 
Shlomo Lewkowicz 
 
ECO-19-000031 
US Pilot study lowering BMI 19 
 
 
 
 
AUTHORIZATION 
 
Name 
Title 
Date 
Signature 
Author 
Michal Nachmanovich 
Clinical Research Associate 
See Arena 
See Arena 
Reviewer 
Shlomo Lewkowicz 
Clinical Affairs Director 
See Arena 
See Arena 
Approver 
Israel Hershko 
Q&R Director 
See Arena 
See Arena 
 
 
 
PROPRIETARY INFORMATION 
© Copyright Check-Cap, Ltd. All rights reserved. Proprietary. CONFIDENTIAL. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Clinical Investigational Plan 
Study: CL-SY-02-0096 
Study Protocol DOC. No.: DOC001593 
 
EVALUATION OF SAFETY, USABILITY AND SUBJECT COMPLIANCE WHILE USING CHECK-CAP’S C-SCAN 
SYSTEM FOR PROVIDING STRUCTURAL INFORMATION ON COLONIC POLYPOID LESIONS AND 
MASSES 
 
Study device:  
 
Check Cap study #:
 
Phase:  
Clinical evaluation: pre-market safety, usability, and subject compliance 
 
Sponsor: Check-Cap US Inc 
135 South Lasalle 
Suite 4000 
Chicago, Illinois 60603 
 
On behalf of its client:  
Check-Cap Ltd. 
29 Abba Hushi Ave.  
P.O. Box 1271  
Isfiya, Israel 3009000 
 
 
Correspondent: 
Israel Contact for Check Cap Inc. 
 
 
 
Shlomo Lewkowicz, D.Sc. 
 
 
 
Clinical Director 
 
 
 
29 Abba Hushi Ave 
P.O. Box 1271 
Isfiya 3009000,   Israel 
E-mail: shlomo.lewkowicz@check-cap.com 
Office +972 4 8303401    Mobile +972-52-4747234 
 
US Contact:  
?? 
NAMSA 
 
Principal Research Manager, Regulatory ?? 
400 Highway 169, Suite 500 
Minneapolis, MN 55426 
Mobile: 1-612-968-9567 
Email: ?? 
 
CRO:  
 
Pamela Wolfe, MS, MBA, CCRP 
 
 
 
Principal Medical Research Manager 
NAMSA 
400 Highway 169, Suite 500 
Minneapolis, MN 55426 

 
 
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Mobile: 1-763-258-7027    Email: pwolfe@namsa.com 
 
 

 
 
Document Title 
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1 
TABLE OF CONTENTS 
2 
STATEMENT OF COMPLIANCE .............................................................................................. 7 
3 
CLINICAL INVESTIGATION PLAN APPROVAL .......................................................................... 8 
4 
CLINICAL INVESTIGATION SUMMARY ................................................................................... 9 
5 
SCHEDULE OF STUDY ASSESSMENTS ................................................................................... 11 
6 
ABBREVIATIONS .................................................................................................................. 12 
7 
INTRODUCTION ................................................................................................................... 13 
7.1 
Colorectal Cancer Screening ..................................................................................................................... 13 
7.2 
C-Scan Technology .................................................................................................................................... 13 
8 
PREVIOUS STUDIES.............................................................................................................. 15 
8.1 
Clinical Study Protocol C-SY 00093 ........................................................................................................... 15 
8.2 
Laboratory Tests ....................................................................................................................................... 16 
8.2.1 
Image Reconstruction .............................................................................................................................. 16 
8.2.2 
Polyp Detection ....................................................................................................................................... 16 
8.2.3 
Biocompatibility ....................................................................................................................................... 16 
8.2.4 
Animal Studies: ........................................................................................................................................ 17 
9 
INVESTIGATIONAL DEVICE ................................................................................................... 18 
9.1 
Device Description.................................................................................................................................... 18 
9.1.1 
C-Scan System Components .................................................................................................................... 18 
9.1.2 
Radio Frequency (RF) Wrist Watch .......................................................................................................... 19 
10 STUDY OBJECTIVES .............................................................................................................. 20 
10.1 
Primary Objectives ................................................................................................................................... 20 
10.2 
Secondary Objectives ............................................................................................................................... 20 
10.3 
Primary Safety Outcome Measure ............................................................................................................ 20 
10.4 
Secondary Outcome Measures ................................................................................................................. 20 
11 STUDY DESIGN .................................................................................................................... 21 
11.1 
Overall Design .......................................................................................................................................... 21 
11.2 
Study Duration ......................................................................................................................................... 21 
12 SUBJECTS ELIGIBILITY .......................................................................................................... 22 
12.1 
Study Population ...................................................................................................................................... 22 

 
 
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12.2 
Inclusion Criteria ...................................................................................................................................... 22 
12.3 
Exclusion Criteria ...................................................................................................................................... 22 
12.4 
Withdrawal Criteria .................................................................................................................................. 23 
13 STUDY PROCEDURES AND SCHEDULE .................................................................................. 24 
13.1 
Study Procedures ..................................................................................................................................... 24 
13.2 
Study Documentation............................................................................................................................... 26 
13.3 
Prescreening ............................................................................................................................................. 26 
13.4 
Informed Consent Process ........................................................................................................................ 26 
13.5 
Visit 1: Baseline ........................................................................................................................................ 26 
13.5.1 
C-Scan Procedure ..................................................................................................................................... 27 
13.6 
Follow-Up 1 .............................................................................................................................................. 27 
13.6.1 
FIT Procedure ........................................................................................................................................... 27 
13.6.2 
Capsule Progress Days: Contrast Ingestion, Laxatives and Non-Soluble Fiber ........................................ 27 
13.6.3 
Subject Diary ............................................................................................................................................ 27 
13.6.4 
Follow-Up Phone Calls ............................................................................................................................. 27 
13.7 
Follow Up 2: Capsule excretion and collection ......................................................................................... 28 
13.7.1 
Capsule Return ......................................................................................................................................... 28 
13.7.2 
Usability Questionnaire ........................................................................................................................... 28 
13.8 
Follow-Up 3: Post-Colonoscopy Procedure ............................................................................................... 28 
13.9 
Unscheduled Visit(s) ................................................................................................................................. 28 
13.10 C-Scan Analysis ......................................................................................................................................... 28 
14 STATISTICAL ANALYSIS ......................................................................................................... 30 
14.1.1 
Sample Size Considerations ..................................................................................................................... 30 
14.1.2 
Primary Analysis Set ................................................................................................................................. 30 
14.1.3 
Operational Analysis Set .......................................................................................................................... 30 
14.1.4 
Data analysis ............................................................................................................................................ 30 
14.1.5 
Interim Review of Data ............................................................................................................................ 30 
15 SAFETY CONSIDERATIONS ................................................................................................... 31 
15.1 
Safety Parameters .................................................................................................................................... 31 
15.1.1 
Risks Associated with Participation In The Clinical Investigation ............................................................ 31 
15.1.2 
Potential Risk From The Capsule Procedure ............................................................................................ 31 
15.1.3 
Capsule Retention .................................................................................................................................... 31 
15.1.4 
Low X-Ray Body dose ............................................................................................................................... 33 
16 ADVERSE EVENTS ................................................................................................................ 34 
16.1 
Adverse Event Definitions ........................................................................................................................ 34 

 
 
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16.1.1 
Adverse Event .......................................................................................................................................... 34 
16.1.2 
Serious Adverse Event ............................................................................................................................. 34 
16.1.3 
Unanticipated Adverse Device Effect (UADE) .......................................................................................... 34 
16.1.4 
Device Malfunction/Failure ..................................................................................................................... 34 
16.2 
Anticipated Adverse Events ...................................................................................................................... 35 
16.3 
Recording and Documentation of Adverse Events .................................................................................... 35 
16.3.1 
Severity .................................................................................................................................................... 36 
16.3.2 
Relationship ............................................................................................................................................. 36 
16.4 
Safety Reporting Procedures .................................................................................................................... 36 
16.4.1 
Adverse Events Reporting ........................................................................................................................ 36 
16.4.2 
Serious Adverse Events Reporting ........................................................................................................... 36 
16.4.3 
Unanticipated Adverse Device Effect Reporting ...................................................................................... 36 
17 DATA COLLECTION AND QUALITY CONTROL ........................................................................ 37 
17.1 
Data Collection ......................................................................................................................................... 37 
17.2 
Data Monitoring ....................................................................................................................................... 37 
17.3 
Data Archiving .......................................................................................................................................... 37 
18 LABELING ............................................................................................................................ 38 
19 DELIVERY, STORAGE AND DISPOSITION ............................................................................... 39 
20 ETHICAL AND LEGAL ASPECTS ............................................................................................. 40 
20.1 
Ethical Committee Review and Approval .................................................................................................. 40 
20.2 
Ethical Conduct of the Study .................................................................................................................... 40 
20.3 
Subject Information and Consent ............................................................................................................. 40 
20.4 
Confidentiality .......................................................................................................................................... 40 
20.5 
Insurance .................................................................................................................................................. 40 
21 DISCLOSURE AND PUBLICATION OF INFORMATION ............................................................. 41 
22 REFERENCES ....................................................................................................................... 42 
23 APPENDICES: ....................................................................................................................... 43 
23.1 
ATTACHMENT 1: SUBJECT’S SATISFACTION QUESTIONNAIRE ................................................................... 44 
23.2 
ATTACHMENT 3: SUBJECT’S SATISFACTION QUESTIONNAIRE-COLONOSCOPY .......................................... 45 
 

 
 
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2 
STATEMENT OF COMPLIANCE 
 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), 21 CFR Parts 50, 56, 312, and 812 as applicable, any other 
applicable US government research regulations, and institutional research policies and procedures. The 
International Conference on Harmonization (“ICH”) Guideline for Good Clinical Practice (“GCP”) 
(sometimes referred to as “ICH-GCP” or “E6”) will be applied only to the extent that it is compatible with 
FDA and DHHS regulations. The Principal Investigator will assure that no deviation from, or changes to 
the protocol will take place without prior agreement from the sponsor and documented approval from the 
Institutional Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to the trial 
participants. All personnel involved in the conduct of this study have completed Human Subjects 
Protection Training. 
 
