A Study on the Effectiveness of Artificial Intelligence-assisted Colonoscopy in Improving the Effect of Colonoscopy Training for Trainees
Phase: NA
Conditions: Colonoscopy, Artificial Intelligence, Gastrointestinal Disease
Sponsor: Renmin Hospital of Wuhan University

EndoAngel Study 
Versio 1.0/May 18,2021 
 
 
 
 
 
Multi-center Study on the Effectiveness and Safety 
of Artificial Intelligence Assisted System in the Clinical 
Application of Digestive Endoscopy 
Subtopic 4: Study on the effectiveness of artificial intelligence 
assistant system in improving the training effect of advanced physicians' 
enteroscopy 
 
 Short Title:EndoAngel Study 
 
 
 
 
NCT 
- 
Trial number 
EA-21-005 
Protocol version 
1.0 
Version Date 
May 18,2021 
Country 
China 
Principal investigator 
Professor Yu Honggang 
Departments 
Endoscopic Centre 
Address 
99 Zhangzhidong Road, Wuchang District, Wuhan,Hubei 

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目录 
1 
Summary ............................................................................................................................. 4 
1.1 
Time and Event Tables .................................................................................................... 5 
1.2 
Flow chart ....................................................................................................................... 6 
2 
Introduction ......................................................................................................................... 6 
3 
Selection .............................................................................................................................. 7 
3.1 
Endoscopic physician ...................................................................................................... 7 
3.2 
Patients ............................................................................................................................ 7 
3.3 
Definition of enrollment.................................................................................................. 8 
4 
Endpoints ............................................................................................................................ 8 
4.1 
Primary Endpoint ............................................................................................................ 8 
4.2 
Secondary Endpoints ...................................................................................................... 8 
4.3 
Safety evaluation endpoints and other secondary endpoints ......................................... 10 
5 
Purpose and overall design ............................................................................................... 10 
5.1 
Purpose .......................................................................................................................... 10 
5.2 
Overall design ............................................................................................................... 10 
6 
Study process .................................................................................................................... 10 
6.1 
Summary of Study Process ........................................................................................... 10 
6.2 
Enrollment .................................................................................................................... 11 
6.2.1Informed Consent ...................................................................................................... 11 
6.2.2 Patient Selection ....................................................................................................... 12 
6.2.3 Subject identification number .................................................................................. 12 
6.3 
Treatment Description ................................................................................................... 12 
6.3.1 Patient Screening Assessments ................................................................................ 13 
6.3.2 Pre-Procedure Managements ................................................................................... 13 
6.3.3 Intraoperative Managements .................................................................................... 13 
6.3.4 Post-operative Managements ................................................................................... 13 
6.3.5 Specimen Processing Procedures ............................................................................. 14 
6.4 
Suspension and withdrawal ........................................................................................... 14 
6.4.1 Pre-Procedure ........................................................................................................... 14 
6.4.2 Intraprocedure .......................................................................................................... 14 
6.4.2 Replacement ............................................................................................................. 15 
6.5 
Randomization and Blinding ........................................................................................ 15 
6.5.1 Randomization Implementation ............................................................................... 15 
6.5.2 Blinding Implementation and Protection ................................................................. 15 
6.5.3 Unblinding ............................................................................................................... 16 
6.6 
Concomitant therapy and medication............................................................................ 16 
7 
Basis of study protocol and risk/benefit analysis .............................................................. 16 
7.1 
Selection of endpoints ................................................................................................... 17 
7.2 
Definition of participants .............................................................................................. 17 
7.3 
Adverse events .............................................................................................................. 17 
7.4 
Expected and trial-related adverse events ..................................................................... 18 
7.5 
Risk minimization ......................................................................................................... 18 

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7.6 
Related benefits ............................................................................................................. 19 
7.7 
Overall feasibility analysis ............................................................................................ 19 
8 
Statistical Analysis ............................................................................................................ 19 
8.1 
Statistical Analysis Plan ................................................................................................ 19 
8.2 
Methods ........................................................................................................................ 19 
8.3 
Sample Size Calculation ............................................................................................... 20 
8.4 
Statistical analysis set ................................................................................................... 20 
9 
Device Description ............................................................................................................ 20 
10 
Abbreviations ................................................................................................................ 21 
 
 
 

