Clinical Trial of Efficacy and Safety of Fengh Disposable Powered Articulating Endoscopic Linear Cutter Stapler Used for Gastrointestinal Tissue Cutting and Anastomosis
Phase: NA
Conditions: Gastrointestinal Neoplasm
Sponsor: Fengh Medical Co., Ltd.

Protocol No.: 20256031708
Clinical Trial on Performance and Safety of
Disposable Powered Articulating Endoscopic Linear
Cutter Stapler in Gastrointestinal Tissue Cutting and
Anastomosis
(Prospective, multi-center, stratified block randomization, incomplete blinding, parallel positive
control, non-inferiority testing)
Study Device: Disposable Powered Articulating Endoscopic Linear
Cutter Stapler
Product Specifications: See the IFU for details.
Regulatory Category of Study Medical Device: Class III medical
device
Requiring Clinical Trial Review and Approval: YesNo
Similar Product(s) Existing in China: YesNo
Protocol Version No.: 1.1
Protocol Version Date: 2019.01.25
Leading Site: Yangzhou First People's Hospital
Coordinating Investigator: Ni Qing
Sponsor: Fengh Medical Co., Ltd.
Agent :/
Confidentiality Statement
All information contained in this report is proprietary to Fengh Medical Co., Ltd. Therefore, it
is only provided to the investigators, co-investigators, ethics committees, regulatory
authorities and other relevant medical institutions for review. Without the written approval of
the sponsor, no information should be given to any third party not involved in the study,
except for necessary explanation when signing the informed consent form with the subjects
who may participate in the study.

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Notes:
1. To carry out clinical trials of medical devices, clinical trial protocols
shall be developed.
2. The clinical trial protocol is jointly designed and developed by the
investigators of the clinical study institution and the sponsor. The sponsor
shall sign the clinical trial protocol approved by both parties, and clinical
study agreement or contract with the clinical study institutions and
investigators.
3. The clinical trial protocol shall be approved by the ethics committee of
this institution.
4. The clinical study of investigational medical devices listed in the
Catalogue of Class III Medical Devices Requiring Clinical Trial Review
and Approval shall not be implemented until approved by NMPA.
5. Clinical trial institutions and investigators shall jointly formulate the
case number and duration of clinical study for each disease according to
clinical statistical methods, characteristics of investigational medical
devices, existing data and evidence with the sponsor, thereby ensuring to
achieve the intended purpose of the study and reduce the waste of
resources.
6. For a multi-center clinical trial, only the leading site should be filled in
for the "clinical study institution" on the cover, and other institutions
should be listed in the protocol.
7. For a multi-center clinical trial, the coordinating investigator shall be
filled in for the "investigator" on the cover.

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Content
Abstract of Trial Protocol.............................................................................................. 1
Trial Flow Chart.............................................................................................................6
List of Abbreviations..................................................................................................... 7
Text of Study Protocol................................................................................................... 8
1. Sponsor Information.................................................................................................. 8
1.1 Sponsor Name..................................................................................................8
1.2 Sponsor Address.............................................................................................. 8
1.3 Sponsor Contact...............................................................................................8
1.4 Sponsor-Related Qualification Documents......................................................8
2. List of All Clinical Trial Institutions and Investigators in Multi-Center Clinical Trial8
3. Purpose and Content of Clinical Trial........................................................................9
3.1 Purpose.............................................................................................................9
3.2 Content.............................................................................................................9
4. Background Data of Clinical Trial.............................................................................9
5. Product Model, Structural Composition, Operating Principle, Mechanism of Action
and Trial Scope............................................................................................................ 10
5.1 Product Model/Specification......................................................................... 10
5.2 Product Structural Composition.....................................................................14
5.3 Product Performance......................................................................................14
5.4 Trial Scope.....................................................................................................14
6. Product Applicable Scope, Contraindications and Precautions...............................15
6.1 Applicable Scope........................................................................................... 15
6.2 Contraindications...........................................................................................15
6.3 Cautions......................................................................................................... 15
6.4 Precautions.....................................................................................................15
6.5 Application Method....................................................................................... 15
7. Reference Medical Device-Related Information..................................................... 15
7.1 Stapler Information........................................................................................15
7.2 Reload Information........................................................................................16
8. Overall Design......................................................................................................... 17
8.1 Test Design.....................................................................................................17
8.2 Test Process....................................................................................................30
8.3 Monitoring Plan.............................................................................................36

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9. Statistical Considerations.........................................................................................37
9.1 Statistical Design, Methods and Analysis Procedure.....................................37
9.2 Sample Size Calculation................................................................................ 37
9.3 Significance Level and Power of Clinical Trial.............................................38
9.4 Expected Dropout Rate..................................................................................38
9.5 Qualification/Disqualification Criteria for Clinical Trial Results..................38
9.6 Criteria and Reasons for Terminating Trial Based on Statistical Reasons.....39
9.7 Statistical Methods of Data, Together with Processing Methods of Missing,
Unused or Wrong Data and Unreasonable Data.................................................. 39
9.8 Procedures for Reporting Deviations from Original Statistical Plan.............40
9.9 Selection Criteria and Reasons for Subjects Included in Analysis................ 40
9.10 Exclusion of Special Information During Hypothesis Validation and
Reasons................................................................................................................ 40
10. Data Management..................................................................................................40
10.1 Database Design.......................................................................................... 40
10.2 Data Receipt and Data Entry....................................................................... 41
10.3 Management of Data Verification and Query..............................................41
10.4 Database Lock and Data Archiving............................................................. 41
11. Feasibility Analysis................................................................................................42
11.1 Probability Analysis of Success...................................................................42
11.2 Probability Analysis of Failure.................................................................... 42
11.3 Conclusion................................................................................................... 42
12. Quality Control of Clinical Trial............................................................................42
12.1 Quality Assurance........................................................................................42
12.2 Quality Control............................................................................................ 43
13. Ethical Issues and Informed Consent of Clinical Trial..........................................44
13.1 Ethical Considerations................................................................................. 44
13.2 Approval of Study Protocol......................................................................... 45
13.3 Informed Consent Process and Informed Consent Form Text.....................45
13.4 Personal Data and Data Protection.............................................................. 46
14. Provisions for Reporting Adverse Events and Device Defects..............................46
14.1 Adverse Event..............................................................................................46
14.2 Serious Adverse Event.................................................................................48

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14.3 Reporting and Handling of Device Defects.................................................49
15. Device Management.............................................................................................. 49
15.1 Study Device Management..........................................................................49
15.2 Device Packaging........................................................................................ 49
15.3 Recovery of Remaining Device...................................................................49
16. Deviations from Clinical Trial Protocol and Provision for Amendments to Clinical
Trial Protocol............................................................................................................... 49
16.1 Deviations from Clinical Trial Protocol.......................................................49
16.2 Amendments to Clinical Trial Protocol....................................................... 51
17. Direct Accessed Source Data/Source Documents................................................. 51
18. Finance and Insurance........................................................................................... 51
19. Contents Covered in Clinical Trial Report............................................................ 52
20. Confidentiality....................................................................................................... 52
21. Agreement on Publication of Study Results.......................................................... 53
22. Responsibilities Assumed by Each Party...............................................................53
22.1 Responsibilities of Sponsor......................................................................... 53
22.2 Responsibilities of Clinical Trial Institution and Investigators................... 54
23. References..............................................................................................................56
24. Supplementary Provisions..................................................................................... 57
Investigator Statement................................................................................................. 60

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Abstract of Trial Protocol
Trial Name
Clinical Trial on Performance and Safety of Disposable Powered Articulating
Endoscopic Linear Cutter Stapler in Gastrointestinal Tissue Cutting and
Anastomosis
Sponsor
Fengh Medical Co., Ltd.
Device Name
Study/investigational device: Disposable Powered Articulating Endoscopic
Linear Cutter Stapler
Control device: ECHELON Flex Powered Articulating Endoscopic Linear
Cutters
Regulatory Category
Class III medical device
Trial Scope
The trial is intended for patients to be subject to gastrointestinal tissue cutting and
anastomosis
Clinical Trial
Indication
Gastrointestinal tissue cutting and anastomosis
Trial Design
Prospective, multi-center, stratified block randomization, incomplete blinding,
parallel positive control, non-inferiority testing
Trial Purpose
By comparing the effectiveness and safety of Disposable Powered Articulating
Endoscopic Linear Cutter Stapler (product under application) manufactured by
Fengh Company with the similar product (ECHELON Flex Powered Articulating
Endoscopic Linear Cutters manufactured by Johnson & Johnson Company) in
gastrointestinal tissue cutting and anastomosis, it is demonstrated that the product
under application can be used for anastomosis of digestive tract, and the clinical
trial meets the requirements of Good Clinical Practice for Medical Devices and
Guidelines for Technical Review of Endoscopic Stapler Registration, which can
be used for product registration application.
Sample Size
164 cases, randomly divided into the test group and the control group, with 82
cases in both the test group and control group, respectively
Center Number
5
Follow-up period:
37 days
Test Time
(1) Enrollment date of the first subject: June 2018
(2) Duration of subject recruitment: 6 months
(3) Completion date of the last subject: December 2018
Primary Effectiveness
(1) Success rate of anastomosis

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Evaluation Indicator
Secondary
Effectiveness
Evaluation Indicator
(1) Conversion rate due to stapler-related causes
(2) Number of stitches for anastomotic repair
(3) Operation time
(4) Anastomosis time
(5) Anastomotic healing time
(6) First flatus time
(7) First bowel movement time
(8) Semi-liquid diet time
Safety Evaluation
Indicator
(1) Incidence of anastomotic dehiscence
(2) Incidence of anastomotic bleeding
(3) Incidence of anastomotic leakage
(4) Incidence of anastomotic stricture
(5) Incidence of anastomotic infection
(6) Incidence of SAEs
(7) Incidence of AEs
Operational
Performance
Evaluation
(1) Stapler operational performance evaluation
Inclusion Criteria
(1) Subjects aged 18-75 years old, male or female;
(2) Subjects who are intended to undergo gastrointestinal tissue cutting and
anastomosis with linear stapler;
(3) Subjects or their guardians are able to understand the purpose of the study,
show adequate compliance with the trial protocol, and sign an informed
consent.
Exclusion Criteria
(1) Subjects who are scheduled to receive gastrointestinal emergency surgery;
(2) Subjects with moderate malnutrition (BMI < 17 kg/m2) and severe anemia
(Hb < 60 g/L);
(3) Subjects with a BMI ≥28 kg/m2;
(4) Subjects who have a platelet (PLT) < 60 × 10 9/L or international normalized
ratio (INR) > 1.5;
(5) Subjects with forced expiratory volume in one second (FEV1)/predicted
value ≤50%, or forced expiratory volume in one second (FEV1)/forced vital

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capacity (FCV) ≤60%;
(6) Subjects with ejection fraction ≤50%;
(7) Subjects with important organ failure or other serious diseases (e.g., the
subject's aspartate aminotransferase (AST), alanine aminotransferase (ALT),
or serum creatinine (Scr) is more than 3 times of the upper limit of normal
before surgery; the subject's fasting blood glucose value before surgery is ≥
10.0 mmol/L);
(8) Subjects who are pregnant or lactating women;
(9) Subject who have participated in other drug or device clinical trials within 3
months prior to the trial;
(10)Other situations not suitable for inclusion judged by investigators.
Device Usage
Specification
According to the results of random allocation, the investigators apply the
investigational medical device to the subjects who enter the test group, and the
control medical device to the subjects who enter the control group. If a subject
required the use of a circular stapler during the trial, the brand and model of the
circular stapler are required to be recorded.
Concomitant
medication/concomitant
treatment
If a subject receives any medication or treatment for an adverse event
during the study for any reason, the investigators are required to record
such occurrence on the case report form (CRF) for easy access.
Inspection Items
Medical history and vital signs, etc.:
(1) Demographic data: gender, date of birth;
(2) History of present illness: admission time, etiology;
(3) Past medical history: history of allergy, dysfunction of vital organs (heart,
lung, liver and kidney), surgery and previous medication history (within 1
month);
(4) Vital signs: height, weight, blood pressure, pulse, body temperature,
respiration, BMI;
Laboratory examinations:
(1) Blood routine: hemoglobin (Hgb), red blood cell count (RBC), white blood
cell count (WBC), neutrophil count (NEUT), neutrophil ratio (NEUT%),
platelet count (PLT);
(2) Coagulation blood routine: prothrombin time (PT), activated partial
thromboplastin time (APTT), international normalized ratio (INR);

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(3) Blood biochemistry: aspartate aminotransferase (AST), alanine
aminotransferase (ALT), serum total bilirubin (STB), serum albumin (ALB),
serum creatinine (Scr), blood urea nitrogen (BUN);
(4) Fasting blood glucose;
(5) Fecal examination: occult blood test;
(6) Cardiac ultrasonography: cardiac ejection fraction;
(7) Pulmonary function test: forced expiratory volume in one second
(FEV1)/predicted value, forced expiratory volume in one second
(FEV1)/forced vital capacity (FCV);
(8) Blood pregnancy test: applicable for women of childbearing age (18-50 years
old).
Preoperative imaging:
(1) CT examination: tumor stage, whether there is liver metastasis, whether there
is pelvic metastasis, whether there is lung metastasis;
Post-operative imaging:
(1) Angiography: whether there is anastomotic bleeding;
(2) Upper gastrointestinal radiography: whether there is anastomotic leakage and
stricture;
(3) Gastrointestinal endoscopic examination: whether there is anastomotic
leakage and stricture;
(4) Abdominal CT: whether there is abdominal effusion and the amount of
abdominal effusion;
Other tests:
(1) Intraoperative observation items: name of operation, start time of operation,
end time of operation, start time of anastomosis, end time of anastomosis and
intraoperative blood loss;
(2) Observation of the study product: whether the digestive tract is successfully
transected and stapled, whether the cutting anastomosis ring/staple line is
complete, whether there is leakage of cutting anastomosis ring/staple line,
whether there is bleeding of cutting anastomosis ring/staple line, whether
there is bubble overflow at the anastomotic stoma, whether there are
indicators of conversion to laparotomy, number of needles for anastomotic
repair, whether there is anastomotic dehiscence, whether there are other

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complications, whether the staple line or tissue buttressing materials are
used, and the operating performance of stapler;
(3) Device use: model and specification of electric stapler, model of cartridge,
use condition, cutting and stapling tissues, device defects;
(4) Postoperative follow-up observation: first anus exhaust time, semi-liquid
feeding time, first defecation time, bowel sound recovery time, whether there
is anastomotic bleeding, whether there is anastomotic leakage, whether there
is anastomotic stenosis, whether there are other complications, whether there
is abdominal effusion and the abdominal effusion volume;
(5) Routine observation items: adverse events, concomitant medication, protocol
deviations.
Statistical Analysis
Statistical analysis is performed using SAS 9.1 software.
Perform statistical description on all data, including demographic data, baseline
data, all efficacy indicators and all safety data. Measurement data include the
mean, standard deviation, minimum, maximum, median, 25th percentile and 75th
percentile; enumeration data include frequency and corresponding percentage.
The primary effectiveness evaluation indicators are evaluated using the
confidence interval method.
For secondary evaluation indicators, the difference test is adopted. Two
independent samples t test is adopted for measurement data.
Difference test is used for safety evaluation indicators. Two independent samples
t test is used for measurement data. Pearson X2 test or Fisher's exact test is used
for enumeration data. The adverse events and device defects occurred in this trial
are described in list.
Difference test is used to evaluate the operating performance of the stapler.
Pearson X2 test or Fisher exact test is used to analyze enumeration data.
Center effect is considered during the analysis process. General linear model is
used for measurement data. CMH is used for enumeration data.