 

 
 
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3 
CLINICAL INVESTIGATION PLAN APPROVAL 
 
The undersigned confirm that they agree to conduct the study under the conditions described in this 
protocol. The investigator agrees to conduct this study in a manner that is consistent with good clinical 
practices and applicable laws and regulations for conducting clinical research. 
 
 
 
 
 
 
 
Investigator Signature 
 
Date 
 
 
 
 
 
 
Investigator Name (Printed) 
 
Investigator email 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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4 
CLINICAL INVESTIGATION SUMMARY 
Protocol Title 
Evaluation of safety, usability and subject compliance while using Check- Cap’s C-Scan 
System for providing structural information on colonic polypoid lesions and masses  
Study Number 
 
Sponsor 
Check-Cap, Inc.
Study Design 
Prospective, Multi-center, Single-arm, safety study 
Purpose 
To demonstrate the safety of the Check-Cap C-Scan System 
Study Centers 
Up to two (2) centers located in the United States 
Number of Participants 
45 healthy subjects 
Investigational Device 
Check-Cap’s C-Scan System comprises C-Scan Capsule, C-Scan Track and C-Scan 
View.  
Intended use 
The Check-Cap C-SCAN System is an ingestible capsule system intended to provide 
structural information on the endoluminal surface of the colon for the detection of colon 
polyps. It is intended for use in adults at average-risk for CRC who are not candidates 
for colonoscopy or who decline colonoscopy, or patients who had an incomplete optical 
colonoscopy. 
Primary Objective 
To evaluate the safety of the Check-Cap C-Scan System. 
Secondary Objectives 
• 
To evaluate subject’s compliance 
• 
To evaluate subject’s satisfaction 
• 
To collect data to improve the product’s algorithm 
Primary Safety 
Outcome Measure 
Incidence of device and procedure related Serious Adverse Events (SAE) 
Secondary  
Outcome Measures 
• 
Subject compliance  
• 
Subject satisfaction  
• 
Procedure related data for improvement of algorithm: 
• 
Battery life Assessment 
• 
Device performance 
Inclusion Criteria 
1. Patients age 40 years or older 
2. Able to provide a signed informed consent. 
3. Willing and able to comply with the specified study requirements and follow-up 
evaluations, and can be contacted by telephone. 
4. Able and agrees to undergo colonoscopy procedure. 
5. Body Mass Index (BMI) > 19 and ≤ 35.  
6. Maximum body (abdominal) circumference < 120 cm. 
7. A colonoscopy procedure is pre-scheduled within 60 days 
Exclusion Criteria 
1. Subject who is not a suitable candidate for a colonoscopy (i.e., moderate sedation) 
2. Known history of dysphagia or other swallowing disorders. 
3. History of the followings: Inflammatory Bowel Disease (IBD) including Crohn’s 
disease or Ulcerative, Colitis, Meckel’s Diverticulum, Bowen Hernia, known fistulas 
or strictures (doctors' discretion), or a history of small bowel obstruction. 
4. Known motility disorders:  
a. Chronic Constipation: less than 3 bowel movements/week, w/out the use of 
laxatives. 
b. Delayed gastric emptying. 
c. Narcotic use  
5. Prior history of abdominal surgery that might cause bowel strictures leading to 
capsule retention, as determined by physician discretion with the exception of 
appendectomy, cholecystectomy and hysterectomy 
6. Any condition believed to have an increased risk for capsule retention, strictures, 

 
 
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bowel adhesion or 'obstacles' to free passage of the capsule (such as intestinal 
tumors, radiation enteritis) or incomplete colonoscopies(e.g. due to obstructions or 
non-steroidal anti-inflammatory drugs (NSAID) enteropathy) as determined by 
physician discretion. 
7. Has a cardiac device (e.g. pacemaker or Implantable Cardioinverter Defibrillator 
(ICD)) or any other implanted active device  
8. Known sensitivity to iodine, or with known kidney failure. 
9. Known condition which precludes compliance or is contraindicated with study 
and/or device instructions. 
10. Has a Magnetic Image Resonance (MRI) procedure scheduled within 1 month 
11. Known condition of drug abuse and/or alcoholism.  
12. Women who are either pregnant or nursing at the time of screening (to be verified 
by urine or serum pregnancy test for woman of child- bearing potential who are not 
post-menopausal or undergone surgical sterilization.  
13. Concurrent participation in another clinical trial using any investigational drug or 
device. 
Study Duration 
The total study duration across all patients is expected to be approximately 6 months, 
dependent upon subject recruitment rate. 
Participant Duration 
The duration of study participation for each subject is expected to be approximately 8-
10 weeks. 
 

 
 
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5 
SCHEDULE OF STUDY ASSESSMENTS 
 
Assessments 
Pre-
screening 
Visit 1: 
 
  Baseline 
and C-Scan 
Follow-up 1: C-
Scan  - During 
Procedure 
follow-up 
Follow-Up 2:    
C-Scan 
Procedure End 
follow-up Call 
Follow-up 3: 
Colonoscopy 
Post Procedure 
follow-up Call 
Visit Window 
-30-0 days 
0 days 
0- As required 
days 
1-3 days post 
procedure 
1-3 days post 
procedure 
Questionnaire 
X 
 
 
 
 
Informed Consent 
 
X 
 
 
 
Inclusion/ 
Exclusion Criteria 
 
X 
 
 
 
Demographics 
 
X 
 
 
 
Medical History 
 
X 
 
 
 
Concomitant 
Medications 
 
X 
 
 
 
Pregnancy test1 
 
X 
 
 
 
C-Scan 
procedure 
 
X 
 
 
 
Connect to C-
Scan 
 
X 
 
 
 
C-Scan capsule 
 
X 
 
 
 
Ingest contrast 
 
X 
X 
 
 
FIT test 
 
 
X 
 
 
Follow up phone 
calls2 
 
 
X 
 
 
Capsule 
Excretion 
 
 
 
X 
 
Abdominal x-ray3 
 
 
 
X 
 
Subject 
Satisfaction 
Survey 
 
 
 
X 
X 
Colonoscopy 
Report 
X4 
 
 
 
X 
Follow up visit call 
 
 
 
X 
X 
Adverse Events 
 
X 
X 
X 
 
Study Exit 
 
 
 
 
X 
1Urine pregnancy test for women of childbearing potential 
2Minimum of two phone calls per day until capsule excretion 
3Abdominal x-ray ONLY if suspected that capsule has not been excreted (subject will come to office/unscheduled 
visit) 
4 Collection of a previous colonoscopy report, if available   
 

 
 
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6 
ABBREVIATIONS 
AE 
Adverse Event 
AR 
Adverse Reaction 
BMI 
Body Mass Index 
CFR 
Code of Federal Regulations 
CI 
Chief Investigator 
CIP 
Clinical Investigation Plan 
CMT 
Compton backscattering 
CPS 
Capsule Positioning System 
CRA 
Clinical Research Associate 
CRC 
Colorectal Cancer 
CRF 
Case Report Form 
CRO 
Clinical Research Organization 
CT 
Computerized tomography 
EC 
Ethics Committee (see REC) 
FDA 
Food and Drug Administration 
FIT 
Fecal Immunochemical Test 
FOBT 
Fecal Occult Blood Test 
GCP 
Good Clinical Practice 
GI 
Gastrointestinal 
GLP 
Good Laboratory Practice 
IB 
Investigator Brochure 
IBD 
Inflammatory bowel disease 
ICD 
Implantable Cardioinverter Defibrillator 
ICF 
Informed Consent Form 
ICH 
International Conference of Harmonization 
IFU 
Instructions for Use 
IRB 
Institutional Review Board 
Max 
Maximum 
Min 
Minimum 
MRI 
Magnetic Resonance Imaging 
NAMSA 
North American Scientific Associates 
NSAID 
non-steroidal anti-inflammatory drugs 
PI 
Principle Investigator 
RA 
Radioactive 
RF 
Radio frequency 
SAE 
Serious Adverse Event 
SCA 
Scan Control Algorithm 
StD 
Standard deviation 
SOP 
Standard Operating Procedure 
TMF 
Clinical investigation Master File 
TTT 
Total Transit Time 
UADE 
Unanticipated Adverse Device Effect 
XRF 
X-ray Florescence 
 
 

 
 
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7 
INTRODUCTION 
7.1 
Colorectal Cancer Screening 
Colorectal cancer (CRC) is the third leading cause of cancer death according to the American Cancer 
Society but is largely preventable. Approximately 97,000 new cases of colon cancer will be detected in 
the United States annually, with over 50,000 deaths. Studies published in the early 1990s, showing that 
screening for CRC can reduce CRC -related mortality, led many organizations to recommend screening in 
asymptomatic, average-risk adults older than 50 years. Since then, however, national screening rates 
remain low in most countries.  For example, in the United States for adults age 50 and older, colorectal 
cancer screening was 63% in 2015, Canada 16% (2011), Spain 49.2% (2014) and the Netherlands 
68.2% (2014), including the United States and Europe. Several important studies published over the past 
four years have refined our understanding of existing screening tools and explored novel means of 
screening and prevention 
 
In an attempt to reduce this cancer related death, legislation was passed in both the US and Germany in 
2002, which establishes by law, reimbursement for screening colonoscopy in the population 50 years and 
older in the US, and 55 and older in Germany. This has increased the potential number of screening 
colonoscopies in these 2 countries alone to 15 million colonoscopies a year. 
 
