Prospective, Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trial Protocol for the Safety and Efficacy of Clinical Applications of the Endoscopic Instrument Control System
Phase: NA
Conditions: Gallstone, Cholecystitis
Sponsor: The Third Xiangya Hospital of Central South University

Clinical Trial Protocol 
TITLE: Prospective, Multicenter, Randomized, Single-blind, Parallel-controlled Clinical Trial 
Protocol for the Safety and Efficacy of Clinical Applications of the Endoscopic Instrument 
Control System 
PROTOCOL ID: SDWG-NST600S-CT 
DOCUMENT TYPE: Study protocol 
DATE: 2019-09-01 
SPONSOR: The Third Xiangya Hospital of Central South University 
COLLABORATOR: The Affiliated Hospital of Qingdao University 
 
 

Study protocol 
1. Study purpose 
To evaluate the safety and efficacy of the MicroHand S endoscopic instrument control system 
by using it in clinical treatment for the participants. Statistical analysis is conducted to 
determine whether the efficacy of the test product is non-inferior to that of the control product 
and to observe the incidence of organ and vascular injury related to the test product. Thus, 
to verify the safety and efficacy of the MicroHand S endoscopic instrument control system 
developed by WEGO Surgical Robot Co., Ltd in clinical application. 
2. Content 
This clinical trial is a prospective, multicenter, randomized, single-blind, parallel-controlled 
study. The instrument used in the experimental group is the endoscopic surgical robotic 
system developed by WEGO Surgical Robot Co., Ltd., and the instrument used in the control 
group is the endoscopic surgical robotic system developed by Intuitive Surgical.  
Before patients are enrolled in this clinical study, the researchers will do a detailed 
screening of the subjects based on the inclusion and exclusion criteria to determine if the 
patients are appropriate for the clinical study. Patients who meet the conditions of the study 
will be required to sign an informed consent form. Then they will be randomly assigned to the 
test group or the control group. The surgical robot system will be used for treatment in both 
groups to evaluate the primary and secondary outcome measures and to observe the 
incidence of organ and vascular injury.  
Finally, we evaluate the safety and efficacy of the test product through the comparison of 
the data obtained from the test group and the control group during the treatment. 
3. Background 
The development direction of medical treatment in the 21st century is to preserve the 
physiological structure and function of patients as much as possible. Compared with 
conventional laparotomy, minimally invasive surgery has obvious advantages in terms of 
treatment effect, pain relief, recovery, and medical cost. The endoscopic instrument control 
system, also known as the surgical robot, is a breakthrough in the field of surgery, which 
greatly expands the indications of minimally invasive surgery. 
The endoscopic instrument control system has the characteristics of minimally invasive 
surgery and more technical advantages:  
(1). It can accurately simulate the movements of human hands, wrists and fingers with multi-
degree of freedom.  
(2). It can proportionally reduce the surgeon's range of motion and improve the accuracy of 
surgical procedures. 
(3).The tremor filtering system filters the hand vibration of the surgeon and improves the 