EndoAngel Study 
Versio 1.0/May 18,2021 
 
1 
Summary 
Title： 
Multi-center Study on the Effectiveness and Safety of Artificial 
Intelligence Assisted System in the Clinical Application of Digestive
Endoscopy 
Subtopic 4: Study on the effectiveness of artificial intelligence
assistant system in improving the training effect of advanced 
physicians' enteroscopy 
Short Title： 
EndoAngel Study 
Trial number： 
EA-21-005 
Research system 
EndoAngel 
Expected effect： 
To explore whether the AI-assisted system(EndoAngel) can promote
the operation training of beginners' colonoscopy. 
Primary Endpoint： 
1. 
CUSUM learning curve for colonoscopy (ACE scoring scale) 
2. 
The difference in average test scores before and after the 
training 
Secondary Endpoints: 
1 
Detection rate of advanced adenoma  
2 
Polyp Detection Rate, PDR 
3 
Average number of adenomas detected per patient 
4 
The detection rate of large, small and micro polyps 
5 
The average number of large, small and micro polyps detected 
6 
The detection rate of large, small and micro adenomas 
7 
The average number of large, small and micro adenomas 
detected 
8 
The detection rate of adenoma in different sites 
9 
The average number of adenomas detected in different sites
Number of missed return of the sliding endoscopy/number of 
successful return of the sliding endoscopy 
10 Real-time gut cleanliness score 
11 Withdraw overspeed percentage 
12 The withdraw time 
13 Ratio of ileocecal reach 
Trail design： 
Prospective, randomized controlled, intervention, multi-center study 
Participants： Male and female subjects aged 50 years or older will require colonoscopy, and
voluntarily provide imaging data ofcolonoscopy, and sign an informed consent 
form. 
Sample size： 
385 samples needed to be enrolled 

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Study Process： 1.Subjects meeting all inclusion criteria and those failing all exclusion criteria
were included in the study before colonoscopy; 
2.Include qualified novice doctors for colonoscopy training 
3. Patients who met the requirements were enrolled and randomly assigned as 
follows 
The experimental group: received painless colonoscopy training with the
assistance of the artificial intelligence assistant system, which could prompt
abnormal lesions and real-time withdrawal speed, and feedback the overspeed 
percentage. 
Control group: routine painless enteroscopy training, no special tips. 
4.After colonoscopy, the teacher scored the colonoscopy using ACE scoring 
scale 
Security 
Safety incidents shall be evaluated and reported according to the quality 
management measures for clinical trials of medical devices 
 
1.1 
Time and Event Tables 
 
 
 
Eents/visits 
Screening 
period (d -30~-1) 
The 
day 
of 
colonoscopy(d 0) 
Follow-up(d 1-
14) 
Informed Consent 
X 
 
 
Demographic 
information 
X 
 
 
Urine/blood pregnancy 
test 
X 
 
 
Medical history/surgical 
history 
X 
 
 
physical examination 
X 
 
 
Selection/exclusion 
criteria 
X 
 
 
colonoscopy 
 
X 
 
Accompanying therapy 
X 
X 
 
Accompanying 
medication 
X 
X 
 
Adverse events 
 
X 
X 
Pathological findings 
 
 
X 
Research completed 
 
 
X 

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1.2 
Flow chart 
 
2 
Introduction 
Endoscopic diagnosis and treatment play an important role in the discovery and treatment of 
digestive tract diseases. Common endoscopic examination includes gastroscopy, colonoscopy, 
enteroscopy, 
capsule 
endoscopy, 
ultrasound 
gastroscopy, 
endoscopic 
retrograde 
cholangiopancreatography and other related techniques, which can be used in the diagnosis and 
follow-up of early gastric cancer, peptic ulcer, esophageal varices, precancerous lesions, intestinal 
polyps, intestinal adenomas, bowel cancer lesions, inflammatory bowel diseases, pancreatic diseases, 
biliary diseases, etc. At present, digestive endoscopy almost covers the diagnosis of most diseases of 
the digestive tract, and the digestive system diseases that can not be seen in the direct visual field of 
endoscope can also be realized by the related techniques based on ultrasound endoscopy, ERCP and 
other endoscopy (we call endoscopy here), so as to achieve the coverage of the whole digestive 
system. It can be seen that digestive endoscopy is of great significance for the diagnosis and 
development of digestive system diseases. At present, the demand for endoscopic examination in 
China is high, and the supply of endoscopic surgery in hospitals is short of supply, which puts forward 
high requirements for the proficiency and accuracy of operation doctors. 

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In recent years, deep learning has developed rapidly in the field of medicine.Andre Esteva 
et al. used deep neural networks (DNN) to classify skin cancer to an expert level. Our previous 
experiments show that deep learning has high accuracy in endoscopic quality monitoring, 
which can effectively standardize the operation of doctors, reduce the blind area of examination, 
and improve the quality of endoscopic examination. At the same time, it can also monitor the 
doctor's withdrawal time and improve the detection rate of adenoma. in the previous work of 
our group, we have successfully developed a deep learning-based enteroscopy speed 
monitoring, intestinal cleanliness evaluation, and in clinical trials to verify the effectiveness of 
artificial intelligence model in improving the quality of gastroscopy, enteroscopy. 
Based on the above rich foundation of preliminary work and the huge demand in the field 
of colonoscopy training, we intend to train beginners in colonoscopy operation by comparing 
the cases of EndolAngel assistance and no EndolAngel assistance. To explore whether AI can 
promote the training of colonoscopy for beginners. 
3 
Selection 
The subjects in this study were divided into endoscopists and colonoscopy patients. The 
endoscopists were required to be beginners without independent experience in colonoscopy, 
and the colonoscopy patients were male or female ≥50 years old who needed to undergo 
colonoscopy screening, volunteered to provide endoscopic imaging data and signed informed 
consent, and such patients were included in the study.50 years of age is the recommended age 
for the first colonoscopy screening, so the investigation of subjects ≥50 years of age can better 
represent the quality of the colonoscopy test population。 
3.1 Endoscopic physician 
 