Current strategies to prevent CRC vary considerably with regard to effectiveness, up-front costs, risks, 
and invasiveness.  New CRC screening tests such as Fecal Occult Blood Test (FOBT) and Fecal 
Immunochemical Test (FIT) detect blood in the stool, where fresh or occult is a sensitive indicator for the 
presence of an advanced adenoma or cancerous tumor which are typically bleeding due by angiogenesis 
– a proliferation of blood vessels in the polyp.  FOBT and FIT do not provide structural information of the 
colon and by that fail to diagnose non-cancerous as well as adenomatic polyps They are one mechanism 
to improve adherence. Screening of the colon can be performed by Sigmoidoscopy, endoscopic 
colonoscopy and virtual colonoscopy.  Sigmoidoscopy, endoscopic colonoscopy and virtual colonoscopy 
are invasive and require cleansing of the colon.  Patients are required to conduct a rigorous preparation 
for cleansing of the colon. Stool DNA (ColoGuard) is another recently added test for detecting CRC by 
identifying specific DNA markers which were carried by the Stool from a cancerous tumor in the colon. 
 
The colon preparation process is regarded as one of the main objections of patients, and many choose to 
forgo completion of a scoping procedure as a result. Additionally, for patients with advanced cardiac 
disease, undergoing antithrombotic therapy, considered at high risk to undergo sedation or who have 
kidney diseases which might be compromised by cleansing preparations, scope procedures may pose a 
problem to the patient, Therefore, a technology whereby structural information could be provided, yet 
does not require rigorous cleansing of the colon and is not considered invasive would be beneficial to 
patients.  
 
7.2 
C-Scan Technology 
The technology of the Check-Cap Imaging System is based on a low dose radioactive (RA) sealed source 
embedded in the C-Scan capsule which radiates X-Rays through a collimator to all directions.  The 
capsule is designed to start scanning once it reaches the cecum and the X-ray is emitted when the 
capsule is propagating along the colon during contraction of the walls.  While stationary (which is most of 
the time) the capsule is set at an idle mode and the radiation X-ray source is blocked by the collimator.  
The transit time of the capsule in the colon might vary from 24-100 hours, pending the typical bowel 
activity of the subject. The capsule is powered by onboard batteries and is designed to operate up to 100 
hours.    
 

 
 
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The C-Scan is designed to be ingested without any cleansing of the colon and travel through the 
gastrointestinal (GI) tract naturally while the subject continues daily activities, including eating normally. 
During C-Scan procedure the subject swallows a capsule and capsule travels painlessly through the 
gastrointestinal tract, identifying polyps, the precursors of colorectal cancer.  In order to increase the 
contrast of the colon’s walls and to differentiate them from their content, it is essential to increase the 
stool’s contrast by ingesting radio-opaque material.  It is a standard procedure using approved Iodine 
based liquids, contrast agents such as (Telebrix or Omnipaque) at the discretion of the hospital similar to 
the preparation to abdominal computerized tomography (CT). 
 
During the passage of the capsule in the gastrointestinal tract, it transmits information to a recorder 
attached to the back.  In order to collect data about the instantaneous localization of the capsule traveling 
in the colon additional sensors are embedded in the recorder on the back side. A commercial wrist watch 
is supplied (optional) with the C-Scan system for use by the subject during the procedure. The watch is 
tuned to 'listen' and display the information transmitted from the capsule to the Track.  The watch is a 
monitoring tool to optimize data interpretation during the clinical study and is not an integral part of the C-
Scan system. 
 
After the capsule is expelled, the data from the recorder is downloaded to an acquisition workstation. 
Later, the data is transferred to a processing workstation and analyzed to create a map of the colon. The 
current C-Scan system is designed to operate for up to 100 hours.  The average radiation dose calculated 
from these procedures is 52 uSV (typical results from last study: StD 38, Min. 19, Max. 165 uSV) – this is 
equivalent to one chest X-ray radiation. 
 

 
 
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8 
PREVIOUS STUDIES  
More than 220 volunteers have ingested the C-Scan capsule in its various versions. Three subjects failed 
to ingest the capsule due to Acataposis. All capsules except four were captured and returned by the 
subjects. All returned capsules were tested in Check-Cap laboratories and their sealing and structure 
were verified.  
 
The average transit time estimated from the last 63 procedures (CE study) was ~52 hours with 32h StD. 
In most cases the capsule arrived to the caecum within 24 hours (average 16 hrs.) and the motility 
through the colon was 16 hours (with 32h StD).  
 
Some subjects reported mild diarrhea or mild discomfort, all events resolved within few hours w/out any 
intervention. No capsule retention (more than 300 hours per protocol) had been reported to date. In one 
case the capsule was retrieved by colonoscopy after 100+ hours in the caecum. The 'post' colonoscopy 
was rescheduled earlier according to the request of the participant. Three serious adverse events were 
reported, although, none were device or procedure related. All events were resolved without the need of 
medical intervention.  
 
8.1 
Clinical Study Protocol C-SY 00093 
A multicenter clinical study was conducted at four sites in Israel in 2017. Sixty-Six subjects were enrolled 
(40 Men (61%) and 26 Women (39%), BMI <40), of which three failed to ingest the capsule, including one 
subject with a known swallowing disorder which was not disclosed to the study team during screening.  
Forty-Three had polyp(s) (65%) as indicated by their prior recent colonoscopy reports and the other 23 
were considered as average risk population without any prior information about their colon. 
 
All study procedures were completed and feedback from most subjects was positive and reassuring that 
the procedure was well-tolerated.   
All capsules (except one) were collected and retrieved for QA inspection. They were all found to be intact 
and hermetically sealed.  
 
The total transit time (TTT) is measured in hours between capsule ingestion to excretion.  The TTT is the 
sum of 3 distinct sections:  
a. Time until reaching the caecum 
b. Time capsule dwells in the caecum 
c. Time of colon passage until excretion  
The following table is the summary of all 63 cases in whom the study was completed (3 did not ingest).  
The standard deviation (STD) is quite high due to the considerable variability in bowel motility. 
 
Total Transit Time 
Time to 
Caecum 
Time in Caecum 
Passage in colon 
Average (hours) 
52.3 
15.9 
16.8 
16.5 
STD 
32.9 
13.7 
18.8 
12.1 
 
Table 2: Average transit time of the 3 sections of the GI tract and the standard deviation in each 
one. 
 
There were no cases of C-Scan capsule retention (medical definition of Capsule retention is when TTT is 
longer than 300 hours – about 13 days). 
The C-Scan is designed to operate continuously for 100 hours.   There was one case in which the 
capsule was retained for 100-200 hours and then removed during the follow-up colonoscopy procedure 

 
 
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and in another case it was initiated by the sponsor since the batteries in the capsule were already 
depleted and no additional benefit was expected from the procedure. In two other cases, drugs (Picolax) 
were used to expedite the expulsion of faulty capsules (that stopped working). In all four cases the total 
time was less than 200 hours. In one case the capsule was not retrieved by the patient at the end of the 
procedure and. probably lost in the sewage system.  Abdominal X-ray on the following day confirmed that 
the capsule was expelled with no residual in the GI tract images. All cases were completed uneventfully. 
 
Several adverse events were reported including one case of irritating sensation in the esophagus that 
lingered for hours after capsule ingestion, skin irritation (under the stickers), soft stool, abdominal pain, 
headache, radiation level (body dose) was significantly higher than the typical dose of 50 uSV and four 
cases in which the transit time was longer than 120 hours. Three SAE events occurred including one 
hemorrhage/hematoma seen on abdominal wall, one post-colonoscopy bleeding and one post-
colonoscopy abdominal pain.  All SAE were non-related to device or C-Scan procedure and resolved 
without medical intervention.  Several technical malfunctions occurred during the study, none of which 
resulted in harm to the subject but did not provide any data regarding the performance of the C-Scan 
system.  During the study, updates were made to the system software to continue to optimize the 
algorithm and the ability to collect additional physiological data. 
 
This study demonstrated that the C-Scan procedure was safe as no device- related serious adverse 
event occurred in any C-Scan clinical trial and the procedure was well-tolerated by the participating 
volunteers. The primary end point of safety for the C-Scan system was demonstrated. The primary end 
point for performance in terms of Positive Percent Agreement resulted in 44% capsule vs 37% for FIT. 
The protocol target was set at 55%, hence superiority was demonstrated with a lower than expected 
result. The result of Negative Percent Agreement was 89% vs. a set target of 75%, hence target 
surpassed the expected result.  
 
8.2 
Laboratory Tests 
 
Rigorous laboratory tests have been performed on the Check-Cap Ltd. C-Scan System 
 
8.2.1 Image Reconstruction  
Based on the laboratory tests performed with the current version of our imaging capsule, polyps of 6 mm 
and larger should be visible and 10 mm polyps and larger are expected to be detected at high sensitivity. 
To further enhance the visibility of 6 mm - 9 mm polyps, a new design of the collimator was successfully 
tested in a future version of our imaging capsule, which enables 2.5 times the number of photons to be 
detected on the detectors, allowing the implementation of image enhancement algorithm, which is 
expected to improve the imaging performance. 
 
