Effect of Simplified Robot (FASTER) Assisted Versus Conventional Endoscopic Submucosal Dissection (ESD) for Colorectal Lesions: A Prospective, Randomized, Controlled Trial
Phase: NA
Conditions: Colorectal Lesions, Endoscopic Submucosal Dissection (ESD), FASTER Robot
Sponsor: Kaiyun Liu

 
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Coil 
 
Interventional Clinical Study 
 
Efficacy of Simplified Robot (FASTER)–
Assisted Versus Conventional Endoscopic 
Submucosal Dissection (ESD) for Colorectal 
Lesions: A Prospective, Randomized, 
Controlled Trial 
Protocol 
 
 
 
Study Institution: Shenzhen Hospital of Southern Medical 
University 
Principal Investigator: Wei Gong 
Department: Gastroenterology 
Lead Site: Shenzhen Hospital of Southern Medical University 
NCT number：NYSZYYEC2025K111R002 
Version Date: October 11, 2025 
 
 
 

 
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Compliance Statement 
In compliance with the Measures for Ethical Review of Life Science and Medical Research Involving 
Humans and the (Interim) Measures for the Administration of Investigator-Initiated Clinical Research 
Conducted by Medical and Health Institutions, as well as the Declaration of Helsinki, we undertake to 
conduct this study in accordance with this protocol. All study personnel must receive training, and the 
study may be implemented only after written approval by the Ethics Committee and written informed 
consent from participants have been obtained. Any protocol amendments must be re-reviewed and 
approved. 
 
P R O T O C O L  S U M M A R Y 
Study design 
(multiple 
selections 
allowed) 
□ Case-control study      □ Cohort study      □ Cross-sectional study 
☑Randomized controlled trial      ☑ Blinding applied      □ Other: 
Study category 
(please tick 
according to 
project type) 
(Category A: High risk) 
□ Gene-editing research 
□ Cell therapy research 
□ Implantable medical device research (including 3D printing) 
□ Class III new clinical technologies (proven safety and effectiveness; high technical 
difficulty and high risk) 
□ Research in special populations (children, pregnant women, persons with 
intellectual disability, patients with mental disorders, etc.) 
□ Off-label drug research (□ beyond indication □ beyond route □ beyond dose □ 
beyond age □ beyond contraindications □ beyond 
population □ other, specify: 

 
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) 
□ Off-label device research (□ beyond indication □ beyond scope of use □ beyond 
contraindications □ beyond population □ other, specify: 
) 
□ Other (as judged by the investigator, 
specify:                              ) 
(Category B: Moderate risk) 
□ Post-marketing biologics research (preventive or therapeutic biologics) 
□ Post-marketing therapeutic vaccine research 
□ Post-marketing orphan drug research 
□ Class II new clinical technologies (proven safety and effectiveness; certain 
technical difficulty; with certain medical and ethical risks) 
□ Other (as judged by the investigator, 
specify:                              ) 
(Category C: Low risk) 
□ Research on drugs marketed for ≥5 years (including chemical drugs, generics, 
etc.) 
□ Research on marketed medical devices (including AI, imaging software, etc.) 
☑Class I new clinical technologies (proven safety and effectiveness; low technical 
difficulty; virtually no ethical risk) 
□ Wearable devices (proven safety and effectiveness; low technical difficulty; 
virtually no ethical risk) 
□ Other (as judged by the investigator, 
specify:                              ) 
□ Wearable devices (confirmed safety and effectiveness; low technical difficulty; 
almost no ethical risk) 
□ Other (as judged by the investigator, 
specify:                              ) 
Total number 
of cases 
40 cases 

 
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Risk/benefit 
analysis 
This study involves a relatively low level of risk. Potential risks include 
procedure-related complications such as gastrointestinal perforation, major 
bleeding, and infection, as well as device-related adverse reactions. We 
have established strict screening criteria and standardized operating 
procedures, and formulated emergency plans and postoperative follow-up 
to mitigate these risks. Meanwhile, this study may improve therapeutic 
outcomes for patients with colorectal lesions, shorten procedure time, and 
optimize the clinical workflow, providing scientific evidence for medical 
device development and medical progress. 
Risk 
assessment 
☑Not greater than minimal risk   □ Greater than minimal risk 
Minimal risk: the probability and magnitude of anticipated harm or discomfort in the 
study are not greater than those ordinarily encountered in daily life, or during routine 
physical examination or psychological tests. 
 