Inclusion criteria 
Novice colonoscopists without previous experience in independent colonoscopy; 
 
Exclusion criteria 
1）The number of operating cases does not meet the requirement of sample size 
2）could not provide informed consent 
3.2 Patients 
 
Inclusion criteria 
1) 
Male or female ≥50 years old; 
2) 
Able to read, understand and sign informed consent 
3) 
The investigator believes that the subjects can understand the process of the clinical 
study, are willing and able to complete all study procedures and follow-up visits, and 

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cooperate with the study procedures 
4) 
Patients requiring colonoscopy 
 
Exclusion criteria 
1) 
Have drug or alcohol abuse or mental disorder in the last 5 years 
2) 
Pregnant or lactating women 
3) 
Patients with known multiple polyp syndrome; 
4) 
patients with known inflammatory bowel disease; 
5) 
known intestinal stenosis or space-occupying tumor; 
6) 
known colon obstruction or perforation; 
7) 
patients with a history of colorectal surgery; 
8) 
Patients with previous history of allergy to pre-used spasmolysis; 
9) 
Unable to perform biopsy and polyp removal due to coagulation disorders or oral 
anticoagulants; 
10) High risk diseases or other special conditions that the investigator considers the 
subject unsuitable for participation in the clinical trial 
3.3 Definition of enrollment 
After participants signed informed consent, they were randomized before colonoscopy. 
The randomization time was the enrollment time, and was recorded in CRF. 
 
4 
Endpoints 
 
4.1 Primary Endpoint 
1) 
CUSUM learning curve for colonoscopy (ACE scoring scale) 
2) 
 Average test score difference before and after training 
4.2 Secondary Endpoints 
1) 
Detection rate of advanced adenoma：the numerator is the number of patients 
diagnosed with advanced adenomas, and the denominator is the total number of 
patients undergoing colonoscopy,Advanced adenoma was defined as > 10mm 
adenoma, villous adenoma, tubular villous adenoma, high-grade intraepithelial 
neoplasia, and carcinoma. 

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2) 
Polyp Detection Rate, PDR：the numerator is the number of patients with polyps 
detected by colonoscopy, and the denominator is the total number of patients who 
underwent colonoscopy 
3) 
Average number of adenomas detected per patient：the numerator is the total 
number of adenomas detected by colonoscopy, and the denominator is the total 
number of patients undergoing colonoscopy. 
4) 
The detection rate of large, small and micro polyps:the numerator is the number of 
patients with large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) polyps 
detected by colonoscopy, and the denominator is the total number of patients 
receiving colonoscopy. 
5) 
The average number of large, small and micro polyps detected:the numerator is the 
total number of large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) polyps 
detected by colonoscopy, and denominator is the total number of patients undergoing 
colonoscopy. 
6) 
The detection rate of large, small and micro adenomas:the numerator is the number 
of patients with large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) 
adenomas detected by colonoscopy, and the denominator is the total number of 
patients receiving colonoscopy. 
7) 
The average number of large, small and micro adenomas detected:the numerator is 
the total number of large (≥10 mm), small (6-9 mm) and micro-small (≤5 mm) 
adenomas detected by colonoscopy, and denominator is the total number of patients 
undergoing colonoscopy. 
8) 
The detection rate of adenoma in different sites:the numerator is the number of 
patients with adenomas detected in the rectum, sigmoid colon, descending colon, 
transverse colon, ascending colon, ileocecal region and other sites during 
colonoscopy, and the denominator is the total number of patients receiving 
colonoscopy. 
9) 
The average number of adenomas detected in different sites:the numerator is the 
total number of adenomas detected in the rectum, sigmoid colon, descending colon, 
transverse colon, ascending colon, ileocecal region and other sites during 
colonoscopy, and the denominator is the total number of patients undergoing 
colonoscopy. 
10) Number of missed return of the sliding endoscopy/number of successful return of 
the sliding endoscopy:the numerator is the total number of sliding endoscopy during 
colonoscopy, and the denominator is the number of sliding endoscopy and 
successful return endoscopy during colonoscopy 
11) Real-time gut cleanliness score:during colonoscopy, a real-time intestinal cleanliness 
score was given by EndoAngel based on the Boston-scale Boreal Preparation Score 
(BBPS). 