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Trial Flow Chart
Visit Time
Visit Item
Visit 1
Visit 2
Visit 3
Visit 4
Before surgery
(Day -7 ~ 0)
During surgery
(Day 0)
After surgery
(Day 7 ± 2 days)
After surgery
(Day 30 ± 5 days)
Informed consent
▲
Subject screening
▲
Demographic data
▲
History of present illness
▲
Past medical history
▲
Vital signs
▲
▲
▲
▲
Blood routine
▲
▲
Coagulation routine
▲
▲
Blood biochemistry
▲
▲
Cardiac examination
▲
▲
▲
Pulmonary function test
▲
Arterial blood gas
analysis
▲
Preoperative imaging
▲
Blood pregnancy test
▲
Randomization
▲
Intraoperative
observation record
▲
Use of device
▲
Postoperative imaging
▲
Postoperative follow-up
observation
▲
▲
Concomitant medication
▲
▲
▲
▲
Adverse events
▲
▲
▲
▲
Device defect
▲

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List of Abbreviations
Abbreviation
English
Chinese
AE
Adverse Events
不良事件
CRF
Case Report Form
病例报告表
EC
Ethics Committee
伦理委员会
FAS
Full Analysis Set
全分析集
GCP
Good Clinical Practice
医疗器械临床试验质量管理规范
ICF
Informed Consent Form
知情同意书
PPS
Per-Protocol Set
符合方案集
SAE
Serious Adverse Events
严重不良事件
SOP
Standard Operating Procedure
标准操作规程
SS
Safety Set
安全数据集

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Text of Study Protocol
1. Sponsor Information
1.1 Sponsor Name
Fengh Medical Co., Ltd.
1.2 Sponsor Address
Address/production address: D3 No. 6 Dongsheng West Road, Jiangyin National High-tech Zone, 214437
Jiangsu, P.R. China
1.3 Sponsor Contact
Contact PersonLiu Jiao
Tel
(86) 510-81695550
Mobile
13815132106
Fax
(86) 510-81695550
E-mail
liuj_fenghmedical@163.com
1.4 Sponsor-Related Qualification Documents
Social credit code 91320281583765063L
Registration
inspection report
2017ZC2908, 2017ZC2908-EMC, 2017QW0247
2. List of All Clinical Trial Institutions and Investigators in Multi-Center Clinical Trial
Code
number
Name of clinical trial
institution
Investigator
Title
Contact information
01
Yangzhou
First
People's
Hospital
Ni Qing
Chief
Physician
Tel: 13951056866
E-mail: yzniqing@163.com
02
Affiliated
Hospital
of
Jiangsu University
Sanrong Xu
Chief
Physician
Phone: 13775531799
E-mail: zjxsrong@163.com
03
Quzhou People's Hospital
Mao
Xinglong
Chief
Physician
Tel: 13757055369
E-mail: qzryjgb@126.com
04
Lishui Central Hospital
Hongtao Xu
Chief
Physician
Tel: 15024622762
E-mail: xht0071@sina.com
05
Shanghai
Tongren
Hospital
Sun Peng
Chief
Physician
Tel: 18121225835
E-mail: sp2082@shtrhospital.com

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3. Purpose and Content of Clinical Trial
3.1 Purpose
By comparing the effectiveness and safety of Disposable Powered Articulating Endoscopic Linear Cutter
Stapler (product under application) produced by Fengh Company with the similar product (ECHELON Flex
Powered Articulating Endoscopic Linear Cutters manufactured by Johnson & Johnson Company) in
gastrointestinal tissue cutting and anastomosis, it is proved that the product under application can be used for
alimentary tract anastomosis, and the clinical trial meets the requirements of Good Clinical Practice for
Medical Devices and Guidelines for Technical Review of Endoscopic Stapler Registration, which can be used
for product registration application.
3.2 Content
This clinical trial is a prospective study. The patients scheduled for gastrointestinal tissue cutting and
anastomosis were selected as the study subjects. The subjects were randomly divided into the test group and
control group. Subjects in the test group received the Disposable Powered Articulating Endoscopic Linear
Cutter Stapler manufactured by Fengh Company, and the subjects in the control group received the similar
product (ECHELON Flex Powered Articulating Endoscopic Linear Cutters) manufactured by Johnson &
Johnson Company. The subjects were blinded and were followed up for 4 visits within 1 month. The
collected data were analyzed and compared to evaluate the effectiveness and safety of the Disposable
Powered Articulating Endoscopic Linear Cutter Stapler manufactured by Fengh Company in gastrointestinal
tissue cutting and anastomosis.
4. Background Data of Clinical Trial
Since laparoscopic surgery is increasingly and widely used in the treatment of gastric cancer, the stapler
cooperating with laparoscopic surgery is also widely used in clinical practice. Stapler is an alternative manual
suture device used in medicine. Its main operating principle is to use titanium nail for transection or
anastomosis of tissues, which is similar to book stapler. According to different applicable scopes, it can be
divided into skin stapler, linear stapler, circular stapler, circular hemorrhoidal stapler, circumcision stapler,
vascular stapler, hernia stapler, etc.
Compared with the traditional manual suture, the advantages of anastomosis suture include: ①simple and
convenient operation, saving operation time; ②disposable use, avoiding cross-infection; ③tight and
moderate suture using titanium nail or stainless steel nail (skin stapler); ④few side effects and effectively
reducing surgical complications.
In order to provide clinicians with a more convenient thoracoscopic linear stapler, Fengh Company develops
one kind of Disposable Powered Articulating Endoscopic Linear Cutter Stapler according to market demands.

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This linear stapler is driven by electric motor, which can better reduce the surgical intensity of doctors and
save surgical time.
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler designed and developed by Fengh
Company according to the clinical treatment characteristics have passed the test by Jiangsu Institute for
Medical Device Testing of NMPA (original CFDA) [2017ZC2908, 2017ZC2908-EMC, 2017QW0247].
This clinical trial is to test the safety and effectiveness of the device by evaluating the success rate of
anastomosis of the device after use, so as to provide trial basis for the product registration.
5. Product Model, Structural Composition, Operating Principle, Mechanism of Action
and Trial Scope
5.1 Product Model/Specification
Table 1 Model and specification of Electric stapler
Model/specification of electric
stapler
Arm length (L3)
Length of
reload-resisting base
(L1)
Overall length (L)
FSMS30
192 ± 20
66.3 ± 2.5
538.6 ± 20
FSMS45
192 ± 20
78.3 ± 2.5
547.6 ± 20
FSMS60
192 ± 20
90.3 ± 2.5
562.6 ± 20
FSMM30
252 ± 20
66.3 ± 2.5
538.6 ± 20
FSMM45
252 ± 20
78.3 ± 2.5
547.6 ± 20
FSMM60
252 ± 20
90.3 ± 2.5
562.6 ± 20
FSML30
352 ± 20
66.3 ± 2.5
538.6 ± 20
FSML45
352 ± 20
78.3 ± 2.5
547.6 ± 20
FSML60
352 ± 20
90.3 ± 2.5
562.6 ± 20
FSAS30
192 ± 20
66.3 ± 2.5
538.6 ± 20
FSAS45
192 ± 20
78.3 ± 2.5
547.6 ± 20
FSAS60
192 ± 20
90.3 ± 2.5
562.6 ± 20
FSAM30
252 ± 20
66.3 ± 2.5
538.6 ± 20
FSAM45
252 ± 20
78.3 ± 2.5
547.6 ± 20
FSAM60
252 ± 20
90.3 ± 2.5
562.6 ± 20
FSAL30
352 ± 20
66.3 ± 2.5
538.6 ± 20
FSAL45
352 ± 20
78.3 ± 2.5
547.6 ± 20
FSAL60
352 ± 20
90.3 ± 2.5
562.6 ± 20
FNMS30
192 ± 20
66.3 ± 2.5
538.6 ± 20
FNMS45
192 ± 20
78.3 ± 2.5
547.6 ± 20
FNMS60
192 ± 20
90.3 ± 2.5
562.6 ± 20
FNMM30
252 ± 20
66.3 ± 2.5
538.6 ± 20
FNMM45
252 ± 20
78.3 ± 2.5
547.6 ± 20
FNMM60
252 ± 20
90.3 ± 2.5
562.6 ± 20
FNML30
352 ± 20
66.3 ± 2.5
538.6 ± 20
FNML45
352 ± 20
78.3 ± 2.5
547.6 ± 20
FNML60
352 ± 20
90.3 ± 2.5
562.6 ± 20
FNAS30
192 ± 20
66.3 ± 2.5
538.6 ± 20
FNAS45
192 ± 20
78.3 ± 2.5
547.6 ± 20
FNAS60
192 ± 20
90.3 ± 2.5
562.6 ± 20
FNAM30
252 ± 20
66.3 ± 2.5
538.6 ± 20
FNAM45
252 ± 20
78.3 ± 2.5
547.6 ± 20

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Model/specification of electric
stapler
Arm length (L3)
Length of
reload-resisting base
(L1)
Overall length (L)
FNAM60
252 ± 20
90.3 ± 2.5
562.6 ± 20
FNAL30
352 ± 20
66.3 ± 2.5
538.6 ± 20
FNAL45
352 ± 20
78.3 ± 2.5
547.6 ± 20
FNAL60
352 ± 20
90.3 ± 2.5
562.6 ± 20
DSMS30
192 ± 20
66.3 ± 2.5
538.6 ± 20
DSMS45
192 ± 20
78.3 ± 2.5
547.6 ± 20
DSMS60
192 ± 20
90.3 ± 2.5
562.6 ± 20
DSMM30
252 ± 20
66.3 ± 2.5
538.6 ± 20
DSMM45
252 ± 20
78.3 ± 2.5
547.6 ± 20
DSMM60
252 ± 20
90.3 ± 2.5
562.6 ± 20
DSML30
352 ± 20
66.3 ± 2.5
538.6 ± 20
DSML45
352 ± 20
78.3 ± 2.5
547.6 ± 20
DSML60
352 ± 20
90.3 ± 2.5
562.6 ± 20
DSAS30
192 ± 20
66.3 ± 2.5
538.6 ± 20
DSAS45
192 ± 20
78.3 ± 2.5
547.6 ± 20
DSAS60
192 ± 20
90.3 ± 2.5
562.6 ± 20
DSAM30
252 ± 20
66.3 ± 2.5
538.6 ± 20
DSAM45
252 ± 20
78.3 ± 2.5
547.6 ± 20
DSAM60
252 ± 20
90.3 ± 2.5
562.6 ± 20
DSAL30
352 ± 20
66.3 ± 2.5
538.6 ± 20
DSAL45
352 ± 20
78.3 ± 2.5
547.6 ± 20
DSAL60
352 ± 20
90.3 ± 2.5
562.6 ± 20
DNMS30
192 ± 20
66.3 ± 2.5
538.6 ± 20
DNMS45
192 ± 20
78.3 ± 2.5
547.6 ± 20
DNMS60
192 ± 20
90.3 ± 2.5
562.6 ± 20
DNMM30
252 ± 20
66.3 ± 2.5
538.6 ± 20
DNMM45
252 ± 20
78.3 ± 2.5
547.6 ± 20
DNMM60
252 ± 20
90.3 ± 2.5
562.6 ± 20
DNML30
352 ± 20
66.3 ± 2.5
538.6 ± 20
DNML45
352 ± 20
78.3 ± 2.5
547.6 ± 20
DNML60
352 ± 20
90.3 ± 2.5
562.6 ± 20
DNAS30
192 ± 20
66.3 ± 2.5
538.6 ± 20
DNAS45
192 ± 20
78.3 ± 2.5
547.6 ± 20
DNAS60
192 ± 20
90.3 ± 2.5
562.6 ± 20
DNAM30
252 ± 20
66.3 ± 2.5
538.6 ± 20
DNAM45
252 ± 20
78.3 ± 2.5
547.6 ± 20
DNAM60
252 ± 20
90.3 ± 2.5
562.6 ± 20
DNAL30
352 ± 20
66.3 ± 2.5
538.6 ± 20
DNAL45
352 ± 20
78.3 ± 2.5
547.6 ± 20
DNAL60
352 ± 20
90.3 ± 2.5
562.6 ± 20
Table 2 Model and specification of cartridge components
Unit: mm
Model/specification of reload
Reload color
Reload number
Anastomosis length (L2)
FMCC30
Gray
36
35.2 ± 2
FMCC45
Gray
70
49.3 ± 2
FMCC60
Gray
88
61.3 ± 2

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Model/specification of reload
Reload color
Reload number
Anastomosis length (L2)
FMCW30
White
36
35.2 ± 2
FMCW45
White
70
49.3 ± 2
FMCW60
White
88
61.3 ± 2
FMCT30
Brown
36
35.2 ± 2
FMCT45
Brown
70
49.3 ± 2
FMCT60
Brown
88
61.3 ± 2
FMCB30
Blue
36
35.2 ± 2
FMCB45
Blue
70
49.3 ± 2
FMCB60
Blue
88
61.3 ± 2
FMCG30
Green
36
35.2 ± 2
FMCG45
Green
70
49.3 ± 2
FMCG60
Green
88
61.3 ± 2
FMCP30
Purple
36
35.2 ± 2
FMCP45
Purple
70
49.3 ± 2
FMCP60
Purple
88
61.3 ± 2
FMCY30
Gold
36
35.2 ± 2
FMCY45
Gold
70
49.3 ± 2
FMCY60
Gold
88
61.3 ± 2
FMCX30
Black
36
35.2 ± 2
FMCX45
Black
70
49.3 ± 2
FMCX60
Black
88
61.3 ± 2
FACC30
Gray
36
35.2 ± 2
FACC45
Gray
70
49.3 ± 2
FACC60
Gray
88
61.3 ± 2
FACW30
White
36
35.2 ± 2
FACW45
White
70
49.3 ± 2
FACW60
White
88
61.3 ± 2
FACT30
Brown
36
35.2 ± 2
FACT45
Brown
70
49.3 ± 2
FACT60
Brown
88
61.3 ± 2
FACB30
Blue
36
35.2 ± 2
FACB45
Blue
70
49.3 ± 2
FACB60
Blue
88
61.3 ± 2
FACG30
Green
36
35.2 ± 2
FACG45
Green
70
49.3 ± 2

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Model/specification of reload
Reload color
Reload number
Anastomosis length (L2)
FACG60
Green
88
61.3 ± 2
FACP30
Purple
36
35.2 ± 2
FACP45
Purple
70
49.3 ± 2
FACP60
Purple
88
61.3 ± 2
FACY30
Gold
36
35.2 ± 2
FACY45
Gold
70
49.3 ± 2
FACY60
Gold
88
61.3 ± 2
FACX30
Black
36
35.2 ± 2
FACX45
Black
70
49.3 ± 2
FACX60
Black
88
61.3 ± 2
DMCC30
Gray
36
35.2 ± 2
DMCC45
Gray
70
49.3 ± 2
DMCC60
Gray
88
61.3 ± 2
DMCW30
White
36
35.2 ± 2
DMCW45
White
70
49.3 ± 2
DMCW60
White
88
61.3 ± 2
DMCT30
Brown
36
35.2 ± 2
DMCT45
Brown
70
49.3 ± 2
DMCT60
Brown
88
61.3 ± 2
DMCB30
Blue
36
35.2 ± 2
DMCB45
Blue
70
49.3 ± 2
DMCB60
Blue
88
61.3 ± 2
DMCG30
Green
36
35.2 ± 2
DMCG45
Green
70
49.3 ± 2
DMCG60
Green
88
61.3 ± 2
DMCP30
Purple
36
35.2 ± 2
DMCP45
Purple
70
49.3 ± 2
DMCP60
Purple
88
61.3 ± 2
DMCY30
Gold
36
35.2 ± 2
DMCY45
Gold
70
49.3 ± 2
DMCY60
Gold
88
61.3 ± 2
DMCX30
Black
36
35.2 ± 2
DMCX45
Black
70
49.3 ± 2
DMCX60
Black
88
61.3 ± 2
DACC30
Gray
36
35.2 ± 2

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Model/specification of reload
Reload color
Reload number
Anastomosis length (L2)
DACC45
Gray
70
49.3 ± 2
DACC60
Gray
88
61.3 ± 2
DACW30
White
36
35.2 ± 2
DACW45
White
70
49.3 ± 2
DACW60
White
88
61.3 ± 2
DACT30
Brown
36
35.2 ± 2
DACT45
Brown
70
49.3 ± 2
DACT60
Brown
88
61.3 ± 2
DACB30
Blue
36
35.2 ± 2
DACB45
Blue
70
49.3 ± 2
DACB60
Blue
88
61.3 ± 2
DACG30
Green
36
35.2 ± 2
DACG45
Green
70
49.3 ± 2
DACG60
Green
88
61.3 ± 2
DACP30
Purple
36
35.2 ± 2
DACP45
Purple
70
49.3 ± 2
DACP60
Purple
88
61.3 ± 2
DACY30
Gold
36
35.2 ± 2
DACY45
Gold
70
49.3 ± 2
DACY60
Gold
88
61.3 ± 2
DACX30
Black
36
35.2 ± 2
DACX45
Black
70
49.3 ± 2
DACX60
Black
88
61.3 ± 2
5.2 Product Structural Composition

Electric stapler consists of stapler body, arm rod, reload-resisting base, reload base, battery pack or
power adapter.