 
I. Background 
Colorectal cancer is one of the leading malignancies worldwide in both incidence 
and mortality. In 2022, approximately 1.9 million new cases were diagnosed globally 
and about 904,000 patients died. Although historically higher in developed countries, 
incidence has continued to rise in Eastern Europe, Southeast Asia, and South America 
with economic transition and lifestyle changes. This trend is mainly attributed to dietary 
changes, sedentary behavior, and the increasing prevalence of obesity [1]. Therefore, 
early screening and precise treatment are of great importance for improving patient 
outcomes. 
Endoscopic submucosal dissection (ESD) has been widely applied to treat 
superficial lesions of the gastrointestinal tract and is recommended by the European 
Society of Gastrointestinal Endoscopy (ESGE) for en bloc resection of colorectal 
lesions to ensure accurate pathological assessment and reduce the risk of local 
recurrence [2]. However, colorectal ESD still faces substantial anatomical and technical 
challenges. The right colon has a thin wall and is susceptible to tension; the transverse 
colon has sharp angulation and poor suspension; and the rectum is constrained by pelvic 
structures, resulting in a narrow operating space—factors considered high risk for 
perforation and muscular injury [3]. In addition, limited visualization of the submucosal 
layer and uneven tension distribution can prolong procedure time and increase 
complication risk [4]. Common traction techniques (e.g., clip-with-line, pulley, and 

 
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magnetic anchoring) can improve visualization to some extent, but most provide only 
unidirectional traction, require repeated repositioning, or rely on dedicated equipment, 
and thus do not meet the multidirectional traction needs of complex lesions [4]. 
Therefore, developing an assistive device that provides adjustable multidirectional 
traction and is compatible with a single-channel endoscope—thereby optimizing 
exposure and dissection efficiency while reducing complications—has become a key 
direction in the evolution of colorectal ESD. 
In recent years, robotic-assistance has gradually been applied in minimally 
invasive gastrointestinal therapy, particularly in laparoscopic surgery (e.g., the da Vinci 
Surgical System), where high-precision operation has been shown to improve 
procedural stability and surgeon control [5]. In the endoscopic field, systems such as 
the Master robot and STRAS have been used to enhance visualization and 
intraoperative precision [6, 7]. However, barriers related to cost and device 
compatibility remain, limiting widespread adoption. 
FASTER is a simplified robotic endoscopic assistive system designed to provide 
continuous, adjustable, multidirectional traction during ESD, thereby improving 
visualization and procedural efficiency. Unlike conventional traction methods, 
FASTER can be used with standard single-channel endoscopes and does not require 
specialized platforms. In an ex vivo porcine stomach model, Yang Xiaoxiao et al. 
conducted a crossover study comparing FASTER-assisted ESD with conventional ESD 
and found that total procedure time for beginners was significantly shorter in the 
FASTER group (25.6 ± 7.8 min) than in the conventional group (38.9 ± 13.4 min; P < 
0.001), while maintaining comparable safety and resection quality. 
Nevertheless, robust clinical evidence on the safety and effectiveness of FASTER 
in real-world colorectal ESD is still lacking. Given the unique anatomical complexity 
of the colon and rectum and the higher technical demands of colorectal ESD, a 
prospective randomized controlled trial is warranted to systematically evaluate whether 
FASTER can shorten procedure time, improve efficiency, and reduce complications in 
colorectal lesions. 
 
II. Objectives 
1. Primary objective: To evaluate whether FASTER-assisted ESD reduces total 
ESD procedure time compared with conventional ESD for colorectal lesions. 
2. Secondary objectives: To compare between the two groups (1) mucosal 
dissection time; (2) dissection speed; (3) R0 resection rate; (4) en bloc resection rate; 

 
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(5) complication rates 
(bleeding, 
perforation, muscular injury); 
and (6) 
flexibility/operability indicators of robotic manipulation. 
 
III. Endpoints 
1. Primary endpoint: Total ESD procedure time (min), defined as the cumulative 
time from submucosal injection to completion of submucosal dissection. 
2. Secondary endpoints: (1) Mucosal dissection time (min); (2) Dissection speed 
(mm²/min); (3) R0 resection rate; (4) en bloc resection rate; (5) Incidence of ESD-
related complications (bleeding, perforation, muscular injury); (6) Robotic flexibility 
indicators (number of attempts needed for a first successful grasp and the number of 
accidental drops). 
3. Safety endpoints: Device-related and procedure-related adverse events, 
including bleeding, perforation, muscular injury, infection, anesthesia-related events, 
and other unexpected events. 
 
IV. Study Design, Methods, and Procedures 
1. Study design 
This is a single-center, prospective, randomized, controlled, open-label clinical 
study. A total of 40 eligible patients scheduled for colorectal ESD will be enrolled and 
randomized 1:1 to a FASTER-assisted ESD group (intervention group) or a 
conventional ESD group (control group). 
Intervention group: During ESD, the endoscopist will attach the FASTER robotic 
arm to the tip of the endoscope. After submucosal injection and circumferential incision, 
the robotic grasper will provide continuous multidirectional traction on the lesion 
margin to optimize exposure and facilitate submucosal dissection. 
Control group: A transparent distal cap will be attached to the endoscope tip. The 
lesion will be treated with conventional ESD following standard steps without robotic 
assistance. 
All participants will be followed up during hospitalization, with daily assessments 
of vital signs, laboratory parameters, and adverse events until discharge. 
2. Study methods 
(1) Randomization 
A random number table method will be used for 1:1 allocation. An independent 
statistician will generate the random sequence. Allocation will be concealed until 
enrollment to ensure scientific rigor and fairness. 