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12) withdraw overspeed percentage:the ratio of the overspeed duration to the total 
duration in the process of withdrawal. 
13) The withdraw time:the time between colonoscopy arrival at ileocecal valve and 
colonoscopy exit from anus. 
14) Ratio of ileocecal reach:for a period of time, the number of colonoscopies that failed 
to reach the ileocecal part accounted for the proportion of the total number of 
colonoscopies. 
4.3 Safety evaluation endpoints and other secondary endpoints 
Adverse events shall be determined according to the definition in the code for the quality 
management of adverse events of medical devices. The following types of adverse events 
should be recorded and calculated in the hospital history and CRF. According to the CRF 
table, the occurrence time, starting and ending time, intervention measures and treatment 
results should be filled in when recording. The severity should be referred to the previous 
literature and CTCAE 5.0 standard. 
5 
Purpose and overall design 
 
5.1 Purpose 
The purpose of this study is to explore whether the AI-assisted system(EndoAngel)can 
promote the operation training of beginners' colonoscopy. 
5.2 Overall design 
This is a prospective, muti-center, randomized controlled trial study. 
6 
Study process 
 
6.1 Summary of Study Process 
• If the patient meets the inclusion criteria, the patient is invited to participate in the study 
and then the informed consent procedure for the clinical trial is applied. 
• Assess patients’ eligibility based on the inclusion/exclusion criteria. 
• If the patient meets the inclusion/exclusion criteria, information prior to colonoscopy 

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will be collected 
• If the patient is enrolled, he will be randomized 
• colonoscopy is performed after informed consent. Any intraoperative adverse events are 
recorded on theCRF for submission and subsequent analysis. 
• Follow-up will be performed from the postoperative to the study completion, as detailed 
in the time and event table. 
6.2 Enrollment 
Only after patients signed the informed consent, can the research-related procedures be 
conducted. 
6.2.1Informed Consent 
According to the Helsinki Declaration, patients are not allowed to participate in the study 
without adequate informed consent. The principal investigator is responsible for ensuring that 
no patient was enrolled in the study without adequate informed consent. Failure to obtain 
informed consent and failure to document this process is considered a violation of the Helsinki 
Declaration and the study protocol. 
All informed consent documents (ICDs) must be approved by ethics. Patient’s informed 
consent requires documentary record on the informed consent by himself in his primary 
language. 
The investigator or trained designated person performs a preliminary screening to 
determine if the patient generally meets the eligibility criteria for the study. If yes, the 
investigator or trained designee should recommend the patient to participate in the study. If the 
patient agrees to participate, they will need to sign an informed consent document. 
The investigator or trained designated person should confirm that the subject understands 
the following points in the study: 
• 
The purpose of research, 
• 
Potential risks or adverse events, 
• 
Potential risks or adverse events directly related to participating the research, 
• 
The likelihood of failure, 
• 
Research requirements include follow-up visits, 
• 
All rights of the subject as a participant in the clinical study. 

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After explaining the purpose of the study, the investigator or trained designee should 
answer any questions from the subject. If the subject agrees to participate, his or her wishes 
must be recorded by signing and dated on the EC-approved ICF, and the document should be 
signed and dated by the patient receiving the informed consent. 
After successful completion of the informed consent process, the investigator or trained 
designated person will assess the eligibility of patients based on the protocol. 
6.2.2 Patient Selection 
All endoscopists and patients who needed colonoscopy agreed to use their results for 
correlation analysis, were screened based on the inclusion/exclusion criteria. Patients who 
passed the screening were enrolled and recorded in the subject screening and enrollment tables. 
There is no bias in the choice of the enrolled subjects. The date of screening, the results 
(enrolled or not), and the primary reason for not selecting subjects (such as not meeting 
inclusion criteria, or not interested in participating in the study) will be recorded. 
After the patients are enrolled, the research center should complete the 
preoperative study data collection. 
It is desirable to be able to collect complete data for all enrolled patients, without who 
withdrawal from the study. 
6.2.3 Subject identification number 
Each subject is numbered after obtaining informed consent. 
The colonoscopist number starts with EAE as a fixed number and starts with 0001 according 
to the time of obtaining the informed consent.For example, subject No. 1 signed the informed 
consent was EAE0001, followed by subject No. 2, EAE0002. 
The colonoscopy patients were numbered starting with EA as a fixed number and starting with 
0001 according to the time of obtaining the informed consent.For example, the number of the 
first subject to sign the informed consent in Southern Medical was EA0001, followed by the 
second subject EA0002. 
Once the subject identification number is assigned, the number is not reusable. 
6.3 Treatment Description 
This section applies to individuals who have signed an approved informed consent and 

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have been identified as eligible to participate in this study on the basis of the inclusion and 
exclusion criteria. This section introduces the preoperative, surgical and postoperative 
management of subjects in detail. 
6.3.1 Patient Screening Assessments 
1） History 
2） Physical examination 
3） Hematuria pregnancy test (if required) 
6.3.2 Pre-Procedure Managements 
1） Fasting for 6 hours and water deprivation for 2 hours before examination  
2） Routine intestinal preparation. 
3） Psychological counseling. 
4） Performing routine anesthesia for painless colonoscopy patients. 
6.3.3 Intraoperative Managements 
1） Patient position: prone position with appropriate restraint. 
2） Insertion route: according to the actual situation of the subject, usually through the 
anus 
3） Patients in the control group received colonoscopy without AI assistance, and 
patients in the experimental group received colonoscopy with AI assistance.The 
advanced physician carries on the colonoscopy examination under the teacher's 
guidance. 
4） After the examination, the teacher scored the colonoscopy according to the ACE 
scoring scale. 
6.3.4 Post-operative Managements 
1） Postoperative routine nursing 
2） The anesthetized subjects were observed until they woke up 
3） Patients with no lesions such as polyps were followed up until they woke up and left 