The cartridge component is composed of reload, reload-pushing piece and anastomotic nail, etc.
5.3 Product Performance
The main technical indicators of electric stapler include convenient replacement of stapler components,
reliable positioning. In addition, the stapler is equipped with a safety protection device for empty staple
cartridge to maintain its reliability. The product shall be sterile.
5.4 Trial Scope
The product is intended for patients planning to receive gastrointestinal tissue cutting and anastomosis.

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6. Product Applicable Scope, Contraindications and Precautions
6.1 Applicable Scope
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler is intended for transection, resection,
and/or creation of anastomoses. The instrument has application in multiple open or minimally invasive
general, gynecologic, urologic, thoracic, and pediatric surgical procedures. It can be used with staple line or
tissue buttressing materials. The instrument may also be used for transection and resection of liver
parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
6.2 Contraindications

Do not use the instruments on the aorta.

Do not use the instruments on ischemic or necrotic tissue.

Do not use any linear cutter on major vessels without making provision for proximal and distal control.

Tissue thickness should be carefully evaluated before firing any stapler. Refer to Reload Product Codes
for tissue compression requirement (closed staple height) for each staple size. If tissue cannot
comfortably compress to the closed stale height, or easily compresses to less than the closed staple height,
the tissue is contraindicated as it may be too thick or too thin for the selected staple size.
These instruments are not intended for use when surgical stapling is contraindicated.
6.3 Cautions
See the IFU for details.
6.4 Precautions
See the IFU for details.
6.5 Application Method
See the IFU for details.
7. Reference Medical Device-Related Information
7.1 Stapler Information
Product name
ECHELON Flex Powered Articulating Endoscopic Linear Cutters
Specification/modelPSE45A, PCE45A, PLE45A, PSE60A, PCE60A, PLE60A
Registration No.
GXZJ 20173226240
Structural
The product is a sterile device for single patient use, consisting of closing rod, red firing
lock, firing handle, anvil release button, lithium battery pack, battery pack-releasing
piece, hole cover plate for manual override maintenance, knife-reversing switch, knob,

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composition
articulation fins, reload alignment slot, anvil jaw and reload jaw. The lithium battery
pack must be installed prior to use. The product has been sterilized by irradiation. This
product is provided for single use.
Applicable scope
The Disposable Powered Articulating Endoscopic Linear Cutter Stapler is intended for
transection, resection, and/or creation of anastomoses. The instrument has application in
multiple open or minimally invasive general, gynecologic, urologic, thoracic, and
pediatric surgical procedures. It can be used with staple line or tissue buttressing
materials. The instrument may also be used for transection and resection of liver
parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Manufacturer
Ethicon Endo-Surgery, LLC
Agent
Johnson & Johnson Medical (Shanghai) Ltd.
7.2 Reload Information
Product name 1
echelon 60 ENDOPATH STAPLER Endoscopic Linear Cutter Reloads
Specification/model 1 ECR60W
Registration No. 1
GXZJ 20153080094
Structural
composition 1
The linear cutter stapler reload is composed of cartridge, anastomotic nail and
reload-protecting board, in which the material of anastomotic nail is Ti3Al2.5V. The
reload is sterilized by radiation and provided for single use.
Product name 2
ECHELON 45 ENDOPATH Stapler Endoscopic Linear Cutter and Reloads
Specification/model 2 ECR45M, EC45, SC45, ECLG45, ECR45W, ECR45B, ECR45D, ECR4 5G
Registration No. 2
GXZJ 20163654883
Structural
composition 2
The product is composed of anvil, trigger, firing trigger, handle and cartridge
component. The reload is sterilized by radiation and provided for single use.
Product name 3
ECHELON FLEX Articulating Linear Cutters and Reloads Articulating Endoscopic
Linear Cutter Reloads
Specification/model 3
EC45A, SC45A, EC45AL, EC60A, SC60A, LONG60A, ECR60W, ECR 60B,
ECR60D, ECR60G, ECR60T, ECR60M
Registration No. 3
GXZJ 20173656323

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Structural
composition 3
This product is composed of stapler and cartridge. Its components include cartridge,
closing rod, firing rod, rotary knob, articulating piece, manual knife-reversing switch,
trip count indicator, knife direction indicator, anvil release button, closing rod, and
anvil. The stapler is made of stainless steel, and the anastomotic needle is made of
titanium alloy (Tianium3A12.5V). The product is sterilized by radiation.
Applicable scope
It is used for transection, resection and/or anastomosis. It can be used in a variety of
open or minimally invasive general, gynecologic, urologic, thoracic, and pediatric
surgical procedures. It can be used with staple line or tissue buttressing materials.
These devices can also be used for transection and resection of liver parenchyma
tissues (hepatic vasculature and biliary structures), pancreas, kidney and spleen.
Manufacturer
Ethicon Endo-Surgery, LLC
Agent
Johnson & Johnson Medical (Shanghai) Ltd.
8. Overall Design
8.1 Test Design
8.1.1 Primary objective
To evaluate whether the primary effectiveness evaluation indicator "anastomosis success rate" of the
Disposable Powered Articulating Endoscopic Linear Cutter Stapler manufactured by Fengh Company is
non-inferior to the similar product manufactured by Johnson & Johnson Company in gastrointestinal tissue
cutting and anastomosis.
8.1.2 Secondary objectives
To evaluate whether there are differences in the secondary evaluation indicators when the Disposable
Powered Articulating Endoscopic Linear Cutter Stapler manufactured by Fengh Company is used in
gastrointestinal tissue cutting and anastomosis compared with the similar product manufactured by Johnson
& Johnson Company.
To evaluate whether there are differences in the safety evaluation indicators (e.g., incidence of AEs, incidence
of SAEs, incidence of device defects) between the Disposable Powered Articulating Endoscopic Linear
Cutter Stapler manufactured by Fengh Company and the similar product manufactured by Johnson &
Johnson Company in gastrointestinal tissue cutting and anastomosis.
8.1.3 Selection of test method and reasons
This clinical trial is a "prospective, multi-center, stratified-block randomization, incomplete blinding, parallel

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positive control, non-inferiority test".
(1) Prospective: A research method that tracks from the present to the future. Prospective studies can clarify
the causal relationship; uniform diagnostic, detection, and evaluation criteria can be available for the
obtained data, the data processing therefore is controllable.
(2) Multi-center: 5 clinical trial institutions were selected to conduct this clinical trial. The application of
multi-center trial can allow to obtain more cases than those of single-center trial in the same time, the
clinical trial time therefore can be shortened; since the multi-center trial is completed by different regions,
different trial centers and many clinical researchers, the conclusion therefore is often widely
representative.
(3) Stratified block randomization: This trial adopts the stratified block randomization method (with the
study site as the stratification factor) and the randomization envelope to randomize the subjects who are
screened successfully. The randomized-grouping time is when the subjects sign the ICF, which also
meets the inclusion and exclusion criteria in the protocol at the same time. Randomized grouping ensures
that, except for treatment factors, other non-treatment factors that may have confounding effect are kept
consistent in each group as far as possible, so as to ensure the balance of baseline of each group;
randomized-grouping allows each subject to have equal opportunity to be assigned to the test group or
control group.
(4) Incomplete blinding: Since the investigational medical device and the control medical device are
different in appearance, while the subjects are under anesthesia during the operation, the grouping
arrangement can not be known. Therefore, the method of incomplete blinding is used, that is, the
investigators knows the grouping result, while the subject does not know the grouping result. The
blinding method can minimize the bias caused by "placebo effect" and investigator bias; for the less
precise observation indicators, it can significantly reduce the bias; and make the evaluation of adverse
reactions by investigators and subjects more objective.
(5) Parallel positive control: The investigational medical device has the mature application technology with
many similar products that are marketed at home and abroad. It has been used in clinical practice for
many years, with exact effect and predictable occurrence of adverse events. Therefore, parallel positive
control is adopted in this clinical trial.
(6) Non-inferiority test: To evaluate whether the main effectiveness evaluation indicator "success rate of
anastomosis" of the Disposable Powered Articulating Endoscopic Linear Cutter Stapler manufactured by
Fengh Company is non-inferior to the similar product manufactured by Johnson & Johnson Company in
gastrointestinal tissue cutting and anastomosis. It is expected that the test product is similar to the control
product in performance. There is no significant difference in the expected results between the two groups

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in the primary efficacy indicator of "success rate of anastomosis" during gastrointestinal tissue cutting
and anastomosis. Therefore, the non-inferiority test is adopted.
8.1.4 Measures for reducing and avoiding bias
(1) Before the start of the study, the sponsor shall provide relevant training for the investigators participating
in the study to ensure that the investigators fully understand the study process and are familiar with the
operation of the study device; during the study, the investigators shall operate in strict accordance with
the operating methods and procedures in the study protocol, and the clinical trial monitor shall do a good
job in quality control and monitoring to ensure that the investigators operate and implement in strict
accordance with the study protocol. The above measures shall be implemented throughout the
implementation phase of the study to reduce errors or operational errors.
(2) Subjects shall be screened in strict accordance with the clinical diagnostic criteria, as well as the
inclusion and exclusion criteria of the trial protocol to reduce selection bias.
(3) Total laparoscopic digestive tract reconstruction is difficult to operate, which should be carried out in
centers with rich experience in laparoscopic surgery. In view of the learning curve of laparoscopic
surgery, doctors can be more proficient based on at least 50 cases[2]. The operating surgeon of
laparoscopic surgery is recommended to be experienced in at least 100 cases of open surgery as the
operator and 50 cases of laparoscopic surgery as the primary assistant.
(4) When the clinical trial is completed, the data storage and collation shall be done well. When data
problems are found, the data analyst shall check and confirm the data through the data clarification form
to avoid recording errors.
8.1.5 Investigational medical device and control medical device or control diagnosis and treatment
method
See the corresponding IFU for the diagnosis and treatment method with the investigational medical device
and the reference medical device. In addition, subjects may use circular stapler or other types of staplers
during the clinical trial. If these staplers are used, the investigators should truthfully record the model of these
staplers and staple cartridge for reference.
When subjects experience adverse events related to the stapler, the investigators should truthfully judge the
correlation between adverse events and the test device.
8.1.5.1 Information of circular stapler
Product name
ILS Curved and Straight Intraluminal Staplers
Specification/modelCDH21A, CDH25A, CDH29A, CDH33A, SDH21A, SDH25A, SDH29A, SDH33A

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Registration No.
GXZJ 20152652249
Manufacturer
Ethicon Endo-Surgery, LLC
Structural
composition
The product is composed of orange display area, trocar, reload, safety indicator window,
adjusting knob, safety device, firing trigger, staple board, anti-trocar, anti-trocar
protective cover, staple anvil head, knotting groove, locking spring leaf and staple anvil
rod. The material of stapler is medical stainless steel, the material of knob is
polycarboxylate, and the material of staple is titanium alloy. Radiation sterilization,
single use.
Scope
of
application
This product is used for end-to-end, end-to-side and side-to-side anastomosis of the
whole digestive tract.
Requirements
for
use
If the subjects in the test group or control group (only for the subjects at rectal site) need
to use the circular stapler during the clinical trial, the investigators shall uniformly use
the circular stapler (Johnson & Johnson brand, model CDH25A or CDH29A) uniformly
provided by Fengh Company. For the using process, records shall be truthfully kept for
reference.
8.1.6 Selection of Subjects
8.1.6.1 Clinical trial indications
At present, the Disposable Powered Articulating Endoscopic Linear Cutter Stapler can be used for "a variety
of open or minimally invasive surgeries in general surgery, obstetrics and gynecology, urology, thoracic
surgery and pediatrics. They can be used with suture or tissue staple supporting material. They also can be
used for transection and excision of liver parenchyma (hepatic vascular system and bile duct structure),
pancreas, kidney and spleen.
However, according to the Guidelines for Technical Review of Endoscopic Stapler Registration, "the surgical
site and/or tissue type and thickness selected for clinical trial shall cover the intended clinical applicable
scope of the product under application". Therefore, gastrointestinal surgery is selected for the clinical trial.
Therefore, the indication of this clinical trial is: "gastrointestinal tissue cutting and anastomosis".
8.1.6.2 Inclusion criteria
Subjects meeting all of the following conditions only can be included:
(1) Subjects are aged 18-70 years (inclusive), male or female;
(2) Subjects are scheduled to accept gastrointestinal tissue cutting and anastomosis;
(3) Subjects or their guardians are able to understand the purpose of the study, show adequate compliance
with the trial protocol, and sign an ICF.