 
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After randomization, the intervention group will undergo FASTER-assisted ESD 
and the control group will undergo conventional ESD. The study coordinator will 
implement allocation according to the concealed sequence. 
(2) Blinding/Unblinding 
Given the nature of the intervention, blinding of operators is not feasible. Data 
analysts may be kept blinded to group allocation when appropriate. Unblinding, if 
needed for safety reasons, will be documented with reason and time. 
 
3. Study procedures 
Study flow chart 
Item 
Screening period 
Procedure day 
Follow-up period 
-3 to 0 days 
Intraoperative 
During hospitalization 
Informed consent 
X 
 
 
 
Demographics 
X 
 
 
 
Inclusion/exclusion 
criteria 
X 
 
 
 
Laboratory tests 
X 
 
 
 
Electrocardiogram 
X 
 
 
 
Colonoscopy 
X 
 
 
 
Blood pressure, 
heart rate 
X 
X 
 
 
ESD procedural 
metrics 
 
X 
 
 
Adverse events 
 
X 
X 
X 
(Note: Laboratory test results should be within 7 days prior to signing informed consent; 
colonoscopy results should be within 6 months prior to signing informed consent.) 
 
V. Study Population 

 
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According to the 2019 guidelines of the Japan Gastroenterological Endoscopy 
Society (JGES), colorectal lesions meeting ESD indications will be included. 
1. Inclusion criteria 
(1) Age between 18 and 80 years.  
(2) Patients with colorectal lesions scheduled to undergo endoscopic submucosal 
dissection (ESD) . 
(3) Lesion characteristics meeting any of the following criteria: (1) Lesions 
unsuitable for en bloc resection using snare-based EMR, including non-granular type 
laterally spreading tumors (LST-NG), especially pseudo-depressed subtype (PD); 
lesions with type VI pit pattern (VI-type glandular opening configuration); carcinomas 
with superficial submucosal invasion (T1-SM); large depressed-type tumors; large 
protruding lesions suspected of malignancy, including nodular mixed-type granular 
LSTs (LST-G); other lesions unsuitable for en bloc resection using snare-based EMR; 
(2) Lesions with special background conditions, including mucosal tumors with 
submucosal fibrosis (caused by prior biopsy or mucosal prolapse due to peristalsis); 
sporadic tumors arising in the context of chronic inflammation (e.g., ulcerative colitis); 
local residual or recurrent early carcinoma following prior endoscopic resection;  
(4) Willingness to participate in the study and provision of written informed consent. 
2. Exclusion criteria 
(1)  Suspected deep submucosal invasive carcinoma based on endoscopic features；
(2)  Lesions presenting with non-lifting signs, suggesting deep submucosal invasive 
carcinoma or tumors with severe submucosal fibrosis;  
(3) Lesions extending to the appendiceal orifice, colonic diverticulum, or ileocecal 
valve;  
(4) Pregnant women or women who may be pregnant; lactating women;  
(5)  Patients with coagulation disorders; 

 
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(6)  Patients considered ineligible for specific reasons;  
(7) Patients with contraindications to anesthesia and/or colonoscopy. 
3. Lifestyle precautions 
1. Smoking: Reduce or quit smoking to avoid impairment of intestinal mucosal 
microcirculation, delayed wound healing, and to reduce the risks of postoperative 
bleeding and perforation. 2. Alcohol: Avoid spirits and high-alcohol beverages to reduce 
chemical irritation to the intestinal mucosa and potential effects on coagulation. 3. 
Exercise: Begin ambulation early after surgery to promote gastrointestinal recovery; 
avoid vigorous exercise such as running, jumping, and weightlifting; low-intensity 
activities such as walking and yoga are allowed. 4. Diet: Avoid high-fiber, high-fat, 
spicy foods and carbonated drinks. Within 2 weeks after surgery, a lukewarm liquid or 
semi-liquid diet is recommended; gradually resume a regular diet after 2 weeks. 5. 
Prohibited medications: Avoid NSAIDs, antiplatelet agents, and anticoagulants; if use 
is necessary, notify the study team for evaluation. Proton pump inhibitors (PPIs) may 
be used postoperatively to prevent delayed bleeding, and polyethylene glycol (PEG) 
stool softeners are recommended to prevent constipation. 6. Additional treatments or 
surgery: If other bowel-related examinations (e.g., CT, ultrasound, follow-up 
endoscopy) or surgical interventions are needed, inform the study team in advance; the 
trial may be paused or the subject may withdraw. 
4. Screening failure 
Definition: Screening failure refers to subjects who have signed informed consent 
but do not meet the eligibility criteria or cannot complete baseline assessments, and 
therefore cannot be enrolled. 
Management: 
1. 
The reasons for screening failure must be recorded in detail, including 
failure to meet inclusion/exclusion criteria, incomplete baseline data, or 