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the endoscopic room. 
4） Clinical information such as the examining physician, duration of examination, 
sedation status, whether to ileocecal reach,  bowel readiness, complications, polyp 
characteristics (number, location, size, color, and shape), and pathological results 
will be collected and recorded in a Web-based data management system. 
5） The images and video data were collected for the functional evaluation of 
EndoAngel, such as the withdrawal speed , the number of sliding  not 
returned/sliding  returned, real-time intestinal preparation score, polyp detection 
and typing, etc. 
6.3.5 Specimen Processing Procedures 
 
6.4 Suspension and withdrawal 
Patients who were screened and confirmed to be eligible for the study, signed the 
informed consent and completed the randomization were considered as enrolled. If serious 
program deviation, withdrawal, or death occurs, the subject study is considered to be suspended. 
If the subject discontinues the study after obtaining informed consent, the data before the 
discontinuation will still be included in the study-related analysis. 
6.4.1 Pre-Procedure 
In any time during the study period, even before Colonoscopy, participants could 
withdraw their informed consent whenever necessary. Researchers can withdraw participants 
before surgery according to safety considerations in the inclusion and exclusion criteria. 
6.4.2 Intraprocedure 
For safety reasons, the investigator may have the subject quit during the procedure. 
For example, the patient is not suitable for receiving the instrument for the study or the 
endoscopists do not use the specified instrument for any reason. If the following serious 

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cases occur, please withdraw during the operation: 
a) perforation 
b) bleeding 
c) allergy to narcotic drugs 
d) Intestinal cleanliness is very poor, endoscopic physicians can not smoothly 
advance: a single intestinal segment is less than 1 point 
e) can not complete colonoscopy due to obstruction, intolerance, inflammatory bowel 
disease or colorectal resection 
f) can not biopsy due to coagulation dysfunction or oral anticoagulants 
6.4.2 Replacement 
Subject will be deemed to have commenced the study upon completion of the 
informed consent process, and any subject who has been discontinued prior to or during 
the Colonoscopy will not subsequently be replaced by other subjects 
6.5 Randomization and Blinding 
6.5.1 Randomization Implementation 
Randomization is conducted according to the study protocol, and the random contents are 
implemented in an electronic system block-randomized manner (n = 4; experimental 
group/control group = 1). Randomization prior to Colonoscopy to decide whether to use 
EndoAngel. The researchers randomized the random results generated by the electronic system, 
and the generated random results were stored in the research center. The random time (accurate 
to minute), random person, subject number and acronym were recorded in the corresponding 
positions of the electronic system. 
6.5.2 Blinding Implementation and Protection 
Subjects and evaluators are blinded according to the protocol. 
Randomization results will be kept confidential to the subjects in general. Randomization 
results are not reflected in inpatient history and other subject access documents. During and 
after the examination, study personnel should take care not to talk to the subject about the results 
of the randomization to avoid unnecessary unblinding 

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The assessors are blinded, and the data analysis team and pathologists could not obtain 
the randomization results from the medical history data. 
6.5.3 Unblinding 
Uncovering or breaking the blindness means displaying the randomized results to the 
subjects or evaluators. Researchers should protect the blind method as far as possible. 
Uncovering the randomized results of a single subject may lead to the leakage of the 
randomized results of other subjects. Any leakage of the randomized results will have a 
significant impact on statistical analysis. In general, it is prudent to deal with the disclosure of 
blind law. In the following cases, it is possible to consider the disclosure of blind law: 
1) 
endangering the safety of subjects: For example, in some serious adverse events, 
subjects need to know the randomized results to inform other physicians to take appropriate 
emergency treatment. 
2) 
Threatening the safety of the assessor: When the assessor is facing potential safety 
hazards, he needs to know the randomization results. 
3) 
Compliance: For reasons of partial compliance, in certain circumstances, if the 
research instruments and cases involved in unexpected adverse events are needed, the results 
of randomization should be made public to the relevant departments or the public. 
5) Other management reasons. 
6.6 Concomitant therapy and medication 
The concomitant treatment and concomitant medication were recorded from the time the 
subject signed the informed consent to the time the study was completed. Concomitant 
treatment and concomitant medication should be recorded in the CRF, or a clear copy of the 
form available from the research center should be kept in the CRF as research data to identify 
other factors affecting the end of the study. When recording the concomitant treatment and 
concomitant medication, the indications and the starting and ending time of use should be 
clearly defined, and the corresponding types of adverse events should be indicated for the 
treatment measures to cope with adverse events. When using a copy of the study center form, 
the investigator should sign the copy and indicate the date of review to confirm that the 
document is a study document. 
7 
Basis of study protocol and risk/benefit analysis 