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8.1.6.3 Exclusion criteria
Subjects meeting any of the following conditions can not be included:
(1) Subjects who are scheduled to receive gastrointestinal emergency surgery;
(2) Subjects with moderate malnutrition (BMI < 17 kg/m2) and severe anemia (Hb < 60 g/L);
(3) Subjects with a BMI ≥28 kg/m2;
(4) Subjects with platelet (PLT) < 60 × 10 9/L or international normalized ratio (INR) > 1.5;
(5) Subjects with a forced expiratory volume in one second (FEV1)/predicted value ≤50%, or a forced
expiratory volume in one second (FEV1)/forced vital capacity (FCV) ≤60%;
(6) Subjects with ejection fraction ≤50%;
(7)
Subjects with important organ failure or other serious diseases (e.g., the subject's aspartate
aminotransferase (AST), alanine aminotransferase (ALT), or serum creatinine (Scr) is more than 3 times
of the upper limit of normal before surgery; the subject's fasting blood glucose value before surgery is ≥
10.0 mmol/L);
(8) Subjects who are pregnant or lactating women;
(9) Subjects who have participated in other drug or device clinical trials within 3 months prior to the trial;
(10)Other situations not suitable for inclusion judged by the investigators.
8.1.7 Study termination criteria
Study termination refers to that the clinical study has not been completed according to the protocol, and all
clinical studies are stopped halfway. The purpose of terminating the clinical study is to protect the rights and
interests of the subjects and ensure the quality of clinical study. Except for Item 6 below, the sponsor and the
investigators shall jointly negotiate whether to terminate the trial:
(1) If serious safety problems occur during the clinical study, the clinical study should be terminated in a
timely manner;
(2) If the product is found to have no clinical value during the clinical study, the clinical study shall be
terminated;
(3) In the process of clinical study, it is found that the clinical study protocol has major errors and it is
difficult to evaluate the product effect; or the protocol has serious deviation in the implementation, in
which it is difficult to evaluate the product effect if the study is continuously to be conducted, , the
clinical study shall be terminated;
(4) The sponsor requests to terminate the study (for reasons, e.g., financial, etc.);
(5) The clinical trial institutions and investigators fail to comply with the laws and regulations related to
clinical trial and clinical trial protocol, and fail to make correction after being pointed out, resulting in

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serious situations or failure to change.
(6) NMPA orders to terminate the clinical study for some reason(s).
After the study is terminated, the investigators should continue to provide appropriate treatment for the
subjects from the perspective of protecting the rights and interests of the subjects, and inform the subjects of
the treatment received during the trial and related treatment in detail. The subject data continues to be
acceptable for evaluating the safety of the product.
The investigators should timely feed back the termination of the subject study to the sponsor.
8.1.8 Enrollment time
It is estimated that the first subject will be enrolled in June 2018. The total enrollment time is 6 months, and
the trial end time for the last subject will be December 2018.
8.1.9 Expected duration of clinical trial and the reasons for determination
The expected enrollment time for the first subject is June 2018. The enrollment time for subjects is 6 months.
The time for the last subject to complete the trial is December 2018. The time for statistical analysis and
preparation of study summary report after the completion of clinical trial is 2 months, and the total clinical
study period is 8 months.
8.1.10 Expected duration of participation of each subject
The expected screening period from signing the ICF to enrollment for each subject is 7 days, and the
postoperative follow-up period is about 30 days. The total subject observation period is 37 days. If a subject
experiences an adverse event during the clinical trial, the outcome of the adverse event needs to be observed.
8.1.11 Number of subjects required for clinical trial
The total sample size is 164. See Section 9.2 for details.
8.1.12 Drop-out criteria and treatment
(1) Definition of drop-out: All the subjects who have signed the ICF and passed screening to enter the
clinical trial, no matter when or when they withdraw from the study, will be called drop-out cases as long
as they have not completed the observation period specified in the protocol.
(2) Drop-out criteria:
a) The subject is unwilling or impossible to continue the clinical trial for any reason, and the clinical trial is
terminated by putting forward a request for withdrawal from the clinical trial to the investigator;
b) The subject is lost to follow-up due to no treatment or examination although the subject does not

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explicitly withdraw from the clinical trial;
c) If the subject experiences a serious adverse event (SAE), the investigator should withdraw the subject
from the clinical trial;
d) Poor subject compliance.
For all the dropout cases, it is necessary to fill in the summary form of completion of clinical trial in the case
report form and analyze the reasons for dropout. When a subject dropped out, the investigator should contact
the subject as far as possible, ask the reason and record the last clinical symptom, and complete the
evaluation items that could be completed. When withdrawing from the study due to adverse events, the
investigator should take appropriate treatment measures according to the actual situation of the subject.
When a subject or his/her guardian actively requests to withdraw from the trial, the subject or his/her
guardian should be asked that whether the subject’s previous data can be continuously used in the clinical
trial, and whether the results can be recorded in the original records. When no enquiry is performed, the data
are available by default.
8.1.13 Supplementary procedures for subjects
During the clinical trial, if the number of subjects fails to meet the statistical requirements due to dropout for
any reason, or the investigator considers it necessary to supplement subjects, the reasons shall be analyzed
firstly, and then the investigator, sponsor and statistician shall discuss whether to supplement or not. After
determining the number of supplemented cases, the information shall be submitted to relevant departments
for review.
8.1.14 Study completion criteria
Study completion refers to that the clinical study has included sufficient subjects according to the
requirements of clinical protocol and completed the treatment, observation and evaluation for all subjects,
and the collected data can be used to evaluate the safety and effectiveness of the study product.
8.1.15 Effectiveness evaluation method
8.1.15.1 Main effectiveness evaluation indicators, method and time for evaluation, recording and
analysis
(1) Success rate of anastomosis
Justification for selection: According to the Guidelines for Technical Review of Endoscopic Stapler
Registration issued by NMPA (original CFDA) on March 13, 2017, the "success rate of anastomosis" is
selected as the primary evaluation indicator for such products.
Evaluation time: During the surgery.

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Evaluation site: Tissues receiving linear stapler for gastrointestinal anastomosis.
Evaluation method: The transection and anastomosis of lung tissues are performed during the operation.
The device is withdrawn after successful triggering. The cutting staple line is carefully checked for integrity,
air leakage and bleeding. Anastomosis is considered as successful if all anastomotic rings are intact without
leakage or bleeding, otherwise it is considered as failure. If necessary, the gas injection method is used to
inspect whether there is bubble overflow at anastomotic stoma. If there is no bubble overflow, it is recorded
as successful anastomosis; if there is obvious bubble overflow, it is recorded as anastomosis failure.
Formula: Anastomosis success rate = number of subjects with successful anastomosis in each group/total
number of subjects in this group × 100%
Precautions: During gastrointestinal tissue cutting and anastomosis, the subject may be converted into
thoracotomy due to his complicated condition. At this time, the investigators need to determine whether the
subject's conversion to thoracotomy is caused by the stapler. If it is caused by the stapler, it is judged as
anastomosis failure. After gastrointestinal tissue anastomosis, the investigator may need to supplement the
stitching treatment for anastomotic tissues. If the supplement is resulted from incomplete anastomosis ring,
leakage and bleeding, it is considered as anastomosis failure.
8.1.15.2 Secondary effectiveness evaluation indicators, method and time for evaluation, recording and
analysis
(1) Stapler-resulted conversion rate
Justification for selection: The need for conversion to thoracotomy due to failed anastomosis increases the
risk to the subject. Therefore, the "stapler-resulted conversion rate" is selected as one of the effectiveness
indicators of the product. At the same time, with reference to the Guidelines for Technical Review of
Endoscopic Stapler Registration issued by NMPA (original CFDA) on March 13, 2017 , the "stapler-resulted
conversion rate" is selected as an effectiveness evaluation indicator for such products.
Evaluation time: During the surgery.
Evaluation method: Indicators of conversion to laparotomy are ①bleeding difficult to control; ②invasion
of adjacent organs or blood vessels resulting in difficulty in surgery; ③patients difficulty in tolerating
pneumoperitoneum during surgery; ④accidental injury of other organs during surgery, which are difficult for
treatment; ⑤severe intraoperative adhesions found during surgery. If the conversion to laparotomy is caused
by the stapler, it should be recorded truthfully.
Formula: Stapler-resulted conversion rate = number of eligible subjects in each group/total number of
subjects in this group × 100%
(2) Number of stitches repaired with staple line
Justification for selection: When the stapler is used for gastrointestinal tissue anastomosis, the situation that

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the staple line needs to be repaired may occur. When the number of repair needles becomes larger, it may
increase the risk to the subject. Therefore, the "number of stitches repaired with staple line" is selected as one
of the indicators to evaluate the effectiveness of the product. At the same time, with reference to the
Guidelines for Technical Review of Endoscopic Stapler Registration issued by NMPA (original CFDA) on
March 13, 2017 , the "number of stitches repaired with staple line" is selected as an effectiveness evaluation
indicator for such products.
Evaluation time: During the surgery.
Evaluation method: The number of staple line repair needles of each subject during operation is recorded.
Precautions: Anastomotic repair is required when the anastomotic ring is incomplete, leaking and bleeding.
Anastomotic repair may also be necessary when there is a dehiscence of the staple line during surgery.
Sometimes the investigators may perform anastomotic repair in order to strengthen the anastomotic site.
Therefore, the reasons for repair should be recorded.
(3) Operation time
Justification for selection: The main purpose of stapler is to reduce the surgeon's operation intensity and
save operation time. Therefore, the operation time is selected as one of the indicators to evaluate the product
performance. Meanwhile, with reference to the Guidelines for Technical Review of Endoscopic Stapler
Registration issued by NMPA (original CFDA) on March 13, 2017, the "operation time" is selected as the
secondary evaluation indicator for such products.
Evaluation time: During the surgery.
Evaluation method: The investigators record the time taken from thoracotomy to chest closure to the nearest
minute.
(4) Anastomosis time
Justification for selection: The main purpose of stapler is to reduce the surgeon's operation intensity and
save operation time. Therefore, the stapling time is selected as one of the indicators to evaluate the product
performance. Meanwhile, with reference to the Guidelines for Technical Review of Endoscopic Stapler
Registration issued by NMPA (original CFDA) on March 13, 2017, the "anastomosis time" is selected as the
secondary evaluation indicator for such products.
Evaluation time: During the surgery.
Evaluation method: The investigators record the time taken for the subject to perform the transection from
the completion of mobilization of gastrointestinal tissues (the first operation site) to the completion of
anastomosis of gastrointestinal tissues. The time is accurate to minutes.
(5) Anastomotic healing time
Justification for selection: Anastomotic healing is an important indicator for effectiveness and safety

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evaluation of such products. Therefore, the anastomosis time is selected as one of the indicators to evaluate
the product performance. Meanwhile, with reference to the Guidelines for Technical Review of Endoscopic
Stapler Registration issued by NMPA (original CFDA) on March 13, 2017, eventually, the "anastomotic
healing time" is used as a secondary indicator for evaluation.
Evaluation time: After surgery.
Evaluation method: The recovery of borborygmus and smooth eating and defecation are considered as
anastomotic healing. Only when the subjects meet these three criteria, it can be judged as the anastomotic
healing, and the latest time observed shall be the basis for evaluation. The time is accurate to day.
(6) Time of first flatus
Justification for selection: After gastrointestinal surgery, anus exhaust indicates the gradual recovery of
intestinal function and the gradual healing of anastomotic stoma, which is one of the markers for the gradual
recovery of patients undergoing gastrointestinal surgery. Meanwhile, with reference to the Guidelines for
Technical Review of Endoscopic Stapler Registration issued by NMPA (original CFDA) on March 13, 2017,
the "time of first flatus" is selected as a secondary evaluation indicator for such products.
Evaluation time: After successful operation to before discharge.
Evaluation method: After the surgery, the investigators instructed the subjects to pay attention to the time of
first anus exhaust. The subjects fed back to the physician after feeling the first flatus. The time is accurate to
day.
(7) Time of first bowel movement
Justification for selection: After gastrointestinal surgery, the intestinal function gradually recovers. When
the patients can recover spontaneous defecation, it indicates that the anastomotic stoma gradually heals,
which is one of the markers for the gradual recovery of patients undergoing gastrointestinal surgery.
Meanwhile, with reference to the Guidelines for Technical Review of Endoscopic Stapler Registration issued
by NMPA (original CFDA) on March 13, 2017, the "time of first bowel movement" is selected as a secondary
evaluation indicator for such products.
Evaluation time: After successful operation to before discharge.
Evaluation method: The investigators observed the time for subjects to recover spontaneous defecation for
the first time after operation. The time is accurate to day.
(8) Time of eating semi-liquid food
Justification for selection: After gastrointestinal surgery, the intestinal function gradually recovers when the
patients eat semi-liquid food, which indicates that anastomotic stoma gradually heals, which is one of the
markers for patients undergoing gastrointestinal surgery. Meanwhile, with reference to the Guidelines for
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the "time of eating semi-liquid food" is selected as a secondary evaluation indicator for such products.
Evaluation time: After successful operation to before discharge.
Evaluation method: The investigators determine whether the subject can eat semi-liquid food according to
his/her recovery, and record the time of eating semi-liquid food. The time is accurate to day.
8.1.16 Safety evaluation method
(1) Incidence of anastomotic stoma dehiscence
Justification for selection: When stapler is used for intestinal anastomosis, it is necessary to select
appropriate reload. Dehiscence of the anastomotic stoma may increase the risk to the subject. Therefore, the
"incidence of anastomotic stoma dehiscence" is selected as one of the safety indicators of the product under
evaluation. At the same time, with reference to the Guidelines for Technical Review of Endoscopic Stapler
Registration issued by NMPA (original CFDA) on March 13, 2017, the "incidence of anastomotic stoma
dehiscence" is selected as a safety evaluation indicator for such products.
Evaluation time: During the surgery.
Evaluation method: Anastomotic stoma dehiscence due to "staple popping" during surgery is recorded.
Formula: Incidence rate of anastomotic stoma dehiscence = number of eligible subjects in each group/total
number of subjects in the group × 100%
(2) Incidence of anastomotic stoma bleeding
Justification for Selection: Anastomotic stoma bleeding is a common complication in gastrointestinal
anastomosis procedures, which will increase the risk to subjects. Therefore, "the incidence of anastomotic
stoma bleeding" is selected as one of the indicators to evaluate the product safety. Meanwhile, with reference
to the Guidelines for Technical Review of Endoscopic Stapler Registration issued by NMPA (original CFDA)
on March 13, 2017, the "incidence rate of anastomotic stoma bleeding" is selected as a safety evaluation
indicator for such products.
Evaluation time: from the end of surgery to the end of follow-up.
Evaluation method: Alimentary tract bleeding occurs after operation, and is confirmed as the anastomotic
stoma source by observing digestive cavity decompression tube and intraperitoneal drainage tube, endoscope
and angiography. If the source is not identified, it is then called gastrointestinal bleeding.
Formula: Incidence rate of anastomotic stoma bleeding = number of eligible subjects in each group/total
number of subjects in the group × 100%
(3) Incidence of anastomotic leakage
Justification for selection: Anastomotic leakage is a common complication of gastrointestinal anastomosis,
which will increase the risk to subjects. Therefore, the "incidence of anastomotic leakage" is selected as one
of the safety indicators for product evaluation. At the same time, with reference to the Guidelines for

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Technical Review of Endoscopic Stapler Registration issued by China Food and Drug Administration on
March 13, 2017, the "incidence of anastomotic leakage" is selected as a safety evaluation indicator for such
products.
Evaluation time: From the end of surgery to the end of follow-up.
Evaluation method: Patients with at least one of the following items are considered as anastomotic leakage:
A. imaging examination, such as gastrointestinal radiography, confirms anastomotic leakage; B. fecal
substances appearing in the abdominal drainage tube or incision, in which other sources of intestinal tract can
be excluded; C. reoperation exploration confirms anastomotic leakage; D. abdominopelvic abscess beside the
anastomosis. Anastomotic leakage is divided into 3 grades according to the severity: Grade A: no special
treatment is required; Grade B: active treatment is required, but no reoperation is required; Grade C:
reoperation is required.
Formula: Incidence of anastomotic leakage = eligible subjects in each group/total number of subjects in this
group × 100%
Precautions: Necessary records should be kept for the treatment of anastomotic leakage.
(4) Incidence of anastomotic stricture
Justification for Selection: Anastomotic stricture is a common complication of gastrointestinal anastomosis,
which will increase risks to subjects. Therefore, "the incidence of anastomotic stricture" is selected as one of
the indicators to evaluate the product safety.
Evaluation time: From the end of surgery to the end of follow-up.
Evaluation method: The clinician judges whether the subject has an anastomotic stricture based on the
symptoms, signs, endoscopy, angiography, etc.
Formula: Incidence rate of anastomotic stricture = eligible subjects in each group/total number of subjects in
the group × 100%
(5) Incidence of anastomotic stricture infection
Justification for Selection: Anastomotic stricture infection is a common complication of gastrointestinal
anastomosis, which will increase risks to subjects. Therefore, "the incidence of anastomotic stricture
infection" is selected as one of the indicators to evaluate the product safety.
Evaluation time: from the end of surgery to the end of follow-up.
Evaluation method: The clinician judges whether the subject has a staple line infection based on the
symptoms, signs, endoscopy, angiography, etc.
Formula: Incidence rate of anastomotic stricture infection = eligible subjects in each group/total number of
subjects in the group × 100%
(6) Incidence of SAE (serious adverse event)