8.2.2 Polyp Detection 
Laboratory tests were carried out to estimate the capsule’s ability to detect polyps in phantoms 
and demonstrate sensitivity and specificity of such detection ("Polyp Detection Analysis" in the 
Investigator’s Brochure (IB)). Fusion of CMT and XRF data contributed to noise reduction and enabled to 
demonstrate 100% true positive and 0% false positive. 
 
8.2.3 Biocompatibility 
Successful Biocompatibility test performed on Nov/2015 (NAMSA) stated there were no deviations to the 
provisions of the FDA Good Laboratory Practice (GLP) Regulations (21 CFR, Part 58) noted during the 
course of the study. 

 
 
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8.2.4 Animal Studies: 
Raw data from an animal colon ("Animal Testing and Tissue Equivalent Phantom Image Reconstruction" 
in the IB) showing a decrease in X-ray florescence (XRF), photon signals and an increase in Compton 
backscattering, or CMT, signals corresponding to the position of a polyp that was detected when our 
imaging capsule passed over the polyp. 
  
 
 

 
 
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9 
INVESTIGATIONAL DEVICE 
9.1 
Device Description 
The C-Scan technology (Figure 1) is designed to provide structural information of the human colon 
without the need for fasting and prior bowel cleansing, eliminating the need to sedate subject and 
obviating the requirement for the insufflation of colon. 
 
The system modality generates structural information on the colon, and is intended as a preliminary 
assessment of the colon which could assist in the detection of pre-cancerous polyps.   
 
9.1.1 C-Scan System Components  
 
 
Figure 1 : Components of the C-Scan System  

 
 
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• 
C-Scan® Cap: Ingestible capsule (C-Scan Cap) enabling intra-colon feature visualization, based 
on a radioactive source and an array of detectors. 
• 
C-Scan® Track: External Capsule Positioning System (CPS) incorporated into the C-Scan Track 
attached to the subject's back, communicates with the C-Scan Cap, and stores all procedure 
data. 
• 
C-Scan® View: A PC based Workstation (C-Scan View) that enables procedure data loading 
from the C-Scan Track, managing of subject information, 2D and 3D colon imaging, reports 
generation and printouts and storage/reload of procedure data to and from a CD.  An Algorithm 
uses these subsystems to estimate the C-Scan Cap position (using electromagnetic signals 
generated within the C-Scan Cap and the C-Scan Track), identifies C-Scan Cap movements in 
the colon and correspondingly initiates C-Scan Cap scans using a dedicated Scan Control 
Algorithm (SCA) 
 
At the beginning of C-Scan procedure, the subject is connected to the C-Scan Tracker and asked to 
ingest the C-Scan Capsule. In order to increase the contrast of the colon’s walls and to differentiate them 
from their content, it is essential to increase the stool’s contrast by ingesting radio-opaque material.  It is a 
standard procedure using approved Iodine based liquids, contrast agents such as (Telebrix or 
Gastrografine) at the discretion of the hospital similar to the preparation to abdominal CT. After ingestion, 
the subject can go about his or her normal daily routine. The capsule travels painlessly through the 
gastrointestinal tract, seeking polyps. 
 
During the passage of the capsule in the gastrointestinal tract, it transmits information to the C-Scan 
Tracker (recorder) attached to the patient’s back.  In order to collect data about the instantaneous 
localization of the capsule traveling in the colon, sensors are embedded in the recorder. 
 
9.1.2 Radio Frequency (RF) Wrist Watch 
The watch is an optional monitoring tool to optimize data interpretation during the clinical study and is 
not an integral part of the C-Scan system, as in Figure 2.  
Figure 2: RF Wrist Watch  
A commercial wrist watch (product of Texas Instruments) is supplied with the C-Scan system for use by 
the subject during the procedure. The watch incorporates a passive RF receiver which is tuned to 'listen' 
and display the information transmitted from the capsule to the Track.  The added information is 
valuable for the subject to follow the progress of the capsule and to better understand messages from 
the system. 
 
. 
  

 
 
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10 STUDY OBJECTIVES 
10.1 Primary Objectives 
To evaluate the safety of the Check-Cap C-Scan System. 
10.2 Secondary Objectives  
• 
To evaluate subject’s compliance 
• 
To evaluate subject’s satisfaction 
• 
To collect data to improve the product’s algorithm 
10.3 Primary Safety Outcome Measure 
The safety of the Check-Cap System will be evaluated by the incidence of device or procedure related 
Serious Adverse Events (SAE), as adjudicated by the Independent Physician Adjudicator.  
10.4 Secondary Outcome Measures  
• 
Subject compliance will be assessed by 
-  Non-compliance rate throughout the study via diary completion by the subject  
Specific questionnaire. completed by remote subject monitoring (via telephone)  
 
• 
Subject satisfaction will be established by: 
‐ 
Designated questionnaire that focuses on patient’s impressions regarding tolerance and potential 
safety concerns. Acceptance criteria was defined as average score >3.5 (1- low satisfaction to 5- high 
satisfaction), which represent high satisfaction with the safety and tolerance of the C-scan system. 
‐ 
Comparing patient’s satisfaction with colonoscopy procedure. 
 
• 
Collecting procedure related data: 
‐ 
Technical performance in normal daily routine. 
‐ 
Segmental transit time. 
‐ 
Procedure duration. 
‐ 
Bowel movements. 
‐ 
Agreement between C-Scan and colonoscopy with respect to the presence/absence of colonic 
polyp(s) [Note: C-scan data not to be used for clinical decision making in the care of patients, for 
this clinical study]. 
‐ 
Inter-observer variability in the detection of significant clinical findings on a 'per patient' decision 
• 
Battery life Assessment 
‐ 
Assessing adequate power supply for complete scan of the colon: length of capsule operation 
lifetime with respect to the lifetime specification of 100 +/- 10% hours. 
• 
Device performance 
‐ 
Assessing colon model by the physician reviewers as presented on C-Scan View (e.g., normal, 
partial, right side missing, etc.). 
‐ 
Collecting data to improve the product’s algorithm. 

 
 
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11 STUDY DESIGN 
11.1 Overall Design 
Up to 45 healthy subjects will participate in this study. Subjects to be enrolled in this study are indicated 
and scheduled to undergo optical colonoscopy based on the following symptoms or by being classified as 
higher than average risk based on one or more of the following: 
• 
Surveillance - Significant findings in previous optical colonoscopy 
• 
Diagnostic - Polyps detected in virtual colonoscopy referred for polypectomy 
• 
Diagnostic - Polyps detected in previous optical colonoscopy (community setting) referred for 
polypectomy 
• 
Diagnostic - Positive FIT test 
• 
Diagnostic – one or more of the typical symptoms:  
• 
abdominal pain 
• 
Change in bowel habits 
• 
Anemia or overt bleeding in stool 
• 
Significant weight loss 
• 
First degree relatives of CRC subjects  
Alternatively, average risk based on their age and demographics referred for screening for polyps 
 
Each subject will receive a comprehensive explanation regarding the study nature.  During this process, 
and per ethical committee approval, subjects may be asked several questions (over the phone) regarding 
their medical background for preliminary assessment of eligibility. Once informed consent is obtained, a 
thorough evaluation of subject’s eligibility will be performed based on inclusion / exclusion criteria.  
Eligible subjects will be required to undergo FIT procedure, per package insert instructions, within pre-
defined timelines. All subjects will be scheduled to undergo capsule procedure, to be followed later on 
with optical colonoscopy procedure. 
 
One to three days following end of C-Scan procedure the subjects will be contacted by phone by the 
clinical coordinator to follow-up on the subject well-being. Same follow-up procedures will be applied one 
to three days following Optical Colonoscopy procedure. Medical history and concomitant medication 
information will be collected for all subjects. 
 
11.2 Study Duration 
The duration of study participation for each subject is expected to be approximately 8-10 weeks. The total 
study duration across all patients is expected to be approximately 6 months, dependent upon subject 
recruitment rate. 

 
 
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12 SUBJECTS ELIGIBILITY 
12.1 Study Population 
The total Study population is up to 45 subjects at up to two investigational sites in the United States.  
 
12.2 Inclusion Criteria 
a. Male or female at the age of 40-80 years' old. 
b. Subject provided signed informed consent. 
c. Subject is willing and able to comply with the specified study requirements and follow-up 
evaluations, and can be contacted by telephone. 
d. Subjects able and agrees to undergo colonoscopy procedure. 
e. BMI ≥ 19 and ≤ 35.  
f. 
     Maximum body (abdominal) circumference < 120 cm. 
g. Has at least 3 bowel movements per week 
h.  A colonoscopy procedure is pre-scheduled within 60 days  
12.3 Exclusion Criteria 
a. Subject who is not a suitable candidate for a colonoscopy (i.e., moderate sedation) 
b. Known history of dysphagia or other swallowing disorders. 
c. History of the followings: Inflammatory Bowel Disease (IBD) including Crohn’s disease or 
Ulcerative, Colitis, Meckel’s Diverticulum, Bowen Hernia, known fistulas or strictures (doctors' 
discretion), or a history of small bowel obstruction. 
d. Known motility disorders:  
i. Chronic Constipation: less than 3 bowel movements/week, w/out the use of 
laxatives. 
ii. Delayed gastric emptying. 
iii. Narcotic use  
e. Prior history of abdominal surgery that might cause bowel strictures leading to capsule 
retention, as determined by physician discretion with the exception of appendectomy, 
cholecystectomy and hysterectomy 
f. 
Any condition believed to have an increased risk for capsule retention, strictures, bowel 
adhesion or other obstacles to free passage of the capsule (such as intestinal tumors, radiation 
enteritis) or incomplete colonoscopies (e.g. due to obstructions or NSAID enteropathy) as 
determined by physician discretion. 
g. Has a cardiac device (e.g. pacemaker or ICD) or any other active implanted device 
h. Known sensitivity to iodine, or with known kidney failure. 
i. 
Known condition which precludes compliance or is contraindicated with study and/or device 
instructions. 
j. 
Has a Magnetic Image Resonance (MRI) procedure scheduled within 1 month 
k. Known condition of drug abuse and/or alcoholism.  
l. 
Women who are either pregnant or nursing at the time of screening (to be verified by urine or 
serum pregnancy test for woman of child- bearing potential who are not post-menopausal or 
undergone surgical sterilization.  
m. Concurrent participation in another clinical trial using any investigational drug or device. 
 