stability of the operation. 
(4).The imaging system provides the surgeons with a three-dimensional magnifying view (5 
to 10 times) of the field image to enhance the surgeon's visual perception. 
(5). Using a surgical robot, the surgeon can sit in a comfortable chair so that they can relieve 
the operator's fatigue, reduce the probability of making mistakes due to tiredness, and 
improve the safety of the operation. 
(6). The surgeons can use the "high-speed broadband" technology to interface with other 
digital devices and to control the surgical robot for a surgery.  
From 2000 to the present, the "Da Vinci" robotic system has become the most commonly 
used robotic surgical system because of its superior design and performance. Since its 
inception, the system has been used in a variety of operations including cardiac surgery, 
general surgery, gynecology, head and neck surgery, thoracic surgery and urology.  
As of October 2018, more than 4,000 systems were in use worldwide, with more than 5 
million patients benefiting from the advanced minimally invasive techniques of da Vinci 
surgical robot. But its high cost, expensive annual maintenance cost, and accessory 
instruments limit the use of da Vinci's surgical systems in developing countries like China. 
The endoscopic surgical robotic system developed by WEGO Surgical Robot Co., Ltd. is 
a minimally invasive surgical robotic system independently developed by China which is the 
first successful minimally invasive surgical robotic system in China with property rights. It can 
complete complex suture and knotting, replace the traditional planar imaging system with a 
three-dimensional stereo vision system to make the surgical field clearer. The adjustable 
mapping ratio and more practical energy device are its unique specialty. It can also greatly 
reduce the cost of robotic surgery.  
The test product has passed the test of Beijing Medical Device Quality Supervision and 
Inspection Center of the China Food and Drug Administration. All met the standard 
requirements and issued qualified registration inspection. The clinical verification will be 
performed by the Third Xiangya Hospital of Central South University and the affiliated hospital 
of Qingdao University, to prove the safety and efficacy of this product. 
4. Precautions of the test product 
1. Please read the user manual and instructions carefully before using the console. 
 2. Operators are required to have certain qualifications. They are required for more than 5 
years of experience in laparoscopic surgery, more than 1 year of experience in robotic surgery, 
and having been trained to operate the test product skillfully. 
 3. Before each operation, you must check whether the console is damaged, whether the 
control panel displays normal, and whether the connecting wires and interfaces are integrated. 
 4. After turning on the power, you shouldn’t operate until the console completely starts and 
the operative arms and other surgical preparations are prepared. 
 5. The operation should be meticulous and gentle, avoiding excessive and violent 
movements to cause damage to subjects or instruments. 
 6. Emergency preparation for accidents must be done before surgery. 
 7. Disconnection is prohibited during the operation. 
 8. Do not embed any foreign components. Any foreign components embedded can cause 

permanent damage to the product. If it does, immediately turn off the power and contact a 
qualified service person for repairing. 
 9. Do not attempt to disassemble or modify the product. 
 10. The console should be placed in a clean, dry, suitable temperature and humidity 
environment, having regular inspection and maintenance. 
 11. If the console has any malfunction, stop the procedure and report it to the manufacturer 
in time. 
5. Study Methods  
(1) This study uses a multicenter, randomized, single-blind, parallel-controlled method to 
observe the efficacy and safety of the MicroHand S endoscopic instrument control system 
in clinical application.  
(2) The subjects' vital signs are recorded before the start of this study, which include blood 
routine, liver and kidney function, electrolytes, coagulation function, electrocardiogram, 
urine/blood pregnancy test (female) and related imaging examination. Preoperative 
combined medications are also recorded. 
(3) Qualified subjects are divided into the experimental group and the control group by 
randomized number given in an envelope. Both the endoscopic instrument control 
systems in two groups are examined before the test. After anesthesia, the endoscopic 
instrument control system is placed in an appropriate position. Then we connect the wires 
and power up the system. According to the requirements of the surgery, the operative 
arms are placed and slowly pushed through the Trocars of the abdominal wall. The 
surgeons start to perform the operation. 
(4) Surgical success rate, intraoperative blood loss, operative time, and installation time are 
recorded, as well as whether adjacent organs and blood vessels are injured due to the 
malfunction of the test system. The breakage rate of gallbladders is calculated. Surgeons 
need to fill the satisfaction questionnaire after the surgery. 
(5) Subjects take a test in 24 ± 2 hours after surgery using visual analogue scale (VAS) to 
evaluate the pain score. Postoperative blood routine examination, liver and kidney 
function, and electrolyte examination are performed. Time to first flatus, postoperative 
complications and hospital stay are recorded. Postoperative combined medications are 
also recorded.  Adverse events and severe adverse events are assessed separately in 
30±5 days after surgery.  
(6) After the follow-ups of all subjects, the data will be arranged for statistical analysis. 
Ultimately the data of the two groups will be compared, so as to prove whether the 
experimental product developed by WEGO Surgical Robot Co., Ltd is non-inferior to the 
control group. 
 