 
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withdrawal of consent. 
2. 
The subject should be informed of the screening failure and advised 
on standard medical management as appropriate. 
3. 
Data management: Data from screening failures will not be included 
in the final analysis, but may be used for process optimization and subsequent 
feasibility assessment. 
4. 
Follow-up: Some screening failures may be re-evaluated and may be 
rescreened for eligibility if their condition changes; the process should be 
documented. 
5. Recruitment and retention strategy 
This study will be conducted at Shenzhen Hospital of Southern Medical University. 
We plan to recruit 40 eligible patients scheduled for colorectal ESD via outpatient 
screening, inpatient ward referral, social media announcements, and patient education 
sessions, and randomize them 1:1 to the FASTER-assisted ESD group and the 
conventional ESD group using a random number table. To improve adherence and 
retention, the study team will maintain contact by phone, email, and WeChat, provide 
postoperative follow-up reminders, and offer health counseling related to colorectal 
lesions. For patients with slow recovery, additional health guidance and psychological 
support will be provided. As the study involves ESD, to ensure safety, minors and 
pregnant women will not be enrolled. All participants must sign written informed 
consent and fully understand the study objectives, methods, and potential risks. These 
measures aim to ensure smooth study conduct while safeguarding participants’ rights 
and safety. 
6. Outcome assessments 
(1) Efficacy assessment. Primary endpoint: 1) Total ESD procedure time (min): 
cumulative time from the start of submucosal injection to the end of submucosal 

 
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dissection. Timing will be recorded synchronously by intraoperative video and the 
operative record, and entered into the case report form (CRF) on the day of the 
procedure. Secondary endpoints: 2) Mucosal dissection time (min): time from the end 
of circumferential incision to complete lesion dissection, measured on intraoperative 
video and entered into the CRF after data compilation. 3) Dissection speed (mm²/min): 
lesion area (mm²) divided by dissection time (min). Lesion area measurement: the 
maximal long diameter (a, mm) and the maximal short diameter perpendicular to it (b, 
mm) will be measured intraoperatively or on the specimen. Area will be calculated 
using the ellipse formula: Area = a × b × π/4 (mm²) and entered into the CRF. 4) 
Complete resection rate (R0): number of cases with negative pathological margins/total 
cases ×100%; entered into the database based on the pathology report. 5) En bloc 
resection rate: number of cases confirmed en bloc by intraoperative assessment and 
postoperative pathology review/total cases ×100%. 6) ESD-related complications 
(bleeding, perforation, muscular injury): ① Perforation rate: number of cases with 
endoscopically visible perforation intraoperatively or clinically plus radiologically 
confirmed perforation within 7 days postoperatively/total cases ×100%; determined 
jointly by the research nurse and attending physician; SAE report within 24 h if 
applicable. ② Bleeding rate: number of cases requiring endoscopic hemostasis 
intraoperatively or bloody stool within 24 h postoperatively with Hb decrease >2 
g/dL/total cases ×100%; recorded in the operative record and 24 h AE/SAE log. ③ 
Muscular injury rate: number of cases with exposure or incision into the muscularis 
requiring clipping or suturing/total cases ×100%. 7) Robotic flexibility indices: number 
of attempts required for a first successful grasp and number of accidental drops. 
“Successful grasp” is defined as the grasper holding tissue with appropriate counter-
traction and providing a good submucosal view. 
(2) Safety assessment: Device-related malfunction, anesthesia-related events, and 

 
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other adverse events during and after the procedure will be recorded. Vital signs are 
considered stable when changes from baseline are <20%. 
(3) Adverse event reporting and follow-up: Any adverse events will be recorded and 
managed according to protocol requirements. Serious adverse events must be reported 
within 24 hours. 
 