 

 
 
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12.4 Withdrawal Criteria 
Subjects may withdraw from the study at their own request at any time.  
The investigator may withdraw a subject from the study at any time for the following reasons: 
a. Severe side effects clearly related to the study device or procedure 
b. Less than adequate compliance with the study routine 
c. Presence or appearance of exclusion criteria 
d. Refusal to undergo 'post' colonoscopy  
e. A significant protocol violation 
f. 
At the specific reasonable request of the sponsor 
The sponsor must be informed in each withdrawal case within 24 hours. The reason for withdrawal has to 
be recorded in the subject’s file. 

 
 
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13 STUDY PROCEDURES AND SCHEDULE 
13.1 Study Procedures 
The C-Scan study procedures and flow are outlined in Figure 3.  The schedule of study assessments are 
listed in Table 1.  The subjects are only required to attend two visits, but are expected to conduct phone 
assessments after ingestion but prior to expulsion of the capsule.   
 
Table 1: Schedule of Assessments 
Assessments 
Pre-screening 
Visit 1:  
Baseline and 
C-Scan 
Follow-up 1: 
C-Scan  - 
During 
Procedure 
follow-up 
Follow-Up 2: 
C-Scan 
Procedure 
End 
follow-up Call 
Follow-up 3: 
Colonoscopy 
Post 
Procedure 
follow-up Call 
Visit Window 
-30-0 days 
0 days 
0- As required 
days 
1-3 days post 
procedure 
1-3 days post 
procedure 
Questionnaire 
X 
 
 
 
 
Informed Consent 
 
X 
 
 
 
Inclusion/ Exclusion 
Criteria 
 
X 
 
 
 
Demographics 
 
X 
 
 
 
Medical History 
 
X 
 
 
 
Concomitant 
Medications 
 
X 
 
 
 
Pregnancy test1 
 
X 
 
 
 
C-Scan procedure 
 
X 
 
 
 
Connect to C-Scan 
 
X 
 
 
 
C-Scan capsule 
 
X 
 
 
 
Ingest contrast 
 
X 
X 
 
 
FIT test 
 
 
X 
 
 
Follow up phone 
calls2 
 
 
X 
 
 
Capsule Excretion 
 
 
 
X 
 
Abdominal x-ray3 
 
 
 
X 
 
Subject Satisfaction 
Survey 
 
 
 
X 
X 
Boston Bowel 
Preparation Scale 
(BBPS) 
 
 
 
 
X 
Colonoscopy Report 
X4 
 
 
 
X 
Follow up visit call 
 
 
 
X 
X 
Adverse Events 
 
X 
X 
X 
 
Study Exit 
 
 
 
 
X 
1Urine pregnancy test for women of childbearing potential 
2Minimum of two phone calls per day until capsule excretion 
3Abdominal x-ray ONLY if suspected that capsule has not been excreted (subject will come to office/unscheduled 
visit) 
4Collection of a previous colonoscopy report, if available 
 
 

 
 
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Prescreening  
Eligible:  Schedule in 
person visit 
Not Eligible:  Document 
as screen failure 
Visit 1:  Informed Consent, 
Baseline, C-Scan Ingestion and 
Activation, Adverse Events 
Follow-Up 1: Remote Follow-Up 
(2x/day during C-Scan use):  
Questionnaires, Adverse Events; 
FIT Test, Ingest contrast 
Follow Up 2: Remote Follow-Up 
Call/Capsule Excreted?
Naturally:  Return via 
shipping container  
Did not excrete after X hours: 
Unscheduled In-person visit 
with abdominal x-ray 
Follow-up 3: Remote Follow-Up 
Call:   
Post-Colonoscopy Questionnaire 
Study Completion Form 
Colonoscopy Report 

 
 
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Figure 3: Study Procedure Flow Chart 
13.2 Study Documentation 
The following documents and information will be collected: 
• 
Completed Visit and Follow-up Case Report Forms (CRFs) 
• 
Referring procedure report (optical colonoscopy or virtual colonoscopy), if applicable 
• 
FIT Results (+ photo)  
• 
Subject's diary with all daily activities during home procedure 
• 
Subject's usability questionnaire 
• 
Subject Satisfaction Questionnaire 
• 
C-Scan procedure raw data 
• 
C-Scan report 
• 
Optical Colonoscopy report 
• 
Video recording of Optical Colonoscopy 
• 
Pictures of Optical Colonoscopy, if taken 
• 
Copy of pathology report, if conducted 
13.3 Prescreening 
Potential eligible patients scheduling an optical colonoscopy may be approached regarding participation 
in this study.  Patients will be prescreened may be completed in person or via phone and logged on the 
Prescreening Log with outcomes regarding potential eligibility.    
13.4 Informed Consent Process 
An explanation of the study device, the study and participation requirements will be provided to each 
eligible prescreened patient. The informed consent document will be reviewed with each patient and they 
will be provided time to ask questions. Consent to participate in this study must be given in writing. The 
signed informed consent will remain in subject’s file. A signed copy will be given to the subject. 
 
Informed consent will be obtained prior to any study procedures being conducted.  Site will maintain a log 
with all subjects who signed an informed consent to participate in the trial. The log will include the 
subject’s full name, subject’s study code and date of enrollment. Enrollment log will be kept in the site’s 
Regulatory Binder which is maintained in a secure location. The subject is considered enrolled at the 
completion of the informed consent process 
13.5 Visit 1: Baseline  
Upon completion of the informed consent process, subject’s eligibility will be assessed against the 
Inclusion and Exclusion criteria. Previous reports of optical or virtual colonoscopy should be collected and 
kept with the subject’s file. 
 
If the subject does not meet the inclusion/exclusion criteria, they will be considered a screen failure and 
excluded from the analysis.    
 
The following information will be collected at this visit: 
• 
General medical history and concomitant medication will also be assessed and documented.  
• 
Subject’s demographic and baseline information will be assessed and documented, including: 
date of birth, gender, height, weight, belly circumference, prior abdominal surgery, GI symptoms, 
and reason for referral.  
• 
If applicable, documentation of previous GI procedures, such as optical colonoscopy   
 

 
 
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13.5.1 C-Scan Procedure 
Subjects will be instructed to skip breakfast or lunch on the day of C-Scan Capsule ingestion to expedite 
gastric passage. Liquids are allowed.   
 
The subjects will be connected to the C-Scan Track and after successful system's activation (BIT – built in 
test), the subject will be asked to ingest the C-Scan Capsule with some water, contrast media (GE 
Omnipaque 350) and non-soluble fiber, in the presence of a physician investigator or designee.  The 
subject will also be provided with an RF watch.  A representative of the sponsor will attend the ingestion 
procedure, as needed to assure proper activation. 
 
Post ingestion, the subject will receive detailed instructions about the daily routine and activities as well 
as use of the RF watch and then will be discharged home with written instructions on the procedure 
Instructions for use (IFU), daily diary, FIT kit and capsule return kit.  
 
13.6 Follow-Up 1 
13.6.1 FIT Procedure 
All subjects will be required to perform FIT procedure using [OC-Light] FIT Kit prior or during the capsule 
procedure.  
 
The subjects can perform the test at their home, per their convenience, as per package insert 
instructions, and report the results to study team (photo of the strip with 1-2 lines). Additional guidance 
will be provided by the site clinical team as required. Alternatively, FIT procedure may be conducted at 
the clinic, on the day of C-Scan Capsule ingestion. In case of unclear results, the FIT test will be 
repeated. One positive result in any of the tests will be considered as positive. FIT procedure date and 
results will be recorded and documented. 
 
13.6.2 Capsule Progress Days: Contrast Ingestion, Laxatives and Non-Soluble 
Fiber  
One the days in which the capsule is progressing within the subject, the subject is required to ingest 
contrast media (GE Omnipaque 350, FDA approved under NDA 018956) as well as non-soluble fiber 
supplements.  The subject will be required to ingest daily dose (3 X 15 ml) of contrast media, to be 
consumed three times per day as well a non-soluble fiber 3x/day with normal diet.  
The subject will be provided with Laxadin (5 mg tablets) to be ingested according to the doctor 
recommendation, on an as needed basis.  In routine procedures, subjects might be instructed to take 2 X 
5 mg tablets 48-72 hours after ingestions (unless the capsule was already excreted).  
 
13.6.3 Subject Diary 
All subjects will be required to keep a log ('Subject's Diary') during procedure documenting general 
activities, contrast media intake, fibers intake, and food consumption, bowel movement, and system 
visual/auditory indicators. 
 