6. Arms and Interventions 
(1) Experimental group: MicroHand S endoscopic instrument control system  
Using the MicroHand S endoscopic instrument control system to treat gallstone or 
cholecystitis in minimal invasive surgery. 

 
(2) Control group: da Vinci endoscopic instrument control system 
Using the da Vinci endoscopic instrument control system to treat gallstone or cholecystitis in 
minimal invasive surgery. 
 
7. Subject recruitment 
7.1  Inclusion criteria 
(1) 18-65 years old, male or female 
(2) American Society of Anesthesiologists (ASA) Level 1, Level 2 or Level 3 
(3) BMI 18-30Kg/m2 
(4) Benign gallbladder diseases such as acute or chronic cholecystitis, gallstones and 
polypoid lesions of gallbladder 
(5) Subjects or their legal representatives/guardians voluntarily participate in clinical trials and 
have signed informed consent 
 
7.2  Exclusion criteria 
(1) Participating in any other clinical trial within 30 days before signing the informed consent 
form 
(2) Pregnancy or lactation 
(3) With a history of epilepsy or psychosis 
(4) With a history of previous operations at related sites 
(5) Severe cardiovascular and cerebrovascular diseases with New York grade III-IV cardiac 
function or pulmonary insufficiency that can’t tolerate the operation 
(6) Severe liver and kidney insufficiency such as cirrhosis and renal failure 
(7) Acute cholecystitis lasting for more than 72 hours, acute cholecystitis with severe 
complications such as cholecystitis, gangrene, perforation, etc., and gallbladder thickness 
thicker than 10 mm 
(8) Acute cholangitis, gallstone with acute pancreatitis, primary common bile duct stones, 
intrahepatic bile duct stones and obstructive jaundice 
(9) Gallbladder cancer or protuberant lesions are suspected to be cancerous 
(10) Severe allergic constitution and suspected or identified addicts to alcohol or drugs 
(11) Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or 
metastatic diseases 
(12) Other situations that researchers consider it inappropriate to participate in this clinical 
trial 
 
7.3  Inclusion time 
After signing the informed consent, subjects who meet the inclusion criteria and do not 
meet the exclusion criteria can be enrolled within 14 days. It is expected to take 12 months 
from the first case to the last case. 
 
7.4  The expected duration of the study 
The expected duration time of each subject is 33 days. Considering that the robotic 

surgery has not been widely carried out in China, as well as the poor subject compliance, the 
overall duration of this clinical trial is expected to be 13 months. 
 
7.5  The expected duration time of each subject 
Each subject is observed up to 30 days after surgery, and efficacy and safety are 
evaluated at the end of the follow-up. So the expected duration of each subjects is 33 days. 
The additional 3 days are used for preoperative examination. 
 
7.6  Number of subjects required 
In this clinical trial, 168 patients are enrolled, including 84 in the experimental group and 
84 in the control group. 
 
7.7  Drop-outs and removal of the subjects 
All subjects who sign the informed consent form and participate in the study, whenever 
they withdraw from the study for any reason, as long as they do not complete the observation 
period specified in the protocol, they are shedding cases. Usually in these situations: 
(1) The subject or his/her legal guardian requests to withdraw from the clinical trial. 
(2) Adverse events (AE), severe adverse events (SAE), or any device defects that prevent 
subjects from continuing to participate in the study. 
(3) The researchers consider it medically necessary for the subjects to terminate the study. 
(4) Other reasons for subjects to suspend the study. 
When the subject drops out, the researcher should take various methods, such as paying 
a visit, making a follow-up appointment, phone call, letter, etc., to contact the subject as far 
as possible and ask the reason. Any drop-out due to adverse events should be recorded in 
the CRF form and notified to the sponsor, regardless of whether there is a causal relationship 
with the test product or not. All subjects enrolled in the study should retain various original 
data and documents, both for retention and for intentional analysis (ITT Analysis). 
All subjects meeting the following criteria should be removed: 
(1) Those found to violate the inclusion criteria or meet the exclusion criteria during the trial. 
(2) Withdrawing the informed consent. 
(3) The informed consent form is not signed or there is no informed consent process. 
(4) Failing to obtain observation data. 
Case removal is one of the key indicators to determine the endpoint data set of clinical 
trials. If there is a condition that affects the treatment or safety evaluation of the case, such 
as unavailable observational data, the case should be considered as not included in the 
analysis set. It must be decided after discussion between the principal investigator, the data 
manager, the statistical analyst and the sponsor. 
 