VI. Study Intervention 
1. Intervention 
This study compares FASTER-assisted ESD (intervention group) with 
conventional ESD (control group) for colorectal lesions to evaluate safety and 
effectiveness. In the intervention group, the end effector of the FASTER robotic arm 
(EndoFaster; Robomed Medical Co., Ltd., Shenzhen, China) will provide continuous 
multidirectional traction of the lesion margin and allow real-time tension adjustment to 
optimize visualization for submucosal dissection. In the control group, submucosal 
dissection will be performed using conventional ESD. Other intraoperative steps will 
follow standardized procedures in both groups, including lesion marking, submucosal 
injection with normal saline plus indigo carmine, circumferential incision, and 
endoscopic hemostasis when necessary. All subjects will continue acid suppression with 
a PPI or P-CAB after surgery. A lukewarm liquid diet will start 6 hours postoperatively; 
if no discomfort within 24 hours, diet will gradually progress to semi-liquid and soft 
foods until discharge. During hospitalization, the following daily follow-up and 
assessments will be performed: 1) Vital signs (blood pressure, heart rate, temperature, 
respiration) and abdominal examination; 2) Laboratory monitoring (hemoglobin, white 
blood cell count, C-reactive protein); 3) Adverse event recording, including 
postoperative bleeding, perforation, muscular injury–related symptoms, and signs of 
infection. All assessments will be entered daily into progress notes and the CRF to 

 
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ensure data integrity and patient adherence. 
2. Preparation/handling/storage/responsibilities 
This study uses the FASTER robotic system and standard single-channel 
endoscopes. Storage, transport, and allocation must be strictly managed. Study medical 
devices should be stored at 5–30°C with relative humidity ≤93%. Temperature and 
humidity should be monitored and recorded during hospital storage to ensure 
appropriate conditions. Device transport will be coordinated by the study team using 
dedicated medical-device courier services, with transport temperature −40 to 55°C and 
humidity ≤93%. Upon arrival at the hospital, devices must be inspected/accepted and 
promptly stored. 
Regarding device allocation, the intervention group will use FASTER-assisted 
endoscopy and the control group will use conventional standard endoscopy. Allocation 
will follow the randomized design with concealed assignment by an independent 
statistician to ensure scientific rigor and fairness. During the procedure, vital signs, 
whether the procedure proceeds smoothly, device compatibility, and any device-related 
adverse events must be recorded in detail and included in study analyses. 
In addition, the study team must ensure safe device use and provide standardized 
training for all medical staff to ensure consistency of clinical procedures. Any device 
malfunction or abnormality identified during use must be recorded immediately and 
reported to the study team to ensure smooth study conduct. 
3. Concomitant therapy 
During the study, permitted concomitant treatments include appropriate nutritional 
support, proton pump inhibitors, local anesthetics or low-dose opioids for pain control, 
antiemetics (e.g., ondansetron), probiotics, and psychological interventions. All 
concomitant medications and treatments must be recorded. 
4. Emergency management 

 
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If unexpected situations require rescue, medical staff may provide targeted 
medications and treatments, including norepinephrine, ephedrine, or dopamine to raise 
blood pressure; desmopressin, thrombin, or intravenous transfusion to control severe 
bleeding; endoscopic titanium clips to close small perforations or surgery to manage 
large perforations; naloxone, endotracheal intubation, and mechanical ventilation for 
respiratory depression or asphyxia; and aspirin, nitroglycerin, and necessary cardiac 
interventional therapy for myocardial infarction. During resuscitation, intravenous 
access should be established, vital signs monitored in real time with a multifunction 
monitor, cardiopulmonary resuscitation (CPR) performed when necessary, and the 
emergency team involved for ICU transfer when required. All rescue processes must be 
documented in detail, including timing, clinical changes, drug doses and patient 
responses, and all monitoring data, procedural interventions, and imaging results should 
be archived to ensure data integrity and traceability. 
 
VII. Discontinuation of Intervention / Subject Withdrawal and Study Termination 
1. Discontinuation of study intervention 
The study may be temporarily suspended under the following circumstances: 
occurrence of serious safety issues such as gastrointestinal perforation, major bleeding, 
or severe infection with an adverse event rate exceeding a pre-specified threshold; 
discovery of major protocol defects that prevent adequate assessment of device safety 
and effectiveness; or requests from regulatory authorities to protect participants’ rights 
or to modify the study design. 
The duration of suspension will depend on the situation and may be a short pause 
(e.g., 1–2 weeks) for adjustments or permanent termination. During suspension, data 
from enrolled participants will continue to be collected (e.g., symptom improvement 
and adverse event rates) to assess the impact on data integrity. 