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Evaluation time: During the whole clinical trial process.
Evaluation method: Serious adverse event refers to an event occurs in the process of clinical trials, which
results in death or serious deterioration of health, including fatal disease or injury, permanent damage to the
body structure or function, requiring hospitalization or prolonging the hospitalization, requiring medical or
surgical intervention to avoid the permanent damage to the body structure or function; results in fetal distress,
fetal death or congenital abnormality, congenital defect, etc.
Formula: SAE incidence = number of subjects with SAE in this group/number of all subjects in this group ×
100%.
Precautions: The adverse events related to the anastomotic stoma during clinical trial shall be considered as
serious adverse events. Since "anastomotic stoma repair" may be associated with "anastomotic stoma
dehiscence", the “anastomotic stoma repair "is not repeatedly considered a serious adverse event.
(7) Incidence of AE (adverse event)
Evaluation time: During the whole clinical trial process.
Formula: Incidence of adverse events = number of subjects with adverse events in this group/number of all
subjects in this group × 100%.
Definition: An adverse event is any untoward medical occurrence in a clinical investigation, whether or not
related to the device. It is necessary to analyze the postoperative vital signs and laboratory tests (blood
routine, biochemical indicators, etc.).
(8) Incidence of device defects
Measurement time: During the whole process of clinical trial.
Calculation formula: Incidence of device defect = number of device defects/total number of devices ×
100%.
Precautions: A test device defect that occurs during the course of a clinical trial. "Staple pop" due to human
factors (e.g., incorrect reload selection) is not a defect of the device.
8.1.17 Operational performance evaluation
(1) Stapler operating performance evaluation
Measurement time: During the stapler operation process.
Evaluation method: ①Whether the single-handed operation of stapler is smooth; ②whether the stapler can
fire normally; ③whether the back-off is smooth after the completion of anastomosis, whether there is tissue
entrapment, whether there is resistance; ④whether the stapler can fire continuously for many times is
reliable; ⑤whether the stapler can completely cut off the tissue; ⑥whether the battery supply is stable; ⑦
whether the electric cutting is smooth.

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8.2 Test Process
8.2.1 Test Flow Chart
Visit Time
Visit Item
Visit 1
Visit 2
Visit 3
Visit 4
Before surgery
(Day -7 ~ 0)
During surgery
(Day 0)
After surgery
(Day 7 ± 2 days)
After surgery
(Day 30 ± 5 days)
Informed consent
▲
Subject screening
▲
Demographic data
▲
History of present illness
▲
Past medical history
▲
Vital signs
▲
▲
▲
▲
Blood routine
▲
▲
Coagulation routine
▲
▲
Blood biochemistry
▲
▲
Cardiac examination
▲
▲
▲
Pulmonary function test
▲
Arterial blood gas
analysis
▲
Preoperative imaging
▲
Blood pregnancy test1
▲
Randomization
▲
Intraoperative
observation record
▲
Use of device
▲
Postoperative imaging2
▲
Postoperative follow-up
observation
▲
▲
Concomitant medication
▲
▲
▲
▲
Adverse events
▲
▲
▲
▲
Device defect
▲
1
Only for women of childbearing potential.
2
In case of anastomotic leakage and bleeding, the investigators may perform relevant examinations for the subjects
according to actual needs.

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8.2.2 Enrollment
The investigators screened the subjects according to the inclusion and exclusion criteria after obtaining their
informed consent; before the day of conducting gastrointestinal tissue cutting and anastomosis, the subjects
were randomly divided into the test group and the control group according to the random assignment
instructions.
8.2.3 Randomization
The trial was stratified by clinical trial institutes with the randomization method of stratified blocks. The seed
number and block length were determined with SAS9.1 statistical software programming. The subjects were
divided into the test group and the control group in a ratio of 1:1. The random grouping arrangement of at
least 164 subjects was generated, and the corresponding sequentially numbered, opaque and sealed
randomization envelopes were made. The randomization envelopes were kept and allocated by relevant
personnel who were not involved in the screening and treatment of subjects and authorized by the
investigator.
The random number is a 4-digit sequential number consisting of "center number" and "serial number" (which
is generally the “center digit occupied + sample size digit occupied”). The first digit is the number of the
clinical trial institution, and the last 3 digits are the "serial number" assigned by randomization. When the
serial number is less than 3 digits, add “0” to make up 3 digits. If the randomization number "1001" is the
first randomization number of the clinical trial institute with the institute number of 01, it corresponds to the
first subject randomized at the institute.
When a subject was determined to be enrolled, the investigators or other authorized designee requested
randomization assignment from the randomization envelope manager. The randomization envelope keeper
took out the randomization envelope in the order of random number, filled in the screening number and
initials of the subject to be assigned to the designated place on the back of the envelope, and signed the name
and date to complete the allocation. The investigators or other authorized designee then intervened based on
the results of the randomization assignment (i.e., test groups).
8.2.4 Blinding method
The investigators could not be blinded due to the difference in appearance between the test device and the
control device, this trial therefore adopted an incomplete blinding method, and the subjects were not
informed of the randomization results (i.e., the subjects did not know their own treatment assignment).

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8.2.5 Inspection items
8.2.5.1 Medical history and vital signs
(1) Demographic data: gender, date of birth;
(2) History of present illness: admission time, surgical site 3;
(3) Past medical history: allergy history, dysfunction history of vital organs (heart, lung, liver and kidney),
surgery history, and previous medication history 4 (within 1 month);
(4) Vital signs: height, weight, blood pressure, pulse, temperature, respiration, BMI 5;
8.2.5.2 Laboratory examinations
(1) Blood routine: hemoglobin (Hgb), red blood cell count (RBC), white blood cell count (WBC), neutrophil
count (NEUT), neutrophil ratio (NEUT%), platelet count (PLT);
(2) Coagulation blood routine: prothrombin time (PT), activated partial thromboplastin time (APTT),
international normalized ratio (INR);
(3) Cardiac examination: ECG, cardiac ejection fraction;
(4) Fasting blood glucose 6;
(5) Fecal examination: occult blood test;
(6) Cardiac ultrasonography: cardiac ejection fraction;
(7) Pulmonary function test: forced expiratory volume in one second (FEV1)/predicted value, forced
expiratory volume in one second (FEV1)/forced vital capacity (FVC);
(8) Blood pregnancy test: applicable to women of childbearing age (18 ~ 50 years old);
8.2.5.3 Preoperative imaging 7
(1) CT examination: tumor stage, whether there is liver metastasis, whether there is pelvic metastasis,
whether there is lung metastasis;
8.2.5.4 Post-operative imaging 8
(1) Angiography: whether there is anastomotic bleeding;
(2) Upper gastrointestinal radiography: whether there is anastomotic leakage and stricture;
3 The data can be completed after the end of surgery.
4 Mainly record drugs that affect healing (e.g., antineoplastic agents, corticosteroids) or coagulation.
5 Body mass index (BMI) = weight (kg) ÷ height2 (m2)
6 Combined with clinical practice, the subjects enrolled in this trial are all hospitalized patients who will receive routine blood
biochemical examination (including blood glucose item), and the blood glucose value in the blood biochemical results of hospitalized
patients after blood collection in the morning is generally fasting blood glucose value; if the subject does not have fasting blood
glucose value, the blood glucose value (≤10.0 mmol/L) is also used for screening confirmation; this is acceptable to be the fasting
blood glucose data in the screening period. The investigators may choose to do this according to the subject's condition.
7 If the subject is a non-tumor patient, such examination may not be performed, and the CRF should be completed as "Not Applicable".
8 In case of anastomotic leakage, stricture and bleeding, the investigators may decide whether the subject will receive angiography,
upper gastrointestinal radiography and gastrointestinal endoscopy according to actual needs. If relevant examination is not required, the
CRF should be completed as "Not Applicable".

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(3) Gastrointestinal endoscopic examination: whether there is anastomotic leakage and stricture;
(4) Abdominal CT: whether there is abdominal effusion and the amount of abdominal effusion;
8.2.5.5 Other tests:
(1) Intraoperative observation items: name of operation, start time of operation, end time of operation, start
time of anastomosis, end time of anastomosis and intraoperative blood loss;
(2) Observation of the study product9: whether the digestive tract is successfully transected and stapled,
whether the cutting anastomosis ring/staple line is complete, whether there is leakage of cutting
anastomosis ring/staple line, whether there is bleeding of cutting anastomosis ring/staple line, whether
there is bubble overflow at the anastomotic stoma10, whether there are indicators of conversion to
laparotomy11, number of needles for anastomotic repair11, whether there is anastomotic dehiscence11,
whether there are other complications11, whether the staple line or tissue buttressing materials are used,
and the operating performance of stapler;
(3) Device use12: model and specification of electric stapler, model of cartridge, use condition13, cutting and
stapling tissues14, device defects;
(4) Postoperative follow-up observation: first anus exhaust time, semi-liquid feeding time, first defecation
time, bowel sound recovery time, whether there is anastomotic bleeding15, whether there is anastomotic
leakage15, whether there is anastomotic stenosis15, whether there are other complications15, whether there
is abdominal effusion and the abdominal effusion volume;
(5) Routine observation items: adverse events, concomitant medication, protocol deviations.
8.2.6 Device using specification
According to the results of random allocation, the investigators apply the study medical device to the subjects
who enter the test group, and the control medical device to the subjects who enter the control group. If a
subject requires the use of a circular stapler during the trial, the brand and model of the circular stapler shall
be recorded.
9 Only the conditions related to the use of test product and control product are recorded here. However, during the trial, subjects may
use circular stapler or other staplers. If adverse events related to the stapler also occur, the occurrence shall be truthfully recorded in the
adverse events.
10 It is necessary to use gas injection method for inspection. If relevant examination is not required, the CRF should be completed as
"Not Applicable".
11 If yes, please specify the reason and whether it is related to the stapler.
12 The model and amount used in the clinical trial shall be truthfully recorded. Meanwhile, whether the subject uses the brand and
model of circular stapler shall also be collected.
13 Investigators faithfully record whether each reload is used laparoscopically or laparotomically.
14 The tissues cut and anastomosed by each cartridge, such as stomach, duodenum, jejunum, ileum, appendix, ascending colon,
transverse colon, descending colon, sigmoid colon and rectum, etc. are recorded.
15 If corresponding symptoms occur, the reasons for confirming the event should also be briefly described, so as to facilitate the
review. In addition, generally anastomotic bleeding is judged by the presence or absence of persistent fresh bleeding from the gastric
tube, and the diagnosis is confirmed by gastroscopy or second surgical exploration.

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8.2.7 Visit schedule
Subjects should receive 4 visits before the end of the study: before surgery (Day -7 ~ 0), during surgery (Day
0), on Day 7 ± 2 after surgery, and on Day 30 ± 5 after surgery.
8.2.7.1 1st visit 1/before surgery (Day -7 ~ 0)
(1) The ICF form shall be signed;
(2) Screening subjects according to the inclusion and exclusion criteria;
(3) Recording demographic data, current medical history and past medical history are recorded;
(4) Examining vital signs;
(5) Performing preoperative imaging examination16 (CT examination);
(6) Performing laboratory examinations17 (blood routine, coagulation routine, blood biochemistry, fasting
blood glucose, occult blood test, cardiac ultrasound, pulmonary function, blood pregnancy test) ;
(7) Recording concomitant and concomitant medications;
(8) Recording protocol deviations;
8.2.7.2 2nd visit 2/during surgery (Day 0)
(1) Examining vital signs;
(2) Intraoperative observation records (intraoperative observation, observation of investigational product,
use of device);
(3) Randomization;
(4) Use of device;
(5) Recording concomitant medication/treatment;
(6) Monitoring of adverse events and serious adverse events;
(7) Recording device defects;
(8) Recording protocol deviations;
8.2.7.3 3rd visit 3/after surgery (Day 7 ± 2 days)
(1) Examining vital signs;
(2) Conducting laboratory examinations (blood routine, coagulation routine, blood biochemistry, occult
blood test);
(3) Conducting postoperative imaging examinations (angiography 8, upper gastrointestinal radiography 8,
gastrointestinal endoscopy 8, postoperative abdominal CT) ;
(4) Postoperative follow-up observation;
16 For imaging examination, reports/results within 1 month prior to surgery in our hospital my be accepted.
17 For laboratory examination, reports/results at within 7 days prior to surgery in our hospital may be accepted.

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(5) Postoperative follow-up observation;
(6) Recording concomitant and combined medications;
(7) Recording adverse events and serious adverse events;
(8) Recording protocol deviations;
8.2.7.4 4th visit/after surgery (Day 30 ± 5 days)
(1) Examine vital signs;
(2) Occult blood test;
(3) Conducting postoperative imaging examinations (angiography, upper gastrointestinal radiography,
gastrointestinal endoscopy) 8;
(4) Postoperative follow-up observation (anastomotic healing time, whether there is anastomotic bleeding,
whether there is anastomotic leakage, whether there is stricture and other complications);
(5) Recording concomitant and combined medications;
(6) Monitoring adverse events and serious adverse events;
(7) Recording protocol deviations;
8.2.8 Concomitant medication/treatment management
If a subject takes medication or therapeutic measures that caused the AE for various reasons during the study,
such situation shall be recorded in the case report form (CRF) by investigators for reference.
(1) Prohibited therapies: Products with similar efficacy to the study medical device and the control device
are prohibited for use by all subjects during the clinical trial.
(2) Allowable treatment: The treatment with other drugs or therapeutic measures required due to underlying
diseases, concomitant diseases or adverse events should be recorded in the original medical records in
detail, including the name, dosage, usage of the drug and the name, usage and frequency of the
therapeutic measures.
(3) The generic name, type, dose, frequency, route of administration and days of administration of other
drugs used by the subjects as well as the name, method and frequency of treatment should be recorded in
detail. The information is used to evaluate the possible bias on clinical trial results.
8.2.9 Case report form completion
Case Report Form (CRF) is a document designed according to the clinical protocol to record the data of each
subject during the trial. The correct completion of case report form will help to make a correct judgment on
the trial results. Each investigator should complete the case report form carefully and pay attention to the
following points:
(1) Required fields on the CRF must not be left blank;