13.6.4 Follow-Up Phone Calls 
During capsule procedure/progress days, the subjects will be contacted by phone several times daily by 
the site clinical study team or by dedicated external trained personnel to assess the subjects well-being 
and to monitor for any change or discomfort, subject satisfaction adverse events and procedure progress.  
 
During the call, if a complaint related to the technical functioning of the device is received, subjects may 
be also monitored by the technical team (either at home or at the clinic), who may need to examine the 

 
 
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system or inquire the subjects about the system visual/auditory indicators in order to assure optimal 
operation of the C-Scan system.  If an adverse vent is reported, the caller will notify the site study team 
and determine the appropriate course of action.  
 
13.7 Follow Up 2: Capsule excretion and collection 
13.7.1 Capsule Return 
Capsule procedure is completed upon capsule excretion or system auditory indication of ‘End of 
Procedure’. Subjects will be instructed to inform the study coordinator or designee upon capsule 
excretion.    
 
The subjects will be provided with a dedicated capsule collection kit, to assist the subjects in collecting 
the capsule. Subjects will be instructed to retrieve the capsule upon excretion.  Return packaging and 
instructions will be provided. The subject will return with the Kit the diary, the questionnaire and all 
unused materials. 
 
In case of doubt regarding capsule excretion, and per physician discretion, subjects may be referred to 
abdominal X-Ray to confirm capsule excretion. 
 
13.7.2 Usability Questionnaire 
Usability questionnaire will be provided with each Kit and the subjects are instructed to answer these 
questions once the procedure is completed. A question regarding whether the subject has experienced 
any adverse events will be included.   
 
13.8 Follow-Up 3: Post-Colonoscopy Procedure  
Subject will be telephoned by study site to assess subject satisfaction with the colonoscopy procedure as 
compared to the C-Scan.  Follow up window is 1-3 days post-colonoscopy.    Additionally, the BBPS and 
colonoscopy report will be collected from the test site for comparative analysis with the C-Scan 
procedure.   The subject will be exited from the study upon completion of this follow-up 
 
13.9 Unscheduled Visit(s) 
After 100 hours following Capsule ingestion, if the subject is unaware of the excretion of the capsule, or if 
it suspected that the capsule has not been excreted naturally, the subject will call the site to determine 
options for excretion.  They may be asked to return to the investigative site for an abdominal x-ray to see 
if the capsule remains in the body. If so, measures will be taken by site personnel to ensure capsule 
excretion. See Capsule Retention section below. 
 
13.10 C-Scan Analysis  
Upon return of the capsule to the investigational site, the capsule data will be downloaded from the 
“Track” and validated for completeness by the technical team. Next, the raw data will be transformed to 
3D format ('reconstruction') by the View workstation and optionally, selected bookmarks will be prepared 
for the Viewers.    
 
The files will be transferred to designated centralized reading center (may be located outside the United 
States) and reviewed by three trained medical reviewers for clinical analysis and preparation of procedure 
subject report.   Each reviewer will generate a final report including 'per patient' recommendations. 

 
 
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Decision on presence/absence of polyps will be determined by majority. 
 
C-Scan findings will be compared to the FIT results and to the study Optical Colonoscopy procedure.  
 
 

 
 
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14 STATISTICAL ANALYSIS  
 
14.1.1 Sample Size Considerations 
This is a pilot safety study; therefore, sample size is not determined by power analysis. 
Up to 45 subjects will be recruited to the study.  
 
14.1.2 Primary Analysis Set 
The primary objective of the study is to establish the safety of the Check-Cap C-Scan system. 
The primary analysis set for establishing the safety of the Check-Cap C-Scan system will include all 
subjects who underwent C-Scan procedure per protocol.  
 
14.1.3 Operational Analysis Set 
Technical or operational failures that will be discarded from the trial statistical analysis will include all 
cases where the system did not function as expected: 
• 
Capsule operational failure. 
• 
Track operational failure.  
• 
Subject's noncompliance with procedure requirements 
 
14.1.4 Data analysis 
Descriptive statistics for all parameters will be calculated. For continuous parameters descriptive statistics 
including mean, standard error, median, minimum, and maximum values will be reported overall and at 
each time-point. For ordinal parameters, counts and percentages may be reported in addition to the 
mean, standard error, median, minimum, and maximum values. Categorical parameters will have counts 
and percentages reported overall and at each time-point. 
 
14.1.5 Interim Review of Data 
An interim report may be generated depending on rate of enrollment and completeness of study data 
generated from patients enrolled. It is anticipated that enrollment will be conducted quickly and the 
potential timing for an interim analysis may not be feasible.   
 

 
 
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15 SAFETY CONSIDERATIONS 
15.1 Safety Parameters  
15.1.1 Risks Associated with Participation In The Clinical Investigation  
The risks associated with the C-Scan system are similar to those risks associated with regular Capsule 
Endoscopy.   Risks associated with both Capsule Endoscopy and the Colon Capsule include but not 
limited to the following: constipation or diarrhea, capsule delay or retention throughout the GI tract, 
erosion of the colon mucosa, allergic reaction to the ingested contrast material, pain and discomfort.  
15.1.2 Potential Risk From The Capsule Procedure 
• 
Delayed excretion or retention of the capsule in the GI tract 
• 
Exposure to low dose X-ray radiation during the capsule passage and from the 
abdominal X-ray (if required, post questionable excretion) 
• 
Exposure to low level electromagnetic radiation  
• 
Change in bowel habits or abdominal discomfort during the passage of the capsule 
• 
Unexpected capsule related Adverse Events  
 
15.1.3 Capsule Retention 
There is a low risk of capsule retention, i.e., no excretion of the capsule after more than 300 hours 
(defined as SAE).  Delayed capsule excretion is defined as no excretion of the capsule after 100 hours 
(approximately 4 days).  In some instances, intervention is required to remove the capsule.  Intervention, 
based on the physician’s decision and imaging of the capsules location may include:  use of laxatives, 
non-soluble fiber supplements, removal by colonoscopy or surgery. 
 
15.1.3.1 Possible Scenarios and Recommended Physician's Action: 
In all cases the physician may opt to use local protocols for patients administered with gastrointestinal 
capsules; medical intervention or lack of, which remains at physician’s discretion. 
• 
Capsule is Not Found After C-Scan® Track indicates it was expelled 
‐ 
Advise the subject to look in the toilet. If it is found, the subject should notify the 
clinic which will arrange for the collection of the C-Scan system. 
‐ 
If the capsule is not found, the subject should speak with a physician at the clinic 
as there is a chance it was not expelled despite the positive indication. The 
physician might recommend using a laxative at home to try to expel the capsule. 
Make sure that the subject knows to use the collection kit during any bowel 
movements. Or, the physician investigator may recommend the subject to 
come to the clinic for a physical exam, and depending on findings, consider 
abdominal X-Ray imaging. 
• 
Capsule Not Expelled After 4 Days (~100 hours) 
‐ 
If 4 days have passed and the capsule was not expelled, the subject should 
speak with a physician at the clinic (if needed, be sure to initiate a contact with 
the patient). The physician might recommend using a laxative at home to try to 
expel the capsule. Make sure that the subject knows to use the collection kit 
during any bowel movements. Or, the physician investigator may recommend 
the subject to come to the clinic for a physical exam, and depending on 

 
 
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findings, consider abdominal X-Ray imaging. 
‐ 
Intervention, based on the physician's decision and imaging of the capsule's 
location, may include: use of laxatives, fibers, removal by colonoscopy, or by 
surgery. 
‐ 
In case that the capsule is retained in the small bowel, as suspected according 
to the X-Ray imaging, the recommended Intervention, based on the physician's 
decision, may include: use of laxatives, prokinetic drugs, removal by SB 
enteroscopy (with double balloon if available) or by surgery. 
• 
Capsule lost communication (no flashing lights on Track) at any time between 
ingestion and 100 hours: 
‐ 
Advise the subject to verify that the batteries in the Track are in position and the 
compartment is well secured 
‐ 
Verify that the patient is still wearing the Track on his/her back 
‐ 
If communication is still interrupted or missing, contact the technical support 
to consult about potential malfunctions and interventions. 
‐ 
If the problem is not resolved and the communication is missing - have the 
patient come to the clinic   
‐ 
There is no reason to assume there is a safety malfunction, but since the 
procedure is not yielding any additional valuable clinical data, it is recommended 
to take steps to expel the capsule out. 
‐ 
The clinic team (technician and/or physician) should perform, in case the 
capsule has not been excreted and collected already, abdominal X-Ray to 
assure the capsule location within the GI tract. 
‐ 
Intervention, based on the physician's decision and imaging of the capsule's 
location, may include: use of laxatives, fibers, removal by colonoscopy, or by 
surgery. 
• 
Technical Malfunction – C-Scan® Track Sent a Fault Indication 
‐ 
Verify that the auditory indication was from the C-Scan® Track and not a 
background noise. A C-Scan® Track safety fault indication is identified by a 
series of repeated beeps.  
‐ 
Ask the subject if a single indication was received, or was it repeated at regular 
intervals.  
‐ 
Ask if the subject feels any discomfort. 
‐ 
If it is a Safety malfunction (risk of higher than usual body radiation exposure), 
have the subject come to the clinic ASAP and no later than 48 hours post call. 
‐ 
If the capsule has not already been excreted and collected, the clinic team 
(technician and/or physician) should perform abdominal X-Ray to assure the 
capsule location within the GI tract.  
‐ 
In the case of Safety Malfunction, intervention is required to remove the capsule 
without delay (recommended within 24 hours). Intervention, based on the 
physician's decision and imaging of the capsule's location, may include: use of 
laxatives, fiber supplements, removal by colonoscopy, or by surgery.   