 
15 
 
To restart the study, key safety or scientific issues must be resolved (e.g., 
optimizing device use, adjusting procedural workflow, or improving follow-up plans), 
and resumption is allowed only after approval by the ethics committee and regulatory 
authorities. 
During intervention suspension, follow-up will continue. Participants will undergo 
symptom assessment and safety monitoring as scheduled; follow-up methods include 
telephone, WeChat, or outpatient visits. If participants experience adverse reactions or 
have medical needs, the study team will provide medical guidance or recommend 
appropriate treatment to ensure safety. 
2. Discontinuation/withdrawal of subjects 
Criteria for study termination (the trial will be terminated if any of the following 
occurs): 
1) A serious safety issue occurs during the trial; 
2) A major error is found in the clinical trial protocol; 
3) The trial applicant requests termination of the trial; 
4) The ethics committee requests termination of the trial; 
5) The device regulatory authority requests termination of the trial. 
For any subject who withdraws from the study for any reason, the reason must be 
recorded, including but not limited to: 
1) Withdrawal of informed consent; 
2) Sponsor terminates the study; 
3) Serious adverse events affecting continued participation; 
4) Major protocol violation/deviation; 
5) Pregnancy; 
6) Poor compliance; 
7) Loss to follow-up; 

 
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8) The investigator and/or sponsor considers that the subject’s medical condition 
may endanger the subject’s safety or that continuing the study may harm the subject’s 
health. 
3. Loss to follow-up 
To minimize loss to follow-up and reduce missing data, the study team will explain 
the importance of follow-up in detail at the outset, provide a clear schedule, and send 
regular reminders via phone, WeChat, email, and other means. Subjects must provide 
at least two alternate contacts to maintain communication if contact is lost. Remote 
follow-up options such as video calls or telephone interviews will be offered, with 
flexible scheduling to reduce loss due to distance or time constraints. For occasionally 
missing data, supplementation may be attempted via medical record review, subject 
interviews, or family inquiries. Statistical analyses will use intention-to-treat (ITT) 
principles and imputation methods as appropriate to mitigate the impact of missing data. 
 
VIII. Detailed Study Procedures 
1. All subjects must sign the informed consent form before screening. Subjects 
who pass screening may enter the study. 
2. Subjects in the intervention and control groups will be treated according to the 
protocol: the intervention group will receive FASTER-assisted ESD and the control 
group will receive conventional ESD. 
3. During the procedure, vital signs, whether the procedure proceeds smoothly 
(clinical feasibility of FASTER), the operator’s experience, and any device-related 
adverse events will be evaluated and recorded and included in analyses. 
4. During hospitalization, efficacy and complications will be evaluated and 
recorded. 
5.1 Screening period: 

 
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All subjects must complete screening examinations before enrollment and be 
screened according to the inclusion/exclusion criteria. 
（1）Sign the informed consent form; 
（2）Record demographic data: date of birth, sex, initials, height, and weight; 
（3）Medical history and physical examination (including vital signs, perianal 
inspection, and digital rectal examination); 
（4）Other laboratory tests, such as complete blood count, coagulation profile, and 
infection panel; 
（5）Preoperative assessment: electrocardiogram; preoperative colonoscopy 
(biopsy/pathology within 6 months; record lesion location, size, morphology, 
and Paris classification); 
5.2 Treatment period: According to randomization, in the intervention group, at 
the start of the procedure the mechanical arm of the FASTER robot will be attached to 
the endoscope tip. ESD will then be performed following standard steps: 1) lesion 
marking; 2) submucosal injection with normal saline and indigo carmine; 3) 
circumferential incision. After submucosal injection and circumferential incision are 
completed, the mechanical arm is deployed and the end effector grasps and lifts the 
mucosal margin to allow clear visualization of the dissection plane, followed by 
submucosal dissection. Finally, the resected tissue will be retrieved using FASTER 
through the endoscope channel or a suction device. 
In the control group, a transparent distal cap will be attached to the endoscope tip 
at the start of the procedure. Conventional ESD will be performed following standard 
steps: 1) lesion marking; 2) submucosal injection with normal saline and indigo carmine; 
3) circumferential incision; 4) submucosal dissection; 5) tissue retrieval using a suction 
device. Vital signs and any procedure-related serious adverse events will be recorded 
for statistical analysis. 

 
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5.3 Follow-up period: All patients will be followed up during hospitalization. The 
following daily follow-up and assessments will be conducted: 1) Vital signs (blood 
pressure, heart rate, temperature, respiration) and abdominal examination; 2) 
Laboratory monitoring (hemoglobin, white blood cell count, C-reactive protein); 3) 
Adverse event recording, including postoperative bleeding, perforation, muscular 
injury–related symptoms, and signs of infection. Patients who develop symptoms such 
as bleeding, fever, or chest pain during follow-up should promptly undergo blood tests 
and, as needed, chest CT or colonoscopy to clarify the cause of complications. 
 
IX. Observation, Recording, and Management of Adverse Events 
1. Definition of adverse events (AE) 
An adverse event (AE) refers to any unfavorable and unintended sign (including 
abnormal laboratory findings), symptom, disease, or injury occurring after the subject 
has signed informed consent and received study-related procedures, whether or not it is 
considered related to the study device. 
2. Definition of serious adverse events (SAE) 
A serious adverse event (SAE) refers to an AE that results in death, is life-
threatening, requires 
inpatient hospitalization or prolongation of existing 
hospitalization, results in persistent or significant disability/incapacity, causes 
congenital anomaly/birth defect, or is otherwise deemed medically important. 
1) Death; 
2) Life-threatening events; 
3) Hospitalization or prolonged hospitalization; 
4) Persistent or significant disability/incapacity; 
5) Congenital anomaly/birth defect; 
6) Other medically important events as judged by the investigator. 