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(2) When completing the CRF, be sure to make the unit of test results consistent with the unit filled in;
(3) All data on the CRF should be derived from original documents and be consistent with the original
documents;
(4) The investigator should complete and sign the CRF within 2 weeks after each subject completes relevant
examinations, which is for overall monitoring by the clinical research associate;
(5) If there is any uncertainty in the filling process, please communicate with the sponsor in a timely manner.
8.3 Monitoring Plan
The sponsor shall, in accordance with the requirements of Good Clinical Practice for Medical Devices, select
the qualified monitor to perform monitoring responsibilities for all the participating institutions. The
monitoring frequency of each participating institution will be adjusted according to the speed of subject
recruitment and subject number in each institution participating in the study. The monitor will complete the
following responsibilities:
(1) Confirming that the clinical trial institution has been equipped with appropriate conditions before the
trial, including qualified staffing and training, complete laboratory equipment, good working condition,
expected to have a sufficient number of subjects, and investigators familiar with the trial requirements;
(2) Monitoring whether the clinical trial institutions and investigators abide by relevant regulations, this
specification and clinical trial protocol before, during and after the trial;
(3) Confirming that each subject has signed the ICF before participating in the clinical trial, and that the
inclusion of subjects as well as the progress of the trial are well known; monitoring and recording the
failure follow up, non-conducted trial, non-conducted examination by the investigators, and whether the
errors and omissions are corrected; for the revised ICF, confirming that the clinical trial process is not
completed and the affected subjects have re-signed the ICF;
(4) Confirming that all the CRFs are correctly filled in and consistent with the original data; that all the
errors or omissions have been corrected or explained, which have been signed and dated by the
investigators; and that the disease type, total number of cases and gender, age and therapeutic effect in
each trial have been confirmed and recorded;
(5) Confirming that the subject withdrawing from the clinical trial or non-compliant with the requirements
set forth in the ICF is recorded and discussed with the investigators;
(6) Confirming that all adverse events, complications and other device defects are recorded, and serious
adverse events and device defects that may cause serious adverse events are reported and recorded
within the specified time;
(7) Monitoring the supply, use, maintenance, transportation, reception, storage, distribution, processing and
recovery of investigational medical device samples;

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(8) Supervising the regular maintenance and calibration of relevant equipment during the clinical trial;
(9) Ensuring that all the documents related to the clinical trial received by the investigators are of the latest
version;
(10)Submitting a written report to the sponsor after each monitoring, which shall include the name of the
monitor, date of monitoring, time of monitoring, place of monitoring, content of monitoring, name of the
investigator, completion status of the project, existing problems, conclusions, and corrections to errors
and omissions, etc.
9. Statistical Considerations
9.1 Statistical Design, Methods and Analysis Procedure
This study is a prospective, multi-center, stratified block randomization, incomplete blinding, parallel
positive control and non-inferiority test. All statistical analysis methods are detailed in the statistical analysis
plan. The first draft of the statistical analysis plan will be formed after the trial protocol and case report forms
are finalized and will be finalized before database lock.
9.2 Sample Size Calculation
9.2.1 Total sample size
164 subjects are planned to be enrolled in this clinical trial. The sample size determination process is as
follows:
This clinical study is a parallel positive control clinical validation design. The "anastomosis success rate" is
adopted as the basis for sample size estimation. Based on literature review
[3-11], the success rate of
anastomosis is up to 100% when the similar devices are used for total laparoscopic distal gastrectomy for
gastric cancer. According to relevant literatures and considering clinical practice, when such products are
used for anastomosis from esophageal site to gastrointestinal site, the "success rate of anastomosis" can reach
97%. Therefore, the "anastomosis success rate" of this clinical trial is determined to be 97% with a clinical
non-inferiority margin of 10%. The parameters are set as follows: α = 0.025 (one-sided), β = 0.2, δ = 10%,
and the ratio of test control group is 1:1. The estimation formula of sample size for non-inferiority clinical
validation is adopted, and the sample size required in each group is at least 65 cases. The calculation formula
[12] and correction formula [13] are as follows:

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Considering that the number of subjects who may drop out or be lost to follow-up during clinical validation is
about 20%, the sample size of each group is expanded to 82 cases, and the total sample size required for the
two groups is 164 cases.
9.2.2 Number of cases for clinical trial of each disease and reasons for determination
The investigational product is mainly used for the cutting and anastomosis of gastrointestinal tissues, other
diseases therefore are not involved in this clinical trial.
9.2.3 Minimum and maximum number of subjects in each clinical trial institution and reason
A total of 164 subjects are planned to be enrolled in this clinical trial, and a total of 5 clinical trial institutions
are planned to participate in this trial. In the trial, the sample balance in each site should be maintained as far
as possible. In combination with the total sample size and the number of participating clinical trial
institutions, considering different number of disease sources in each center and possible difficulties in
individual centers, each clinical trial institution should recruit at least 16 subjects but no more than 60
subjects.
9.3 Significance Level and Power of Clinical Trial
Significance level α (one-sided) = 0.025 with 80% power.
9.4 Expected Dropout Rate
A 20% dropout rate is expected during sample size estimation.
This drop-out rate refers to the proportion of subjects who finally can not be included in the primary analysis.
Drop-out subjects refer to those confirmed by the principal investigator with serious protocol violation
(affecting the main evaluation/efficacy evaluation). The following conditions may be included, but not
limited to: the subject violates the inclusion and exclusion criteria; the subject does not receive any
examination/treatment with the study device; the subject receives the concomitant medication/device
prohibited by the protocol; the data of main evaluation indicators are missing; the subject fails to obtain any
data after randomization; the subject fails to complete the follow-up visit according to the regulations.
9.5 Qualification/Disqualification Criteria for Clinical Trial Results
The non-inferiority hypothesis is tenable if the lower limit of 95% confidence interval of the difference in the
primary effectiveness evaluation indicator between the test group and the control group is greater than the
non-inferiority critical value (-10%).
The secondary effectiveness evaluation indicators and safety evaluation indicators are tested by difference
test, and the significance level is set at 0.05. If the test result of the difference in any secondary evaluation
indicator and safety evaluation indicator between the test group and the control group is p > 0.05, then there
is no significant difference in this indicator between the test group and the control group.

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9.6 Criteria and Reasons for Terminating Trial Based on Statistical Reasons
No interim analysis will be performed for this study, therefore, no standard for terminating the trial for
statistical reasons is developed.
9.7 Statistical Methods of Data, Together with Processing Methods of Missing, Unused or Wrong Data
and Unreasonable Data
9.7.1 Statistical method for data
Statistical analysis is performed using the SAS 9.1 software.
Statistical description on all data, including demographic data, baseline data, all efficacy indicators and all
safety data shall be performed. Measurement data will be statistically described using mean, standard
deviation, minimum, maximum, median, 25th percentile and 75th percentile; enumeration data will be
statistically described using frequency and percentage.
The primary effectiveness evaluation indicator (anastomosis success rate) is evaluated by the confidence
interval method.
The secondary evaluation indicators are evaluated by the difference test. Measurement data are compared
using two independent samples t-test or Wilcoxon rank sum test. Enumeration data are compared using
Pearson's X2 test or Fisher's exact test.
The safety evaluation indicators are evaluated by the difference test. Enumeration data are compared using
Pearson's X2 test or Fisher's exact test. The adverse events and device defects occur in this trial shall be
shown in list.
The stapler operational performance is evaluated by the difference test. Enumeration data are compared using
Pearson's X2 test or Fisher's exact test.
The central effect is considered in the analysis process. The general linear model is used for measurement
data, and CMH or logistic regression is used for enumeration data.
9.7.2 Missing, unused, or incorrect data (including dropouts and withdrawals) and unreasonable data
All missing, unused or incorrect data (including dropouts and withdrawals) and unreasonable data will be
discussed and finally determined by the investigators and biostatistician in the data review stage. The basic
statistical principles for the processing of these data are as follows:
(1) The details of each drop-out case shall be described, and the drop-out between the test group and the
control group shall be compared using Pearson X2 test or Fisher exact test;
(2) Missing data at baseline shall not be estimated;
(3) Missing values of main evaluation indicator (success rate of anastomosis) shall not be estimated;

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(4) Missing values of secondary evaluation indicators shall not be estimated;
(5) Missing values for operational performance evaluation shall not estimated;
(6) The wrong and unreasonable data shall be regarded as missing values;
(7) Missing values for all safety measures shall be estimated using the worst case;
(8) Sensitivity analysis shall be performed on the safety data set for all the safety evaluation indicators after
treatment.
(9) Missing data shall be statistically analyzed in the table.
9.8 Procedures for Reporting Deviations from Original Statistical Plan
In general, only the statistical analysis contents pre-specified in the statistical analysis plan can be presented
in the clinical trial report of this trial. The increased need for statistical analysis due to various indeterminate
reasons will be considered exploratory only.
9.9 Selection Criteria and Reasons for Subjects Included in Analysis
(1) Full analysis set (FAS): According to the basic principles of intention to treat analysis, all the subjects
who have received at least one treatment with the investigational medical device and had at least one
post-baseline observation data are included in the FAS. The FAS will be used as the primary population
for baseline data (and efficacy evaluation) in this study.
(2) Per-protocol set (PPS): It refers to the subjects in the FAS who do not seriously deviate from the trial
protocol, have good compliance and have no missing primary efficacy indicators. The PPS will be used
as the primary population for efficacy analysis in this study.
(3) Safety set (SS): All subjects who have received at least one treatment with the investigational medical
device and had at least one safety evaluation. The SS will be used as the primary population for safety
analysis in this study.
9.10 Exclusion of Special Information During Hypothesis Validation and Reasons
Not applicable.
10. Data Management
10.1 Database Design
The CRF designer is responsible to annotate the final version of the blank CRF and describe in detail the
necessary elements (e.g., variable name, length, type, range of the database variable, etc.).
The database designer determines the requirements for database establishment and database structure
according to CRF and annotated CRF, and designs the database.
The database must be thoroughly tested to ensure that the contents and structure of the database are
consistent with those of the CRF and annotated CRF, that the specified data are appropriately entered into the

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database, and that the entered data points are correctly exported into the corresponding database variables.
The database can be officially released for use only after it is approved.
10.2 Data Receipt and Data Entry
Data may be received by mail, courier with tracking for confidentiality, hand delivery by the monitor, web
entry, or other electronic means. When the paper CRF data is received, it shall be recorded in the data
receiving record form. After the completion of data receiving, the CRF shall be scanned and backed up; the
data received via network or other electronic means shall be stored in the corresponding documents and
records to confirm the data source.
Data entry can be double-entered by blind verification (two persons independently enter the data, and the
inconsistency is resolved at the second entry), and double-entered by interactive verification (the second
entry resolves the inconsistency between the two entries, and pays attention to the value of the first entry),
manual review of single entry and other forms.
Prior to data entry, the data manager shall train the entry clerk or investigators on system operation or matters
specific to this study.
After the completion of data entry, the database data shall be checked with original data to ensure that the
database data are consistent with original data.
10.3 Management of Data Verification and Query
Data verification includes manual inspection of data, and computer verification designed for identification
error, invalid data range, data integrity, protocol violation and consistency inspection. Data administrator
shall complete relevant procedures of preparing and approving the Data Verification Plan before the first data
receipt to determine the data verification content. Programmer will program and test the verification
procedure according to the finalized Data Verification Plan.
Based on the results of manual inspection and computer verification, the data administrator will resolve the
doubtful data in the form of data query form, data processing agreement and self-evident correction, and
update the database according to the answers or descriptions in relevant documents.
10.4 Database Lock and Data Archiving
The clinical trial database must be closed and locked to ensure the consistency and integrity of the data
results, data analysis and data submitted to the official authorities.
When all data have been received and all data cleaning has been completed, all queries have been answered,
all unanswered questions have been explained, the data review report has been confirmed, the division of
statistical analysis dataset has been clarified, and the data quality control has been completed (the database
quality is up to standard), the data administrator shall apply for database locking to the project team members.

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After being jointly confirmed by the investigators, the sponsor and project team members, the data editing
authority of the database will be taken back to lock the database. After the database is locked, the data
administrator shall transfer the data to the statistical analysis department in a timely manner. If data
correction is required, the review and approval of Database Unlock Application Form shall be completed, and
the database shall be unlock, so that corresponding personnel can enter the database to correct the data.
The data administrator shall establish the Data Management Project Folder, and shall be responsible for
archiving the data or record files when they meet the conditions for archiving. Upon completion of the study,
the data administrator will revoke the database access of relevant personnel, create a copy of the database,
and archive the study documents and data management documents.
11. Feasibility Analysis
11.1 Probability Analysis of Success
(1) According to the relevant clinical trials, it shows that such product is safe and reliable; and such product
has been used in clinical practice for many years, and its safety and reliability have been verified.
(2) The company producing the study medical device has rich experience. The product quality is reliable and
meets the requirements of clinical trials; the device has passed the product registration inspection
designated by NMPA (original CFDA).
(3) The clinical institutions undertaking this trial have complete instruments, equipment and technical
resources.
(4) The investigators are excellent academic leaders in related disciplines in China, all of whom are
physicians at or above the deputy director level, have rich clinical trial experience, have received GCP
and relevant training, and can carry out treatment in strict accordance with the clinical trial protocol.
11.2 Probability Analysis of Failure
(1) Too many subjects withdrawing from the trial due to SAE;
(2) Too many subjects lost to follow-up;
(3) The IFU and label information of test product can not effectively instruct the operator;
(4) Unskilled operation of investigators.
11.3 Conclusion
In conclusion, this product can be used for the anastomosis of gastrointestinal tissues to benefit relevant
patients. This study has great feasibility and high possibility of success.
12. Quality Control of Clinical Trial
12.1 Quality Assurance

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12.1.1 Definition
Quality assurance is defined as planned and systematic activities. These activities are established to ensure
that the study, generation, citation (recording) and reporting of data are conducted in compliance with Good
Clinical Practice (GCP) and applicable regulatory requirements.
12.1.2 Audit
Audit refers to a systematic independent inspection of clinical trial-related activities and documents
organized by the sponsor to determine whether the implementation of such activities and the recording,
analysis and reporting of data comply with the clinical trial protocol, standard operating procedures, GCP and
relevant applicable management requirements.
12.1.3 Inspection
Inspection refers to the activities of the food and drug regulatory authority in reviewing and supervising
relevant documents, facilities, records and other aspects of a clinical trial.
12.1.4 Clinical trial monitoring
The sponsor shall be responsible for comprehensively tracking and monitoring the implementation of clinical
trial, ensuring that the trial is conducted in compliance with GCP and relevant regulations, and is in
compliance with the trial protocol. NMPA (original CFDA) may also inspect the clinical trial during or after
the trial is completed, and promptly notify the sponsor if investigators receive such notification.
The monitor will make periodic visits to the conduct and completion of the trial. Monitors will check the
completeness of case records, the accuracy of case report form content, verify trial data, check the
investigator's compliance with the trial protocol and the GCP, and ensure the accuracy of distribution, storage
and counting of the study device.
12.2 Quality Control
12.2.1 Definition
Quality control is defined as operational techniques and activities performed under a quality assurance
system, such as monitoring, which is intended for verifying that the study-related activities meets the
requirements.
Quality control should be applied to each stage of data processing to ensure that all data are credible and
correctly processed.