 
 
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‐ 
Efforts should be made to minimize the subject's exposure by removing the 
capsule out of the body. 
15.1.4 Low X-Ray Body dose 
In addition, the capsule emits low level X-Ray radiation for a few seconds each time it scans the colon. 
The major source of radiation dose is from Ta182, a byproduct contaminant. 
 
The radiation may potentially cause damage to the colon or nearby organs.  Based on calculations the 
radiation dose level is rather low: 100 times lower than CT Colonography or similar to the radiation your 
body absorbs while flying from Europe to New York (8 hour flight = 0.06 mSv).  
 
Once the capsule is excreted, the risk of radiation is eliminated.  

 
 
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16 ADVERSE EVENTS 
Subjects will be carefully monitored for adverse events. Subjects will be guided to report if they feel any 
pain or discomfort during the trial. At each visit or phone contact, subjects will be asked if they 
experienced any adverse reaction since the last visit. 
 
Any adverse events with an onset following beginning of bowel preparation to colonoscopy procedure will 
not be collected. Colonoscopy related adverse events are not part of the study, are considered standard 
of care and will not be reported.   
16.1 Adverse Event Definitions 
16.1.1 Adverse Event 
An Adverse Event is any unwanted medical occurrence in a subject (e.g. sign, symptom, illness, 
abnormal laboratory value, or other medical event) occurring to a subject that appears or worsens during 
a clinical study, whether or not considered related to the device. 
 
16.1.2 Serious Adverse Event 
An SAE is any adverse event that: 
• 
Led to death 
• 
Led to a serious deterioration in the health of the subject 
• 
Resulted in permanent impairment of a body structure or body function. Required in subject 
hospitalization or prolongation of existing hospitalization 
• 
Resulted in medical or surgical intervention to prevent life threatening illness or permanent 
impairment to body structure or body function 
• 
Led to fetal distress, fetal death, or congenital anomaly/birth defect 
 
16.1.3 Unanticipated Adverse Device Effect (UADE) 
An unanticipated adverse event is any serious, device related adverse event, if that event was not 
previously identified in the risk analysis and consent form in 
• 
Nature 
• 
Severity or frequency 
• 
Unreasonable risk is not defined. It shall be determined by the management on a case-by-case 
basis through evaluation of serious and unanticipated adverse events 
 
16.1.4 Device Malfunction/Failure 
Malfunction means the failure for device to meet its performance specifications or otherwise perform as 
intended. In general, this is related to a component of the system not functioning as intended to provide 
the required outputs. Examples of a device malfunction include: 
• 
C-Scan capsule does not traverse through the colon – the scanning of the colon is aborted prior 
to reaching the rectum or the image scan density throughout the colon is inadequate for clinical 
interpretation 
• 
C-Scan shield does not retract – temporarily excessive radiation from the capsule  
• 
C-Scan does not record tracking through colon- temporarily or continuous loss of tracking of the 
capsule by the recorder, causing inadequate or partial activation of the scanning function 
• 
Corrupted data – the stored data in the recorder is corrupted and cannot be interpreted by the 
C=Scan View for clinical data analysis  
• 
External interference – External electromagnetic interference (Hybrid cars, generators or other 
sources) cause interference to the communication with the capsule or to the tracking circuitry, 
thus causing periods of lost data during the procedure 

 
 
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• 
Physiological causes – subjects who fail to ingest the capsule, or subjects in which the capsule 
dwells in the caecum for a period of ~100 h or more, thus exceeding the operation time of the C-
Scan system  
 
16.2 Anticipated Adverse Events  
The following events are known potential adverse events from the C-Scan procedure.  They will be 
reported as adverse events for the purposes of the study: 
• 
Delayed C-Scan Capsule excretion  
• 
Capsule retention  
• 
Change in bowel habits 
• 
A small amount of fresh blood in the stool  
• 
Potential difficulty swallowing the capsule 
• 
Abdominal discomfort during the passage of the capsule 
• 
Abdominal pain, cramps 
• 
Back pain 
• 
Nausea 
• 
Loss of appetite 
• 
Soft/runny stool 
• 
More than 2/day bowel movements 
• 
Diarrhea 
• 
Constipation  
• 
Allergic reaction to the ingested contrast material 
• 
Skin irritation caused by the stickers on back 
• 
Impaired night sleep caused by the C-Scan track (recorder on the back)  
• 
Excessive radiation exposure (> 200 [ uSv] microSivert) Note: This threshold was calculated as 
2X the max body dose in a long, but normal, procedure: total transit time of 100 hours and with 
4000 scanning pages, which is the maximum ever reached during a normal procedure. 
 
16.3 Recording and Documentation of Adverse Events 
All adverse events should be evaluated by the Investigator, and should be medically handled per 
investigator discretion. All adverse events shall be recorded in the subject’s Adverse Event Case Report 
Form. The following data should be carefully documented: 
• 
Subject’s study ID/code 
• 
Type of event 
• 
Time of occurrence (i.e. date & time) 
• 
Time of resolution (i.e. date & time) 
• 
Severity degree (mild/moderate/severe/unknown) 
• 
Relationship to study device (definitely/probably/possibly/probably-not/not-related) 
• 
Measures taken (e.g. concomitant medication, hospitalization, etc.) 
• 
Event outcome (unchanged/worsened/improved/resolved/unknown/death) 
 
Adverse events will be assessed in terms of seriousness, duration, intensity and relationship to the study 
device and/or procedure. All anticipated and unanticipated adverse events will be collected and reported.  
 

 
 
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16.3.1 Severity 
The outcome of each adverse event will be observed and documented. Adverse events will be graded as 
follows: 
• 
Mild: Sign or symptom, usually transient, requiring no special treatment and generally not 
interfering with usual activities. 
• 
Moderate: Sign or symptom, which may be improve by simple therapeutic measures, may 
interfere with usual activities. 
• 
Severe: Sign or symptom that is intense or debilitating and that interferes with usual activities. 
Recovery is usually aided by therapeutic measures and the discontinuation of the study device 
may be required. 
 
16.3.2 Relationship 
The relationship of the adverse event to the study is defined as follows: 
• 
Definitely: An adverse event was shown to be related to the study device. 
• 
Probably: An adverse event has a strong temporal relationship to study device, and another 
etiology is unlikely or significantly less likely. 
• 
Possibly: An adverse event has a strong temporal relationship to the study device, and an 
alternative etiology is equally or less likely compared to the potential relationship to the study. 
• 
Probably not: An adverse event has little or no temporal relationship to the study device and/or a 
more likely alternative etiology exists. 
• 
Unrelated: An adverse event has no temporal relationship to study device or has a much more 
likely alternative etiology. 
16.4 Safety Reporting Procedures 
16.4.1 Adverse Events Reporting 
Subjects are encouraged to report any event to the study team and consult the PI for any change in their 
well-being. Subjects will be asked for any change in their medical condition during each study visit or 
phone call with the exception of Visit 2 for the standard of care Colonoscopy and the associated 
preparation procedure.   
 
16.4.2 Serious Adverse Events Reporting 
Serious adverse events shall be reported to Check-Cap/Clinical Research Organization (CRO) in writing 
(using the Serious Adverse Events Form taken from the CRF) within 24 hours of the investigator’s 
awareness of the event, and should be reported to the local Ethical Committee per their requirements. 
 
16.4.3 Unanticipated Adverse Device Effect Reporting 
Unanticipated adverse device effects shall be reported to Check-Cap/CRO in writing (using the Serious 
Adverse Events Form taken from the CRF) within 24 hours of the investigator’s awareness of the event.  
 
Check-Cap/CRO will request additional information if needed and Check-Cap will report the event to the 
FDA within 10 working days of first notification of the event.  The Investigator must notify their IRB of the 
event no later than 10 working days after learning of the vent.   
 

 
 
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17 DATA COLLECTION AND QUALITY CONTROL 
17.1 Data Collection 
Each investigative site will complete CRFs during the study. Each subject participating in the study must 
have all applicable CRFs accurately and diligently completed. It is the investigator responsibility to ensure 
by signature the completeness and accuracy of the CRFs. 
 
Procedures report (e.g. optical colonoscopy report) and forms completed by the subjects (e.g. Diary) will 
be considered as source documents and provided to the sponsor de-identified. Copies of the CRFs may 
also be print out and used as source documents per site team convenience, as long as these are marked 
as source documents.  
 
CRFs and any other study documents will not include any identifying details of the subjects, and all 
identifying details will be decoded to include study specific numeric code and subject initials.  
 
Completed CRFs shall be monitored and verified against source documents, and signed by the 
investigator as a confirmation of accuracy and adequacy. 
17.2 Data Monitoring 
Monitoring will be conducted by the sponsor or designees per the study monitoring plan. Informed 
Consent Forms will be monitored for 100% adequacy and accuracy and study data will be monitored via a 
risk based approach outlined in the monitoring plan. 
17.3 Data Archiving  
All study documentation will be kept for a period of 2 years from study completion or termination, or the 
date which the records are no longer needed to support a premarket approval or De Novo classification 
application.  Prior to discarding records, the investigative site should contact Check-Cap to receive 
clearance for proceeding or obtain alternative instructions 

 
 
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18 LABELING 
All equipment associated with the clinical study will be identified with visible markings stating:  
“CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use”  

 
 
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19 DELIVERY, STORAGE AND DISPOSITION 
The C-Scan capsule and accessory kit will be shipped to the investigative site in advance of the 
procedure.  Based upon the cadence of scheduled procedures, the site may be provided several units at 
a time to have inventory on hand.  
 