 
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3. Recording, collection, reporting, and management of AEs 
(1) Collection, reporting, and management of AEs 
AEs occurring from the time the subject signs the informed consent form until 
before use of the study device, and those related to protocol-specified procedures, must 
be recorded on the AE form. 
AE records should include: description of the AE and all related symptoms, time 
of onset, severity, duration, relationship to the study device, measures taken, and final 
outcome/prognosis. AEs must be recorded using medical terminology; if symptoms and 
signs can be attributed to a common etiology, the diagnosis should be recorded where 
possible. Except for disease progression indicators, all clinical events and clinically 
significant laboratory adverse reactions may be managed with reference to the Common 
Terminology Criteria for Adverse Events (CTCAE) v5.0. Treatment-emergent adverse 
reactions will be recorded by the investigator. 
(2) Collection and reporting of SAEs 
All SAEs occurring from the time the subject signs the informed consent form 
through hospitalization after completion of the study device procedure, regardless of 
cause or relationship to the device, must be reported using the SAE report form. If an 
SAE occurs, the investigator must immediately take appropriate measures to ensure 
subject safety, and submit a written report to the medical device clinical trial 
management department of the trial institution, which will issue a written notice to the 
sponsor. The management department shall, within 24 hours, submit written reports to 
the 
corresponding 
ethics 
committee 
and 
to 
the 
provincial/autonomous 
region/municipality food and drug administration department and the health authority 
where the trial institution is located. For deaths, the institution and investigator shall 
provide all required information to the ethics committee and the sponsor. For SAEs and 
device defects that may lead to SAEs, the sponsor shall, within 5 working days of 

 
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becoming aware, notify other participating trial institutions and investigators, and the 
management department shall promptly notify the institution’s ethics committee. The 
initial report should include, as far as possible: report source, device name, SAE name, 
time of occurrence, severity, duration, relationship to the device, measures taken, and 
outcome. 
(3) Pregnancy 
Female subjects of childbearing potential must use effective contraception during 
the study and should avoid pregnancy. 
Pregnancy testing (e.g., urine/serum hCG) should be performed for women of 
childbearing potential at screening as appropriate. 
If pregnancy occurs during the study, it must be reported promptly. Follow-up 
should continue to document pregnancy outcome, and the subject should be withdrawn 
from the study as appropriate. 
(4) Criteria for AE severity assessment 
The investigator will grade AE severity according to the five-grade criteria of NCI 
CTCAE v5.0: 
Grade 1 (Mild): asymptomatic or mild symptoms; clinical or diagnostic 
observations only; intervention not indicated. 
Grade 2 (Moderate): minimal, local or noninvasive intervention indicated; limiting 
age-appropriate instrumental ADL. 
Grade 3 (Severe): medically significant but not immediately life-threatening; 
hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care 
ADL. 
Grade 4 (Life-threatening): urgent intervention indicated. 
Grade 5 (Death): death related to AE. 
(5) Other responsibilities of investigators during SAE follow-up 

 
21 
 
Investigators should arrange appropriate examinations and treatments based on the 
subject’s condition, actively follow up the course and outcomes of the event, update 
SAE information in a timely manner, and complete follow-up reports until the event is 
resolved or stabilized. 
 
X. Data Management 
1. Data management 
(1) Investigators must ensure that data are true, complete, and accurate. 
(2) Any corrections to study records must be made by drawing a line through the 
original entry, writing the corrected data in the margin with the reason, and signing and 
dating by the investigator; erasures or overwriting are not permitted. 
(3) Laboratory test items must be complete. 
2. Data recording and document retention 
Data on the CRF should be recorded using subject codes; subjects may be 
identified only by subject code or initials. 
Data will be managed using Excel. The process includes data entry, source data 
verification, quality control query resolution, database lock, and data export. After 
confirming no outstanding queries, all parties will sign the database lock application 
form, and the data manager will lock the database. After database lock, the data manager 
will export the analysis database for statistical analysis. Locked data cannot be edited. 
Issues identified after lock may be corrected in the statistical analysis program after 
confirmation. 
XI. Data Safety Monitoring 
A Data Safety Monitoring mechanism will be implemented. The study team will 
regularly review safety data and adverse events and report to the ethics committee as 
required. 