8.  Efficacy evaluation 
8.1  Primary outcome measure: surgical success rate 
The surgical success rate is defined as the proportion of successfully operative subjects 
in the experimental group or the control group. 
Surgery conversion in this study means a robotic surgery has to be converted to a 

laparoscopic surgery. Usually there are 3 kinds of reasons: active conversion, passive 
conversion and malfunction of the endoscopic instrument control system. 
(1) Active conversion: 
During the surgery, surgeons may encounter some situations that make them impossible 
to keep the operation going such as severe adhesion, anatomical variation or failing to 
expose the surgical site. Or when surgeons are dissociating the tissue, they have difficulties 
to find certain important vascular structure and to make a normal anatomy of the clearance. 
At this point, surgeons initiatively decide to convert to a laparoscopic surgery. 
(2) Passive conversion: 
During the surgery, some unexpected accidents happen and surgeons have to convert to 
laparoscopic surgery. Usually these accidents include injury of tissues and organs, 
unstoppable bleeding, and difficult suture using the surgical robot. Passive conversion is 
related to surgical techniques of the surgeons. With the experience accumulating and the 
operative skill improving of surgeons, the passive conversion rate will decrease significantly. 
(3) Malfunction of the endoscopic instrument control system: 
Serious malfunction of the test product may occur during the surgery (such as strong 
interference between the console and the operative part, the operative arm dysfunction and 
can’t be repaired by resetting, surgical instrument can't loosen the tissue, etc.) The operation 
is unable to continue, so surgeons have to convert to laparoscopic surgery. Usually the 
malfunction is caused by unreasonable design, unqualified instruments or inappropriate 
operation of the product arms. It indicates the deficiency of the test product. 
Notes:  
1) Surgical success is defined as the successful completion of all surgical operations through 
the experimental products or the control products.  
2) Surgical failure is defined as the unaccomplishable surgical operations using the 
experimental or control products as planned. The reason includes passive conversion and 
malfunction of the products. Noticeably, active conversion does not mean a surgical failure. 
 
8.2 Secondary outcome measures: 
(1) The breakage rate of gallbladder: 
The breakage rate of gallbladder is defined as the proportion of the subjects in the 
experimental group or the control group with specimen breakage.  
(2) Comprehensive Complication Index (CCI) 
CCI is calculated using online tools provided by http://cci.assessurgery.com. Based on the 
Clavien-Dindo complications grade system (appendix.1), all complications and adverse 
events after surgical intervention are taken into consideration. The overall incidence is 
measured on a scale ranging from 0 (no complication) to 100 (death). 
(3) Operative time (min) 
The length of time from the beginning of the operation after the robot installation to the end 
of the suture of the incision. 
(4) Intraoperative bleeding (L) 
The total bleeding volume from the beginning of the operation to the end of the suture of the 
incision. It can be calculated by measuring the blood volume in the vacuum suction device 
and weighing the gauze after using them to wipe the bleeding. 

(5) Postoperative pain 
Postoperative pain is assessed by visual analogue scale (VAS) 24-26 hours after the 
operation, ranging from 0 (no pain) to 10 (maximum pain). 
(6) Time to first flatus (h) 
The time from the end of the operation to the subject’s first flatus after surgery.  
(7) Surgeon’s satisfaction  
After the operation, surgeons fill a questionnaire to score the flexibility, intuition and stability 
of the products, as well as their sense of delay and fatigue when using the products. Each 
question in the score ranges from 1 to 5 points and the total score is 100. 
(8) Installation time (min) 
The time from the power-on of the products to the end of the connection between trocars and 
the operative arms. 
(9) Hospital stay (days) 
The total hospital days of subjects from admission to discharge. 
 