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EndoAngel is used to provide assistant to monitor the operation of endoscopists, which 
will not provide diagnosis. Doctors make their own diagnosis on the basis of EndoAngel's 
results. The security of the software and the improvement of endoscopic physician's diagnosis 
and treatment level have also been confirmed in the previous feasibility study. And the patients 
in this study carry out the diagnosis and treatment according to the conventional treatment 
measures, which are formulated in accordance with the standard medical treatment procedures 
and do not increase the risk of the subjects. 
7.1 Selection of endpoints 
The primary endpoints are:1) the CUSUM learning curve for colonoscopy (ACE scoring 
scale); 2) the average test score difference before and after training. 
The secondary endpoints are: 1)Detection rate of advanced adenoma;2)Polyp Detection 
Rate, PDR;3)Average number of adenomas detected per patient;4)The detection rate of large, 
small and micro polyps;5)The average number of large, small and micro polyps detected; 
6)The detection rate of large, small and micro adenomas;7)The average number of large, 
small and micro adenomas detected;8)The detection rate of adenoma in different sites;9)The 
average number of adenomas detected in different sites;10)Number of missed return of the sliding 
endoscopy/number of successful return of the sliding endoscopy;11)Real-time gut cleanliness 
score;12)Withdraw overspeed percentage;13)The withdraw time;14)Ratio of ileocecal reach 
Adverse events in safety indicators shall be judged in accordance with relevant 
regulations, and serious adverse events shall be recorded and reported in accordance with 
regulations. 
Other evaluations are detailed in the Case Report Form (CRF). 
7.2 Definition of participants 
Patients were included according to the indications and contraindications described in 
the use plan. Because of practical reasons (such as younger patients, participation in a 
number of clinical studies, alcohol/drug dependence patients, and other factors that may 
affect the completion and/or reliability of gastroscopy) and ethical reasons (whether 
informed consent can be completed, etc.), the entry and discharge criteria have been 
reduced. 
7.3 Adverse events 
The relevant definitions of adverse events are as follows: 

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Adverse Events (AE): Any adverse medical event, unexpected disease or injury, or 
adverse clinical manifestations (including abnormal laboratory findings) that occur in a subject, 
user or other person, whether or not associated with medical devices. 
Serious Adverse Events (SAE): Adverse Events with the following information: 
- 
causing death. 
- 
leading to severe deterioration of the health of the subjects, including 
- 
leading to life-threatening diseases or injuries, 
- 
Causing impairment of body structure or function. 
- 
Need hospitalization or extended hospitalization 
- 
lead to hospitalization and preventive medical or surgical intervention 
- 
Permanent damage to body structure or function 
- 
Fetal distress, fetal death or congenital abnormalities or congenital defects. 
Note: Hospitalization for existing conditions, or surgery required in the program, without 
serious deterioration of health status, is not considered a serious adverse event. Purposeful 
hospitalization, such as economic or reimbursement reasons, is not considered a serious 
adverse event. 
Unexpected adverse device response (UADE): refers to adverse events related to medical 
devices that were not previously identified in the current version of the risk analysis report in 
terms of nature, severity or incidence. The definition includes any event caused by insufficient 
or inadequate description of the use or deployment of the device. This definition includes any 
event caused by a user's error. 
7.4 Expected and trial-related adverse events 
Previous studies have shown that the expected adverse events are basically the same as 
the complications of conventional endoscopic diagnosis and treatment. 
The instrument used in this experiment is a medical software which is not in 
contact with human body. There is no difference between the experimental operation and 
the routine operation. The intervention measures (such as randomized process) in the 
experiment may slightly increase the incidents of diagnosis and treatment. 
7.5 Risk minimization 

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In this study, when there are bugs in the software, doctors can still operate under their 
own judgment without affecting conventional diagnostic and treatment measures, greatly 
reducing the risk of the test. 
7.6 Related benefits 
According to the results of previous multi-center randomized controlled trials, it has 
been proved that EndoAngel can improve the examination quality of colonoscopists. In this 
observational study, subjects receiving EndoAngel assisted colonoscopy may obtain higher 
quality colonoscopy due to the subject effect of colonoscopists. 
7.7 Overall feasibility analysis 
EndoAngel is an independent system including both software and computer hardware, 
which can monitor image data 24 hours a day. The system is not invasive. The overall 
operability is strong. 
8 
Statistical Analysis 
 
8.1 Statistical Analysis Plan 
Data management and statistical analysis were implemented by Renmin Hospital of 
Wuhan University. 
8.2 Methods 
Continuous variables should be described by number of subjects, mean, standard 
deviation, median, minimum and maximum. The classification variables are summarized by 
frequency and percentage. 
Spearman rank correlation analysis was used to analyze the correlation between 
endoscopic overspeed percentage / intestinal preparation score and adenoma detection rate / 
advanced adenoma detection rate / polyp detection rate. 
Univariate analysis was used to analyze the correlation between the number of 
unreturned slides/returned slides and the detection rate of adenoma/late adenoma/polyp. 
Chi-square analysis was used to analyze the detection rate of adenomas in different 
scores of intestinal segments. 