All device and accessories must be tracked within the device accountability log and stored in a secure 
location available to only authorized study personnel.  C-Scan should be kept in a dry location at room 
temperature.   
 
At the end of the C-Scan procedure, a representative of the sponsor will collect the Kit, document and all 
unused material directly from the subject. C-Scan units returned from the subject will be shipped back to 
the sponsor. 

 
 
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20 ETHICAL AND LEGAL ASPECTS 
20.1 Ethical Committee Review and Approval 
Study protocol and applicable documents must be submitted to the Ethics Committee/IRB for approval 
prior to study commence. Documented approval will be obtained for all participating sites. When needed, 
study extension, amendment or renewal of the Ethical Committee approval must be obtained. 
20.2 Ethical Conduct of the Study 
The procedures set for the in this study protocol are designed to ensure adherence with Good Clinical 
Practices. This study must also comply with the local regulatory requirements. 
 
Both the Investigator and the Sponsor are required to maintain study records, including regulatory 
approvals, as required by the applicable regulatory requirements. 
 
The investigator must agree to the inspection of study related records by a regulatory authority or Check-
Cap representatives and must allow direct access to source documents and any other study related 
documents. 
20.3 Subject Information and Consent 
Prior to the beginning of the trial, the investigator is responsible to obtain the Institutional Review Board 
approval of the written informed consent and any other written information provided to the subjects. 
Institutional Review Board approvals must be filed in the study records. 
 
The process of obtaining informed consent must be in accordance with IRB approval, Good Clinical 
Practice, and local regulatory requirements. Written informed consent must be obtained prior to any study 
specific procedure. 
20.4 Confidentiality 
All subjects identifying records will be kept confidential. Subjects names will be kept confidential and all 
study records will include only subject study code and initials. If any identifying details (e.g. name, 
address, etc.) appears on any study related document, it must be redacted. 
 
The subjects will be informed in writing (i.e. Informed consent), that representatives of the sponsor, CRO, 
Institutional Review Board or other 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 
strict confidence and in accordance with local laws. Subjects will be informed in writing that any future 
publication will not include identifying information. 
20.5 Insurance 
The sponsor is responsible to provide insurance coverage for the clinical trial.   

 
 
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21 DISCLOSURE AND PUBLICATION OF INFORMATION 
All proprietary information including; Check-Cap Ltd’s operations, patent application, formulas, 
manufacturing processes, basic scientific data, and formulation information provided to the investigator or 
the methodologies used in this study, as well as proprietary information obtained during the course of the 
study are confidential and will remain the sole property of Check-Cap Ltd.  
 
The investigator agrees not to disclose any proprietary information supplied by Check-Cap Ltd. in any 
way without prior written permission. 
 
Individual subject data obtained during this study are confidential and will not be disclosed to third parties 
with the following exceptions: 
1. 
When the data is needed by the subject’s personal physician or other medical personnel 
responsible for the subject’s welfare. 
2. 
For data inspection and verification by Check-Cap Ltd. or designee, United States Food and 
Drug Administration, European Union or Israeli regulatory authority auditors or by the IRB. 
 
Any manuscript or abstract produced by the investigators must be provided to Check-Cap LTD for review 
and approval at least 60 days prior to submission. Individual subject identity cannot be divulged in any 
publication. 
 
 
 
 
 

 
 
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22 REFERENCES 
1. American Cancer Society Key Statistics for Colorectal Cancer.  Accessed online at 
https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html 
2. U.S. Preventive Services Task Force.  Final Recommendation Statement: Screening for 
Colorectal Cancer.  Accessed online at 
http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/colorectal-
cancer-screening2. The final recommendation statement can also be found in the June 15, 2016 
online issue of JAMA. 
3. Center for Disease Control (CDC) NHIS survey results as published in the CDC’s Morbidity and 
Mortality Weekly Report (MMWR) between 2006 and 2017  
4. American Cancer Society.  Colorectal Cancer Facts and Figures 2017-2019. Accessed online at: 
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-
cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2017-2019.pdf 
5. Gluck N et al. Novel prep-less X-ray imaging capsule for colon cancer screening: a feasibility 
study. Gut. 2018.  doi: 10.1136/gutjnl-2018-316127. [Epub ahead of print] 
6. Gluck N et al. Prepless CRC screening is feasible with a novel X-ray imaging capsule. 
Gastroenterology. 2018. 154(6): Supplement 1, S36-37. Accessed online at 
https://doi.org/10.1016/S0016-5085(18)30592-4 
7. Smith M et al. Insurance Coverage for CT Colonography Screening:  Impact on Overall Colorectal 
Cancer Screening Rates. Radiology, 2017, (284)3: https://doi.org/10.1148/radiol.2017170924.  
Accessed at https://pubs.rsna.org/doi/10.1148/radiol.2017170924 
8. Navarro M et al. Colorectal cancer population screening programs worldwide in 2016: an update. 
Wourld Journal of Gastroenterology. 2017. 23(20): 3632-3642. Accessed online at: 
https://www/ncbi.nlm.nih.gov/pmc/articles/PMC5449420/   
9. Gluck N et al. Clinical perfornace of a novel X-ray based imaging capsule for colonic screening. 
2017. United European Gastroenterology Journal 2017; 5 (Supplement 1) 
10. Gluck N et al. A novel prepless X-ray imaging capsule for colon cancer screening.  Gut. 2016. 
65(3): 371-373. 
11. Moshkowitz M et al. Prep-less colon cancer screening using a novel X-ray imaging. 2016. United 
European Gastroenterology Journal 2016; 2 (Supplement 1) 
12. Gluck N et al. A novel preparation-free X-ray imaging capsule for colon cancer screening: Safety 
and correlation capsule and colonoscopy clinical findings.  Gastroenterology. 2016, 150(4); 
Supplement 1, S29.  Accessed online at https://doi.org/10.1016/S0016-5085(16)30223-2 
13. Schreuders EH, et al. Colorectal Cancer Screening: a global overview of existing programs. Gut 
2015, 64(10): 1637-49. doi:10.1136/gutjnl-2014-309086 
14. Arber N, Moshkowitz M and Gluck N.  A novel prep-less X-ray imaging capsule for colon cancer 
screening:  safety and preliminary human tests.  United European Gastroenterology Journal 
2015; 2 (Supplement 1) 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
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23 APPENDICES: 
• 
Subject’s Satisfaction Questionnaire 
• 
Subject’s Satisfaction Questionnaire-Colonoscopy 
 
 

 
 
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23.1 ATTACHMENT 1: SUBJECT’S SATISFACTION QUESTIONNAIRE 
Subject Satisfaction Questionnaire 
Please circle the most appropriate answer for each question according to the following scale: 
1. Strongly disagree 
2. Disagree 
3. Neither agree or disagree 
4. Agree 
5. Strongly agree 
Space is provided for comments. 
Scale 
1. I have not experienced any inconvenience during the C-Scan procedure. 
If 1 or 2 are given, please explain: 
1 2 3 4 5 
2. I have not experienced any pain during the C-Scan procedure. 
If 1 or 2 are given, please explain: 
1 2 3 4 5 
3. I did not need any analgesic or other pain medication during the C-Scan procedure. 
If 1 or 2 are given, please explain: 
1 2 3 4 5 
4. I have not experienced any inconvenience while ingesting the contrast media 3 times a day 
If 1 or 2 are given, please explain: 
1 2 3 4 5 
5. I Would recommend the C-Scan procedure for colonic screening 
If 1 or 2 are given, please explain: 
1 2 3 4 5 
6. The C-Scan procedure didn’t affect my daily routine 
If 1 or 2 are given, please explain: 
1 2 3 4 5 
7. I have not experienced any inconvenience during capsule excursion 
If 4 or 5 are given, please specify: 
1 2 3 4 5 
8. Do you have any additional comments regarding the C-Scan procedure? 
 

 
 
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Clinical Investigational Plan For Study CL-SY-02-0096 
 
Document No. 
DOC001593  
Revision 
03 
 
 
24-June-2019 
 
Page 45 of 45 
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The information contained in this document is confidential and the sole property of “Check-Cap” 
Any reproduction in part or whole without the written permission of “Check-Cap” is prohibited 
 
 
23.2 ATTACHMENT 3: SUBJECT’S SATISFACTION QUESTIONNAIRE-COLONOSCOPY 
 
 
Subject Satisfaction Questionnaire 
Please circle the most appropriate answer for each question according to the following 
scale: 
1. Strongly disagree 
2. Disagree 
3. Neither agree or disagree 
4. Agree 
5. Strongly agree 
Space is provided for comments. 
Scale 
1. I have not experienced any inconvenience during the Colonoscopy procedure. 
Please explain: 
1 2 3 4 5 
2. I have not experienced any pain during the Colonoscopy procedure. 
Please explain: 
1 2 3 4 5 
3. I did not need any analgesic or other pain medication during the 
Colonoscopy procedure. 
Please explain: 
1 2 3 4 5 
4. The C-scan procedure was easier for me compare to the Colonoscopy procedure 
Please explain: 
1 2 3 4 5 
5. For my next colonic screening I will prefer the C-Scan procedure 
Please explain: 
1 2 3 4 5 
6. Please specify the advantages of the C-Scan ver. Colonoscopy in your opinion: 
 
7. Do you have any additional comments regarding the C-Scan procedure?