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12.2.2 Study monitoring
The authorized and qualified monitor will visit the clinical trial centers regularly according to the monitoring
plan to verify the source data, the investigator's compliance with the protocol and regulations, and to assist
the investigators.
12.2.3 Laboratory quality control
Each clinical trial center laboratory should establish unified standards for experimental test indicators,
standard operating procedures and quality control procedures. Each experimental test item must adopt the
national legal unit of measurement, and the test report items must be complete (including date, test item, test
result and normal range), and relevant personnel should sign the report. Special inspection items must be
specially assigned to be tested.
12.2.4 Quality control for other inspections
Each clinical trial center should establish unified evaluation criteria, standard operating procedures and
quality control procedures for the evaluation of vital signs and damage. Each clinical trial center should
evaluate the subject's condition according to the unified standard and standard operating procedures.
12.2.5 Qualification of study personnel
The investigators participating in the clinical trial must have the professional expertise, qualification and
ability of clinical trials, and pass the qualification review. The personnel requirements shall be relatively
fixed.
12.2.6 Study staff training before study initiation
The sponsor is responsible for the training of study personnel before the start of the trial to help the clinical
study personnel get a full understanding and understanding of the overall situation of the trial, protocol, CRF,
etc.
13. Ethical Issues and Informed Consent of Clinical Trial
13.1 Ethical Considerations
This clinical trial must be carried out in accordance with the Declaration of Helsinki, relevant medical device
clinical trial regulations and laws in China. The study protocol must be approved by the Ethics Committee
(EC) of the clinical trial institute before the study is initiated.
Before each subject is enrolled in the study, the study physician is responsible for explaining the contents of
the trial to the subject in a verbal or written language understandable to the subject and carefully answering

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the subject's questions. Each subject must be given a written subject informed consent prior to enrollment. It
is the responsibility of the study physician to obtain informed consent prior to each subject entering the study
and to retain it in the study file.
This study is conducted based on the Declaration of Helsinki, Good Manufacturing Practice (GMP) for
medical devices, International Conference on Harmonisation Good Clinical Practice (ICH-GCP), applicable
laws and regulations in the People's Republic of China.
Based on ethical considerations, in accordance with ICH-GCP , relevant laws and regulations applicable
within the territory of the People's Republic of China, the design and implementation of this study put the
safety of subjects first on the requirements that the study medical device must be tested firstly when used
under clinical conditions. Therefore, in this pre-clinical study, the biological safety of the materials used is
tested firstly, and the purpose is to minimize the potential risks in the use of the materials. In order to
fundamentally elucidate safety issues, various criteria for this study are also identified.
13.2 Approval of Study Protocol
Before the clinical trial, the investigators should submit the study protocol, informed consent form and other
relevant documents to the medical ethics committee of the hospital where the study site is responsible for.
The clinical trial can only be initiated after obtaining the approval of the Ethics Committee. Any amendment
to the study protocol must be approved by the Ethics Committee before implementation. Serious adverse
events during the clinical trial should be reported to the Ethics Committee in written form in a timely manner.
13.3 Informed Consent Process and Informed Consent Form Text
Before each subject is enrolled in this study, the investigators are responsible for introducing the contents and
description of the informed consent form to him/her or his/her guardian completely and comprehensively in
written form.
The informed consent form should be written in a language understandable to the subject or his/her guardian.
The informed consent form shall contain no content that may cause the subject to give up his/her legal rights
and interests, and that exempt the clinical trial institution, the investigators, the sponsor or his/her agent from
taking the responsibilities.
Each subject must be given a written subject informed consent prior to enrollment. It is the responsibility of
the investigators to obtain informed consent before each subject enters the study and to retain it in the study
file.
For an incapacitated subject, if the Ethics Committee agrees in principle and the investigators believe that the
subject's participation in the clinical trial is in his/her own interests, he/she can also enter the clinical trial, but
his/her guardian should sign and date it before the trial.
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informed consent. After the informed consent form is explained in detail, the witness reads the informed
consent form, which shall be consistent with the oral informed consent. After the subject or his/her guardian
gives oral consent, the witness signs and dates the informed consent form, and the signature of the witness
shall be on the same day as that of the investigator.
See the Informed Consent Form for details.
13.4 Personal Data and Data Protection
(1) All data obtained in clinical trials are subject to data protection. The investigators should not disclose the
subject's name and other personal data (excluding date of birth/age and gender).
(2) The CRFs and other documents transmitted to the sponsor will not contain names, but only the study
code of the subject.
(3) Similarly, the data used for statistical evaluation can only be performed under the study code of the
subject. Only the investigator can identify the subject's name and other personal information through the
study code.
(4) During the study, if the subject name needs to be identified for medical reasons, all relevant personnel
are obligated to keep it confidential.
14. Provisions for Reporting Adverse Events and Device Defects
14.1 Adverse Event
14.1.1 Definition of adverse events
Adverse event (AE): refers to any adverse medical event occurring in the clinical trial process, no matter
whether it is related to the investigational medical device or not.
14.1.2 Adverse event grading
(1) Mild: Symptoms inquired.
(2) Medium: Symptoms that are actively described but can be tolerated.
(3) Severe: Intolerable symptoms with objective manifestations.
14.1.3 Reporting and handling of adverse events
All the adverse events and serious adverse events observed in the clinical trial should be clearly filled in the
adverse event column of case report form. The duration of adverse event (i.e., the date of occurrence and
disappearance of adverse event), severity, relationship with the clinical trial, and corresponding treatment and
other handling measures should be recorded. Subjects occurring such event shall be followed up to end of the
trial or the adverse event outcome.

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14.1.4 Correlation between adverse event and product
The correlation between all adverse events and study interventions must be judged by the investigators. The
investigators then assessed based on temporal relationship and clinical experience. The followings are the
evaluation criteria and judgment results of correlation:
1
The adverse event occurs within a reasonable time after the application of the device;
2
The adverse event can not be explained by other reasons;
3
The adverse event id relieved or disappeared after the the device is not applied;
4
The adverse event reappears after reapplication of the device.
Table 3. Correlation evaluation table
Standard
Results
①
②
③
④
Definitely related
+
+
+
+
Probably related
+
+
+
?
Possibly related
+
-
?
?
Unlikely related
-
-
?
?
Unrelated
-
-
-
-
"+" indicates conformity, "-" indicates non-conformity, "?" Indicates unable to judge
14.1.5 Handing protocol of adverse events that may occur in this clinical trial
(1) Anastomotic bleeding: It is related to the factors of anastomotic leakage. The bleeding is generally the
technical factor. The prevention is mainly to avoid the tension at the anastomotic stoma and the fat drop
left at the cutting site.
(2) Anastomotic leakage: The incidence of anastomotic leakage is reported to be 4% to 15% in the literature.
It may be caused by the stapler, or related to the patient's condition or the doctor's operation;
(3) Anastomotic stricture: It is one of the most common complications, mostly occurring after 1 month after
surgery.
(4) Major incisional bleeding: Drop in hemoglobin ≥20g/l resulting in ≥1 transfusion.
(5) Minor incision bleeding: Bleeding that does not meet the criteria for "severe bleeding".
(6) Incision site infection: Infection at the incision site due to improper nursing, resulting in prolonged
incision healing time, prolonged suture removal time, or unplanned antibiotic therapy.
(7) Delayed healing of incision: The incision in contact with suture has delayed healing time.
(8) Anemia and hypoproteinemia: Symptoms caused by tumor deterioration in patients with gastric cancer;
(9) Tumor recurrence or metastasis: Symptoms caused by further tumor deterioration in patients with gastric
cancer;

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(10)Gastrointestinal discomfort symptoms: Common symptoms of gastrointestinal diseases, such as nausea,
belching, constipation, diarrhea, acid reflux, abdominal pain, etc.
14.1.6 Handing of adverse events that may occur in this clinical trial
The above are foreseeable adverse events of this study. The investigators may treat adverse events according
to clinical diagnosis and treatment regulations as needed and record them faithfully.
14.2 Serious Adverse Event
14.2.1 Definition of serious adverse event
Serious adverse event refers to events occur in the process of clinical trial that causes death or serious
deterioration of health, including
(1) Fatal disease or injury;
(2) Permanent damage to the body structure or body function;
(3) Requiring hospitalization or prolonging the hospitalization
(4) Requiring medical or surgical intervention to avoid the permanent damage to the body structure or body
function;
(5) Any event that results in fetal distress, fetal death, or a congenital anomaly or birth defect.
14.2.2 Handling of serious adverse events
(1) In case of any serious adverse event in the clinical trial, the investigators should immediately take
appropriate therapeutic measures for the subjects, report to the management department of medical
device clinical trial of the clinical trial institution in written form, and notify the sponsor in written form.
(2) The management department of medical device clinical trial shall submit a written report to
corresponding ethics committee, food and drug regulatory authority, and health commission authority of
the local province, autonomous region or municipality directly under the central government where the
clinical trial institution is located within 24 hours.
(3) For death-typed events, the clinical trial institutions and investigators should provide all required data to
the ethics committee and the sponsor.
(4) For serious adverse events and device defects that may cause serious adverse events, the sponsor shall
report to the filed food and drug regulatory authority and the health commission authority at the same
level within 5 working days after being informed, notify other clinical trial institutions and investigators
participating in the trial, and timely notify the ethics committee of the clinical trial institution through its
medical device clinical trial management department.

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14.3 Reporting and Handling of Device Defects
Device defects refer to unreasonable risks that may endanger human health and life safety under normal use
of a medical device during a clinical trial, such as labeling errors, quality problems and failures, etc.
Possible device defects: identification error, product quality problem; design defect; damage of disinfection
package, etc.
All device defects are documented on the Device Defect Record form, and device defects that could have led
to serious adverse events shall be reported and documented within 5 working days.
15. Device Management
15.1 Study Device Management
Clinical trial institutions shall establish a strict registration system for the distribution of study devices. The
sponsor shall assign a special person to directly deliver the study medical devices and control medical
devices to each clinical trial institution. Clinical trial institutions and the sponsor shall establish perfect
device receiving formalities, and the records shall include the date, quantity, batch number and expiry date.
Each clinical trial institution uses a special Record Form for Use of Medical Devices in Clinical Trials to
register the name of the subject, date of use, and signature of the device administrator, etc.
15.2 Device Packaging
The external package and number of study medical devices shall be unified, and the number, name,
specification, course of treatment, production date, shelf life and the words "for clinical study only" shall be
indicated on the package.
15.3 Recovery of Remaining Device
Upon termination of the trial, the sponsor will collect all unused study medical devices and control medical
devices, and the sponsor is responsible for destroying the unused medical devices. All supplies must be
accounted for at the end of the study.
16. Deviations from Clinical Trial Protocol and Provision for Amendments to Clinical
Trial Protocol
16.1 Deviations from Clinical Trial Protocol
16.1.1 Definition of protocol deviation
Deviation refers to a situation where the requirements of the clinical trial protocol are not followed
intentionally or unintentionally.

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16.1.2 Deviation control measures
16.1.2.1 Sponsor
(1) The protocol shall be clearly described, and possible protocol deviations shall be considered. The
protocol shall be designed in a way to minimize the occurrence of protocol deviations, and possible
protocol deviations shall be simply and clearly identified and confirmed.
(2) In the investigator meeting and monitor training of the study project, the implementation details of the
protocol, and the reporting and monitoring of protocol deviations should be given intensive training.
(3) There is a special protocol deviation control group that regularly reviews the protocol deviation records
to identify potential trends and system errors; the correction of protocol deviation should be implemented.
If it is necessary to immediately amend the protocol or study plan, the study project should be suspended
in time, and the study can be continued after the protocol is amended and the retraining is completed.
16.1.2.2 Investigators
(1) At the project evaluation stage before the start of the study, the study protocol shall be read carefully, and
the enforceability of the protocol in the institution shall be fully discussed with the sponsor.
(2) The investigators are responsible to explain the importance of compliance with the protocol to the
subject at the time of informed consent.
(3) The investigators shall comply with the protocol approved by the Ethics Committee. In addition, the
occurrence of protocol deviation should be recorded and explained immediately when he/she recognizes
it.
16.1.3 Retraining
In the following cases, the investigators must receive re-training, and may receive multiple trainings if
necessary.
(1) There are deviations in the understanding of the protocol;
(2) There are new investigators participating in the trial;
(3) The study plan changes;
(4) The investigators are reminded of the protocol details.
16.1.4 Protocol deviation report
In case of any deviation from the clinical trial protocol that affects the rights, safety and health of the subjects
or the scientificity of the clinical trial, including the requested deviation and the reported deviation; the
investigators should timely report to the management department for medical device clinical trial of the
clinical trial institution, and timely notify the sponsor and the Ethics Committee to determine whether the

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trial can continue to be conducted.
In order to protect the rights, safety and health of subjects, where the deviation occurs in an emergency can
not be reported in a timely manner, it shall be reported in written form as soon as possible afterwards in
accordance with relevant regulations.
During the clinical trial, in case of revising the clinical trial protocol, informed consent form and other
documents, requesting for deviation and resuming the suspended clinical trial, the implementation can only
be continued after obtaining the written approval from the Ethics Committee.
The investigators should strictly follow the clinical trial protocol. Without the approval of the sponsor and the
Ethics Committee, or failing to obtain the approval from NMPA (original CFDA) as required, the
investigators should not deviate from the protocol or materially change the protocol. However, in the event of
an emergency that requires immediate removal, such as when the subject is at an immediate risk, a written
report may be made afterwards.
16.2 Amendments to Clinical Trial Protocol
Medical device study protocol should be based on the primary principle of protecting the rights, safety and
health of the subjects to the maximum extent. It should be jointly designed and formulated by the medical
institution responsible for the clinical trial and the sponsor, and should not be implemented until recognized
by the Ethics Committee; if the investigators have any revision to the study protocol, informed consent form
and case report form during the study, the clinical trial should not be continued until approved by the Ethics
Committee.
17. Direct Accessed Source Data/Source Documents
The authorized monitor has the right to access and verify the source data/documents of the subjects, so as to
judge whether the investigators conduct the clinical trial according to the requirements of the protocol, and
whether the source data/documents are timely recorded in the subject medical records. The monitor should
confirm that the source data/documents are traceable and verifiable. Meanwhile, the data filled in the CRF
should correspond to the source data/documents.
When any personnel participating in the clinical trial question the clinical trial data, the investigators shall
timely provide the source data/source documents for verification by relevant personnel and carefully reply to
the relevant queries.
Source data/documents should be properly kept in accordance with the requirements of relevant laws and
regulations. Prior to destruction, it shall be signed and confirmed by the sponsor, and comply with relevant
laws and regulations.
18. Finance and Insurance
The sponsor of this clinical trial is responsible for providing the investigational medical device and control

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medical device required by this clinical trial, and providing the inspection item cost required by this clinical
trial. The sponsor shall bear the treatment cost and corresponding economic compensation for the subjects
who suffer from injury or death related to the clinical trial, except for the damage caused by the faults of
medical institutions and their medical staff in the diagnosis and treatment.
The specific requirements for finance and insurance are detailed in the relevant agreements.
Medical accidents refer to accidents in which medical institutions and their medical staff violate the laws,
trial protocols and guidelines for medical and health management in medical activities, and negligence results
in personal damage to patients.
19. Contents Covered in Clinical Trial Report
The clinical trial report shall be prepared in accordance with relevant requirements of GCP and with
reference to Template for Clinical Trial Report of Medical Devices, including but not limited to:
(1) General information;
(2) Abstract;
(3) Introduction;
(4) Clinical trial purpose;
(5) Clinical trial method;
(6) Clinical trial content;
(7) General clinical data;
(8) Investigational medical device and control medical device or control diagnosis and treatment method;
(9) Statistical analysis method and evaluation method adopted;
(10)Clinical evaluation criteria;
(11)Organizational structure of clinical trial;
(12)Ethical statement;
(13)Clinical trial results;
(14)Adverse events identified in clinical trials and handling situations;
(15)Analysis
and
discussion
of
clinical
trial
results,
especially
indications,
applicable
scope,
contraindications and precautions;
(16)Clinical trial conclusion;
(17)Existing problems and suggestions for improvement;
(18)List of trial personnel;
(19)Other situations requiring explanation.
20. Confidentiality
The investigators must strictly keep confidential the study results, protocol and other data, and can not release