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8.3 Sample Size Calculation 
The main evaluation focus of this project plan is to evaluate whether there is a 
significant difference in ACE scores of colonoscopy training for endoscopic physicians by 
using EndoAngel.This project plans to carry out clinical trials in 3 hospitals. According to the 
literature, we assume that the cognitive score of endoscopists can be increased from 2.5 to 2.8 
after intervention, then 126 cases of colonoscopy need to be enrolled, and if the motor score of 
endoscopists is increased from 2.38 to 2.59, then 350 cases need to be enrolled.Considering 
the experimental abscission rate of 10%, a total of 385 cases of colonoscopy should be 
included. 
8.4 Statistical analysis set 
All patients who met the inclusion and exclusion criteria were considered eligible for 
recruitment. 
The two analysis sets in this study are defined as follows: 
• The full analysis set (FAS) population analysis set will contain all eligible cases and 
shedding cases, but does not include culling cases. 
• The Compliance (PP) population analysis set will include all subjects in the FAS 
analysis set with no significant deviation from the program. 
Intention-to-treat and conformity analysis sets should be used to analyze the primary 
efficacy endpoints. The main analysis will be based on the PP analysis set. FAS analysis was 
regarded as supportive analysis. 
9 
Device Description 
EndoAngel 
Version:EA2301 
 
 

EndoAngel Study 
Versio 1.0/May 18,2021 
 
10 Abbreviations 
Abbreviati
ons 
Full Name 
Chinese 
AE 
Adverse Event 
不良事件 
CFDA 
China Food and Drug Administration 
国家食品药品监督管理总
局 
CNDA 
China National Drug Administration 
国家食品药品监督管理总
局 
CRF 
Clinical Record File 
病例报告表 
CTCAE 
Common Terminology Criteria for Adverse 
Events 
不良事件常规评价标准 
EC 
Ethical Committee 
伦理委员会 
ICD 
Informed Consent Document 
知情同意文件 
ICF 
Informed Consent Form 
知情同意书 
ITT 
Intention to Treat 
意向治疗分析集 
PP 
Per Protocol 
符合方案集 
SAE 
Serious Adverse Event 
严重不良事件 
 
 
 

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Informed Consent Form 
“Study on the effectiveness of artificial intelligence 
assistant system in improving the training effect of advanced 
physicians' enteroscopy” 
Informed Consent Form for clinical study subjects 
Informed Consent Form: Information page 
Release date: 1.0,18 May 2021 
Principal investigator: Yu Honggang 
Dear sir / Madam, 
We will invite you to participate in a clinical study “Study on the effectiveness of artificial 
intelligence assistant system in improving the training effect of advanced physicians' 
enteroscopy”. During this study, we will use a AI-assisted system which do not interfere the 
physician's original observations and procedures. 
Before you decide whether to participate in the study, please read the following as 
carefully as possible to help you understand the study and why it was conducted, the procedure 
and duration of the study, the potential benefits or risks of participating in the study. If you 
wish, you can discuss it with your family or friends, or ask your doctor for an explanation to 
help you make a decision 
1. 
Background and Purpose 
Colonoscopy is a key technique for detecting and diagnosing lesions of the lower 
digestive tract.High-quality endoscopy results in better disease outcomes.However, at present, 
the demand for endoscopic examination is high in China, and the hospital endoscopic surgery 
is in short supply.Shortening the colonoscopy learning cycle of endoscopists is of great 
significance to solve the problems of the lack and uneven distribution of digestive endoscopists 
and the substandard quality of endoscopy in China. 
EndoAngel is a multi-functional intelligent digestive endoscopy assistant system 
integrating lesion auxiliary diagnosis and examination quality control, which has the 
characteristics of intelligence and less time consumption. The real-time assistance of 

EndoAngel Study 
Versio 1.0/May 18,2021 
EndoAngel in the examination process can indicate the endoscopic physician's arrival at the 
ilocecal part, the time of  withdrawal, the speed of  withdrawal, whether the endoscope slides, 
and the polyps in the field of vision. At present, the clinical verification of various functions 
of EndoAngel, an endoscopic assistant system based on artificial intelligence, has been carried 
out in our center. This project plans to conduct a prospective, multi-center clinical trial to verify 
the functions of EndoAngel, so as to prove that EndoAngel can improve the colonoscopy 
ability of novice physicians and shorten the training cycle of colonoscopes. 
2. 
Who can participate in the study 
1） Male or female ≥50 years old; 
2） Able to read, understand and sign informed consent 
3） The investigator believes that the subjects can understand the process of the clinical 
study, are willing and able to complete all study procedures and follow-up visits, and cooperate 
with the study procedures 
4） Patients requiring colonoscopy 
3. 
Who can not participate in the study 
1） Have drug or alcohol abuse or mental disorder in the last 5 years 
2） Pregnant or lactating women 
3） Patients with known multiple polyp syndrome; 
4） patients with known inflammatory bowel disease; 
5） known intestinal stenosis or space-occupying tumor; 
6） known colon obstruction or perforation; 
7） patients with a history of colorectal surgery; 
8） Patients with previous history of allergy to pre-used spasmolysis; 
9） Unable to perform biopsy and polyp removal due to coagulation disorders or oral 
anticoagulants; 
10） High risk diseases or other special conditions that the investigator considers the 
subject unsuitable for participation in the clinical trial 
4. 
What would you need to do 
Patients need to prepare for Colonoscopy routinely, fasting for at least 6 hours and 
water deprivationfor at least 2 hours before the procedure. Patients undergoing painless 
operation receive general anesthesia, If you are assigned to the experimental group, the 
endoscopists will be assisted by EndoAngel, which can be used for colonoscopy quality 
monitoring and lesion indication in real time. If you are assigned to the control group, the 