8.3 Selection criteria of surgeons 
In order to strictly guarantee the homogeneity of the surgeons, they need to meet a certain 
standard. Generally, they are required to have more than 5 years of endoscopic surgery 
experience and more than 1 year of robotic surgery experience, and have passed the test 
product training and obtained the operation training certification. 
 
9.  Safety evaluation 
9.1  Safety evaluation indicators: 
(1) The incidence of organ and vascular injury events which include the following: 
1) Any damage to the adjacent organs (liver, spleen and intestine) due to the malfunction 
of the products. 
2) The blood vessel injury caused by the malfunction of the products during the operation 
resulting in massive bleeding. 
(2) The incidence of adverse events from the end of the operation to discharge. 
(3) The incidence of the malfunction of the products which includes the following: 
1) The connection between the console and the operative arms receives strong 
interference, which cannot be solved by resetting. 
2) The tissue cannot be loosened when the surgical instrument is clamped. 
3) Device installation false alarm. 
4) Failure or damage of the surgical instruments during an operation. 
(4) Vital signs: temperature, heart rate, respiration, and mean arterial pressure. 
(5) Laboratory examinations: blood routine, liver and kidney function, and electrolytes. 
 
9.2  Indicators measurement methods  
(1) Vital signs: Twice a day before surgery, twice at the beginning and end of the operation, 
and twice at 3-5 days after the operation. Six times in total. 
(2) Laboratory examination: once before the operation and once within 3~5 days after the 
operation. At least twice in total. 

 
10.  Procedures 
10.1 
Records needed before starting 
(1) Basic information of subjects: the gender, height, weight and vital signs, etc. 
(2) Medical history: course of disease, severity of illness, medication, and previous surgical 
history. 
(3) Informed consent form. 
(4) Electrocardiogram. 
(5) The imaging examination: color ultrasound of liver, bile, pancreas and spleen and 
electronic gastroscopy. For subjects who are more than 50 years old, heart ultrasound 
and neck vascular ultrasound are needed. 
(6) Laboratory examinations: blood routine, liver and kidney function, coagulation function 
and electrolytes. 
 
10.2 
Standard operating procedures 
(1) Examining the console: appearance inspection, instrument performance, screen display 
and technical index. 
(2) Examining the operative arms: appearance inspection, movements, instrument 
performance, and technical index. 
(3) Connecting the endoscopic instrument control system and preparing the initialization of 
the system for a few seconds. 
(4) Starting the operation: anesthesia, position adjustment, pneumoperitoneum, setting 
trocars, and 3D laparoscopic light source. 
(5) Brief procedures of the operation: 
1) The surgeons control the operative arms to grab the neck of the gallbladder or 
Hartmann’s fossa with the bipolar electric knife and pull it to the upper right.  
2) The surgeons use the electric hook to dissociate the serosal membrane of gallbladder 
tube, make blunt dissection of gallbladder tube and gallbladder artery, and pay 
attention to distinguish common bile duct and common hepatic duct.  
3) The surgeons use hemo-lok clips to clamp the tube as close as possible to the neck 
of the gallbladder, and cut with surgical scissor between two hemo-lok clips.  
4) The surgeons clamp the neck of the gallbladder and pull upward. Simultaneously, we 
use ultrasonic knife to carefully detach along the gallbladder wall. The assistant should 
pull gently to hold the tension between the gallbladder and liver, which makes it easier 
to detach.  
5) After fully dissociation of the gallbladder, the surgeons take it out of the abdominal 
cavity through the 12mm trocar. Then we check if there is any bleeding or leakage 
before withdrawing orderly. 
6) The surgeons suture the surface wounds and turn down the products.