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them by themselves unless authorized by the sponsor in written form. If referenced, a written authorization
must also be obtained from the sponsor in advance.
All personal information of subjects is confidential. Besides relevant study personnel, only the sponsor, ethics
committee members and relevant national/local food and drug administration personnel related to this study
project can be allowed to access such information. The investigators and sponsor should keep the personal
information of the subjects confidential.
21. Agreement on Publication of Study Results
The sponsor and investigators shall agree with the final study report.
The results of the study may be made publicly available as scientific literature and the results may be
submitted to authorities. This clause is intended to protect trade secret materials.
All information about the study medical device (e.g., patent application, previously undisclosed
manufacturing process provided to the investigators by the sponsor, basic scientific data, etc.) is considered
confidential and its ownership belongs to the sponsor. The investigators may not use it for other purposes
without the written permission of the sponsor.
Prior to publication or presentation of the results of this study, the investigators allow the sponsor to review
the manuscript and comment within 30 days to confirm that the confidential information is not disclosed, and
to supplement the relevant information. According to the generally accepted principles of scientific
cooperation, the investigators should discuss the manuscript with the relevant personnel of the sponsor and
reach a consensus before the manuscript is published.
22. Responsibilities Assumed by Each Party
22.1 Responsibilities of Sponsor
(1) The sponsor is responsible for initiating, applying for, organizing and monitoring the clinical trial, and is
responsible for the authenticity and reliability of the clinical trial.
(2) The sponsor is responsible for organizing the development and revision of the investigator's brochure,
clinical trial protocol, informed consent form, case report form, relevant standard operating procedures
and other relevant documents, and organizing the training necessary for the clinical trial.
(3) Before signing the clinical trial agreement with the clinical trial institution, the sponsor shall provide the
clinical trial institution and investigators with the latest investigator's brochure and other relevant
documents for them to decide whether they can undertake the clinical trial.
(4) The sponsor shall not exaggerate the publicity of the mechanism and efficacy of the study medical device
in organizing the development of clinical trial protocol.
(5) During the clinical trial, when the sponsor obtains important information affecting the clinical trial, the
investigator's brochure and relevant documents shall be revised in a timely manner, and submitted to the

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ethics committee for review and approval through the medical device clinical trial management
department of the clinical trial institution.
(6) The sponsor shall reach a written agreement with the clinical trial institution and the investigators on the
detailed rules related to the clinical trial.
(7) The sponsor is responsible for the safety of the study medical device in the clinical trial.
(8) Where the sponsor decides to suspend or terminate the clinical trial, it shall notify the management
department of medical device clinical trial of all the clinical trial institutions within 5 days, and explain
the reasons in written form.
(9) The sponsor shall ensure that all investigators conducting clinical trials strictly follow the clinical trial
protocol, and timely point out and correct the clinical trial institutions and investigators who fail to
comply with relevant laws and regulations, this Practice and clinical trial protocol; if the situation is
serious or does not change continuously, the trial shall be terminated and reported to the food and drug
regulatory authority of the provinces, autonomous regions and municipalities directly under the central
government where the clinical trial institutions are located, as well as NMPA (original CFDA).
(10)The sponsor shall bear the treatment cost and corresponding economic compensation for the subjects
who suffer from injury or death related to the clinical trial, except for the damage caused by the faults of
medical institution and its medical staff in the diagnosis and treatment.
(11)The sponsor should bear the responsibility of monitoring and verifying the clinical trial.
(12)For serious adverse events and device defects that may cause serious adverse events, the sponsor shall
report to the food and drug regulatory authority which files the trial, as well as the health commission at
the same level within 5 working days after being informed. The sponsor shall notify other clinical trial
institutions and investigators participating in the trial, and timely notify the Ethics Committee of the
clinical trial institution through its medical device clinical trial management department.
(13)The sponsor shall ensure that the clinical data in the electronic clinical database or remote electronic
clinical data system are controlled and authentic, and form complete validation documents.
(14)The sponsor shall ensure that the CRFs are rigorously and rationally designed, so that the coordinating
investigators can obtain all data from the clinical trial institutions of each sub-site.
22.2 Responsibilities of Clinical Trial Institution and Investigators
(1) Before accepting a clinical trial, the clinical trial institution should evaluate relevant resources according
to the characteristics of the study medical device to determine whether to accept the clinical trial.
(2) The clinical trial institution should properly keep the clinical trial records and basic documents according
to the agreement with the sponsor.
(3) The investigators responsible for the clinical trial should have the corresponding qualification.

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(4) Before a clinical trial, the management department for clinical trial of medical device of the clinical trial
institution should cooperate with the sponsor in submitting an application to the Ethics Committee and
submitting the relevant documents as required.
(5) The investigators should ensure that relevant staff participating in the trial are familiar with the principles,
applicable scope, product performance, operation methods, installation requirements and technical
indicators of the study medical device; understand the pre-clinical study data and safety data of the study
medical device; and master the prevention and emergency treatment methods of possible risks in the
clinical trial.
(6) The investigators should ensure that the study medical device is only used for the subjects of the clinical
trial, and should not charge any fee.
(7) The investigators should strictly follow the clinical trial protocol. Without the approval of the sponsor
and the ethics committee, or failing to obtain the approval from NMPA (original CDFA) as required, the
investigators should not deviate from the protocol or materially change the protocol. However, in the
event of an emergency that requires immediate removal, such as when the subject is at an immediate risk,
a written report may be made afterwards.
(8) The investigator is responsible for recruiting the subject and communicating with the subject or his/her
guardian.
(9) The investigators or other personnel involved in the trial should not coerce or induce the subject to
participate in the trial in other improper ways.
(10)When the investigators find unexpected adverse events of the study medical device during the clinical
trial, they should modify the relevant contents of the informed consent form with the sponsor. After
reporting to the Ethics Committee for review and approval according to the relevant working procedures,
the affected subjects or their guardians should re-sign and confirm the revised informed consent form.
(11)The investigators shall be responsible for making medical decisions related to the clinical trial. In case of
any adverse event related to the clinical trial, the clinical trial institution and the investigators shall
ensure to provide adequate and timely treatment, as well as processing for the subjects.
(12)In case of any serious adverse event in the clinical trial, the investigators should immediately take
appropriate therapeutic measures for the subjects, report to the management department of medical
device clinical trial of the clinical trial institution in written form, and notify the sponsor in written form.
(13)The investigators should record all adverse events occur and device defects found during the clinical trial,
work with the sponsor to analyze the causes of the events, form a written analysis report, propose the
comments on continuing, suspending or terminating the trial, and report to the Ethics Committee by the
management department for clinical trial of medical device of the clinical trial institution for review.

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(14)The investigators should ensure that the clinical trial data are accurately, completely, clearly and timely
recorded in the CRF.
(15)The clinical trial institution and investigators shall ensure that the data, documents and records generated
from the clinical trial are authentic, accurate, clear and safe.
(16)The clinical trial institution and investigators should accept the monitoring and verification by the
sponsor, as well as the supervision by the Ethics Committee; and provide all required records related to
the trial.
(17)When the clinical trial institution and investigators need to suspend or terminate the clinical trial when
they find that the risks outweigh the possible benefits, or the results are enough to judge the safety and
effectiveness of the study medical device, they should inform the subjects and ensure that the subjects
receive appropriate treatment and follow-up, report according to the provisions, and provide a detailed
written explanation.
(18)The clinical trial institution and investigators shall report to the food and drug regulatory authority of the
province, autonomous region or municipality directly under the central government where the sponsor li
located if the sponsor violates relevant regulations or requirements to change the trial data and
conclusions.
(19)At the end of the clinical trial, the investigators should ensure the completion of various records and
reports, and timely deliver the required clinical data to the clinical trial institution as required.
(20)The investigators should provide relevant training for the authorized personnel, and form the
corresponding documents.
Note: See the "Clinical Trial Contract" and other relevant documents for the responsibilities assumed
by specific parties.
23. References
[1] Peng Junsheng, Song Hu, Yang Zuli, et al. Systematic Review of Laparoscopic-assisted Distal
Gastrectomy and Conventional Open Distal Gastrectomy for Early Gastric Cancer [J]. Cancer, 2010 (04):
381-387.
[2] Hu W G, Ma J J, Zang L, et al. Learning curve and long-term outcomes of laparoscopy-assisted
gastrectomy for gastric cancer [J]. J Laparoendosc Adv Surg Tech A, 2014, 24 (7): 487-492.
[3] Man-I M, Suda K, Kikuchi K, et al. Totally intracorporeal delta-shaped B-I anastomosis following
laparoscopic distal gastrectomy using the Tri-Staple reloads on the manual Ultra historical: a prospective
cohort study with distal controls [J]. Surg Endosc, 2015, 29 (11): 3304-3312.
[4] Jiang Xuefeng, Xiao Baolai, Hu Xiaomiao, et al. Effect of different anastomosis methods of Billroth II
anastomosis in laparoscopic radical gastrectomy for gastric cancer [J]. Chinese Journal of Operative

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Procedures of General Surgery (Electronic Edition), 2013 (04): 273-276.
[5] Han Chao, Lianchang Hong, Zhao Qiang, et al. Short-term efficacy analysis of total laparoscopic radical
gastrectomy for gastric cancer [J]. Chinese Journal of Operative Procedures of General Surgery (Electronic
Version), 2016 (02): 148-151.
[6] Forest. Modified triangular anastomosis for total laparoscopic distal gastric cancer [D]. Fujian Medical
University, 2014.
[7] Wang Yuxiang, Liang Wei, Zhu Zhiqiang, et al. Safety and short-term efficacy of total gastrectomy and
laparoscopic-assisted distal gastrectomy for gastric cancer [J]. Chinese Journal of Clinicians (Electronic
Edition), 2013 (20): 9360-9362.
[8] Cai Xun, Zhang Jianxin, Ma Dandan, et al. Application of triangular anastomosis in laparoscopic distal
gastrectomy for gastric cancer [J]. Chinese Journal of Minimally Invasive Surgery, 2014 (06): 494-497.
[9] High Wave. Application value of triangular anastomosis in total laparoscopic distal gastrectomy for
digestive tract reconstruction [D]. Shanxi Medical University, 2016.
[10] Tu Jiancheng, Fang Jian, Zhou Liang, etc. Application of Triangular Anastomosis in Laparoscopic
Distal Gastrectomy for Patients with Gastric Cancer [J]. Journal of Clinical and Experimental Medicine, 2015
(17): 1458-1460.
[11] Yuan Hong, Dai Feng, Wang Jiangping, et al. Feasibility analysis of gastroduodenal triangle
anastomosis in total laparoscopic distal gastrectomy for gastric cancer [J]. Journal of Laparoscopic Surgery,
2015 (10): 729-733.
[12] Steven A. Julious. Sample Sizes for Clinical Trials [M]. Chapman & Hall/CRC, 2010:96
[13] H.Frick, On Approximate and Exact Sample Sizes of Equivalence Test for Binomial Proportions [J],
Biometrical Journal, 1994, 841-854
24. Supplementary Provisions
Meanings of the academic terms involved in this study protocol:
Medical device clinical trial institution: it refers to the medical institution undertaking medical device
clinical trial recognized by NMPA (original CFDA) and NHFPC. Unless otherwise specified, "clinical trial
institution" in this protocol refers to "medical device clinical trial institution".
Investigational/study medical device: it refers to the medical device to be applied for registration whose
safety and effectiveness are confirmed or verified in the clinical trial.
Sponsor: it refers to the institution or organization initiating, managing and providing financial support for
the clinical trial.
Investigator: it refers to the person responsible for conducting the clinical trial in the clinical trial institution.
If a trial is conducted by a team of individuals at a clinical trial institution, the investigator is the responsible

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leader of that team, also known as the principal investigator.
Ethics Committee: it refers to an independent institution set by the clinical trial institution to review the
scientificity and ethicality of the medical device clinical trial project.
Management department of medical device clinical trial: it refers to the division or department set within
a clinical trial institution to be responsible for the organization management and quality control of the
medical device clinical trial.
Multi-center clinical trial: it refers to the clinical trial conducted in more than three (including three)
clinical trial institutions in accordance with the same clinical trial protocol.
Subject: it refers to an individual recruited for the clinical trial of a medical device.
Informed consent: it refers to the process that the subject voluntarily participates in the clinical trial after
being informed of all aspects of the clinical trial, as evidenced by the signed and dated informed consent
form.
Informed consent form: it refers to the supporting document for the subject voluntary participation in the
clinical trial.
Monitoring: it refers to the activities that the sponsor designates special personnel to evaluate and
investigate the clinical trial institution and investigator; verify, record and report the data during the clinical
trial so as to ensure that the clinical trial carried out can comply with the clinical trial protocol, standard
operating procedures, Good Clinical Practice for medical devices and relevant applicable regulatory
requirements.
Monitor: it refers to the special personnel assigned by the sponsor to monitor the medical device clinical trial
project.
Audit: it refers to a systematic and independent inspection of clinical trial-related activities and documents
organized by the sponsor to determine whether the implementation of such activities, recording, analysis and
reporting of data comply with the clinical trial protocol, standard operating procedures, Good Clinical
Practice for medical devices and relevant applicable regulatory requirements.
Auditor: it refers to the personnel entrusted by the sponsor to audit the medical device clinical trial project.
Inspection: it refers to supervision and management activities conducted by regulatory authorities on
relevant documents, facilities, records and other aspects of clinical trials
Inspector: it refers to the personnel assigned by regulatory authorities to inspect the medical device clinical
trial project.
Deviation: it refers to the situation where the requirements of the clinical trial protocol are not followed
intentionally or unintentionally.
Case report form: it refers to the document designed in accordance with the clinical trial protocol to record

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all the information and data of each subject obtained during the trial.
Endpoint: it refers to an indicator used to assess a clinical trial hypothesis.
Source data: it refers to all information in original records and their approved copies of clinical findings,
observations and other activities in a clinical trial that can be used for reconstruction and evaluation of the
clinical trial.
Source document: it refers to the printed, visible or electronic documents containing source data.
Adverse event: it refers to any adverse medical event occurring in the clinical trial process, no matter
whether it is related to the investigational medical device or not.
Serious adverse event: it refers to any adverse event that results in death or serious deterioration in the
health of the subject during the clinical trial, including a life-threatening illness or injury, a permanent
impairment of a body structure or a body function, in-patient hospitalization or prolongation of existing
hospitalization, medical or surgical intervention to prevent permanent impairment of a body structure or a
body function; results in fetal distress, fetal death, or a congenital abnormality or birth defect, etc.
Device defect: it refers to unreasonable risks that may endanger human health and life safety under normal
use of a medical device during a clinical trial, such as labeling errors, quality problems and failures, etc.
Standard operating procedure: it refers to the standard and detailed written procedure proposed to
effectively implement and complete each work in the clinical trial.
Clinical data: it refers to the safety and performance information obtained from the relevant literature or
clinical application of the medical device.

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Investigator Statement
I agree that:
1.
This clinical trial should be conducted in strict accordance with the Declaration of Helsinki, current laws
and regulations of China, and the requirements of the study protocol.
2.
All required data shall be recorded accurately on the case report form (CRF), and the clinical trial report
shall be completed on time.
3.
The investigational medical device is only used for this clinical trial. The receipt and use of the
investigational medical device will be completely and accurately recorded during the clinical trial, and
the records will be kept.
4.
The monitor, inspector and regulatory authority authorized or dispatched by the sponsor will be allowed
to monitor, verify and inspect the clinical trial.
5.
The terms of clinical trial contract/agreement signed by all parties shall be strictly performed.
I have read the clinical trial protocol, including the above statement, and I agree all contents above.
Comments of sponsor
Agree.
Signature (seal): Zhang Xinghua
Date: 2019.01.25
Comments of investigator
Agree.
Signature: Ni Qing
Date: 2019.01.31
Comments of medical device clinical trial institution
Agree.
Signature (seal):
Date: 2021.07.01