EndoAngel Study 
Versio 1.0/May 18,2021 
endoscopist performs conoloscopy routinely without specialprompts. You are equally 
likely to be in the above two groups. 
5. 
Benefits 
You will be randomized into the experimental group and the control group. The 
endoscopists in the experimental group will be assisted by EndoAngel, which can can be 
used for colonoscopy quality monitoring and lesion indication in real time. Patients who 
receive EndoAngel-assisted colonoscopy are likely to have higher quality and more 
comprehensive information about their disease.and lower incidences of adverse events. 
6. 
Adverse events 
The adverse events are basically the same as the complications of conventional 
endoscopic diagnosis and treatment. Participants in this study do not increase other 
additional risks. 
7. 
Related fees 
In this study, patients only need to bear the cost of routine colonoscopy without additional 
costs. 
8. 
Personal Information 
During colonoscopy, your endoscopic electronic image and case information will be 
collected and stored in the hospital.Your doctor, the researcher, will be given access to this 
electronic information for scientific research and the development of new medical 
technologies.Any public reporting of relevant research and development results will not 
disclose your personal identity. 
When the study is over, we will analyze the data.You will have the opportunity to be 
informed of the study results.You can ask your research physician about the study results and 
ask for an explanation.The results of this study may also be published in journals and may be 
reported at conferences, but will not contain any information that might identify you.To ensure 
privacy, records or samples released for research purposes will not be accompanied by your 
name and other identifying information.Instead, your information will be identified only by a 
code.Only the research physician and authorized personnel will be able to associate this code 
with your name through a checklist that will be securely kept at the research center.It may be 
that in order to ensure that the research is conducted in a regulated way in the research center, 
the sponsor, the ethics review committee, and the governmental authorities may have access to 
your data as required. They are bound by the obligation of confidentiality and will not violate 

EndoAngel Study 
Versio 1.0/May 18,2021 
your privacy. 
9. 
For more information 
You can ask any question about this study at any time. 
Your doctor will give you his or her phone number so that he or she can answer 
your questions 
Your doctor will keep you informed if there is any important new information during the 
course of the study that may affect your willingness to continue participating in the study. 
10. Participation and withdrawal are voluntary 
Participation in the study is entirely up to you. You may refuse to participate in the 
study or withdraw from the study at any time during the course of the study. You will not be 
discriminated against or retaliated against for refusing to participate in the study. Your 
medical treatment and entitlements will not be affected. 
Your doctor or researcher may suspend your participation at any time in the best 
interest of you 
If you withdraw from the study for any reason, you may also be required to undergo 
a laboratory and physical examination if your doctor deems it necessary. 
If you choose to participate in this study, we hope that you can adhere to the 
completion of the entire research process 
11. Others 
Participating in this study is up to you. You can discuss it with your family or friends 
before making a decision. 
Before you decide to participate in the study, ask your doctor as many questions as 
you can about the study until you have a complete understanding of it. 
Thank you for reading this. If you decide to participate in the study, please tell your 
doctor, he or she will arrange for you to participate in all matters related to the study. 
Please keep this information 
 
 

EndoAngel Study 
Versio 1.0/May 18,2021 
Informed Consent Form: Information page 
Name of Clinical Research Project:Study on the effectiveness of artificial 
intelligence assistant system in improving the training effect of advanced physicians' 
enteroscopy. 
Research physician commitment: 
As a research physician, I confirmed that I had clearly explained to the 
subject the details of this trial, including their rights and possible benefits and 
risks, and gave them a signed copy of my informed consent. 
Name：＿＿＿＿＿＿＿ 
Date: ＿＿＿＿＿＿ 
Contact：＿＿＿＿＿＿＿ 
Subject commitment: 
I have read and understood the introduction to this study on the informed 
consent page, and have had the opportunity to ask questions. I understand the 
research physician's explanation. 
I am aware of the risks and benefits of participating in this study. I am aware 
that participation in the study is voluntary, and I am sure that there has sufficient 
time to consider and volunteer for the trial. I can always ask my doctor for more 
information, and I can always withdraw from the study without discrimination or 
retaliation, and without prejudice to medical benefits and entitlements. 
I also knew that if I dropped out of the study, I would tell my doctor and 
complete the physical and chemical tests. If I need to take any other medication 
for my illness, I will consult with my doctor in advance or tell him the truth 
afterwards. 
I agree□ or refuse□ Use my medical records for any other study. 
I agree to participate in the study and promised to follow the doctor's advice 
to the best of my ability. I will receive a signed and dated copy of the Informed 
Consent Form. 
Name：＿＿＿＿＿＿＿ 
Date: ＿＿＿＿＿＿＿ 
Contact：＿＿＿＿＿＿＿