 
22 
 
 
XII. Statistical Analysis 
1. Sample size determination 
Based on the effect size reported by Yang Xiaoxiao et al. in a crossover study 
comparing FASTER-assisted ESD with conventional ESD in an ex vivo porcine 
stomach model (total procedure time for beginners: 25.6 ± 7.8 min in the FASTER 
group vs 38.9 ± 13.4 min in the conventional group; P < 0.001), we set a two-sided 
significance level α = 0.05 and power 1−β = 0.90 (β = 0.10). PASS 15 software was 
used to estimate sample size based on a two-independent-sample t-test model, yielding 
16 subjects per group. Allowing for a 20% loss-to-follow-up rate, the final sample size 
is 20 subjects per group, for a total of 40 subjects. This approach is consistent with 
commonly used methods in clinical trials; however, given differences between ex vivo 
models and real clinical settings in procedural difficulty and time variability, we plan 
an interim sample size re-estimation after 50% enrollment to adjust for the observed 
effect and variance and ensure adequate statistical power. 
2. Definition and selection of analysis sets 
Full Analysis Set (FAS): includes all randomized subjects who received the 
assigned intervention, analyzed according to the intention-to-treat (ITT) principle. 
Safety Set (SS): includes all subjects who underwent the procedure and have at 
least one post-baseline safety assessment. 
Per-Protocol Set (PPS): includes subjects who completed the study without major 
protocol deviations. 
 
3. Statistical methods 
Statistical analyses include: (1) Description of case distribution and baseline 
characteristics; (2) Comparison of feasibility and safety indicators; (3) Comparison of 

 
23 
 
efficacy indicators and postoperative outcomes/complications. 
4. Statistical software and general requirements 
⚫ All statistical analyses will be performed using SPSS version 27. 
⚫ Continuous variables will be described using mean, standard 
deviation, median, maximum, and minimum. 
⚫ Categorical variables will be described using frequency and 
percentage. 
⚫ For the primary study endpoints (safety, effectiveness, postoperative 
outcomes, and complications), chi-square tests will be used for statistical 
comparisons as appropriate. 
 
XIII. Ethical Principles and Requirements for Clinical Research 
The clinical study will comply with the Declaration of Helsinki and relevant 
regulations in the People’s Republic of China, including requirements on informed 
consent, privacy protection, free participation and compensation, risk control, 
protection of special populations, and compensation for research-related injury. The 
study will be implemented only after approval of this protocol by the Ethics 
Committee. Before enrollment, investigators must fully and comprehensively explain 
to the subject and/or their legal representative the purpose, procedures, and potential 
risks of the study, and obtain written informed consent. Subjects must be informed 
that participation is entirely voluntary, that they may refuse or withdraw at any stage 
without discrimination or retaliation, and that their medical care and rights will not be 
affected. The informed consent form will be retained as a study document for 
inspection. Participants’ privacy and data confidentiality will be strictly protected. 
XIV. Study timeline 
November 2025–March 2026: Complete patient recruitment, randomization, and 

 
24 
 
treatment. 
April 2026–July 2026: Complete follow-up and data statistical analysis. 
August 2026–November 2026: Complete manuscript preparation. 
 
XV. Key References 
[1] 
BRAY F, LAVERSANNE M, SUNG H, et al. Global cancer statistics 2022: 
GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 
185 countries [J]. CA Cancer J Clin, 2024, 74(3): 229-63. 
[2] 
PIMENTEL-NUNES P, LIBâNIO D, BASTIAANSEN B A J, et al. Endoscopic 
submucosal dissection for superficial gastrointestinal lesions: European Society 
of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022 [J]. Endoscopy, 
2022, 54(6): 591-622. 
[3] 
YAMAMOTO K, SHIMODA R, OGATA S, et al. Perforation and Postoperative 
Bleeding Associated with Endoscopic Submucosal Dissection in Colorectal 
Tumors: An Analysis of 398 Lesions Treated in Saga, Japan [J]. Intern Med, 
2018, 57(15): 2115-22. 
[4] 
NAGATA M. Device-assisted traction methods in colorectal endoscopic 
submucosal dissection and options for difficult cases [J]. World J Gastrointest 
Endosc, 2023, 15(4): 265-72. 
[5] 
UYAMA I, KANAYA S, ISHIDA Y, et al. Novel integrated robotic approach for 
suprapancreatic D2 nodal dissection for treating gastric cancer: technique and 
initial experience [J]. World J Surg, 2012, 36(2): 331-7. 
[6] 
YEUNG B P, CHIU P W. Application of robotics in gastrointestinal endoscopy: 
A review [J]. World J Gastroenterol, 2016, 22(5): 1811-25. 
[7] 
PHEE S J, REDDY N, CHIU P W, et al. Robot-assisted endoscopic submucosal 
dissection is effective in treating patients with early-stage gastric neoplasia [J]. 
Clin Gastroenterol Hepatol, 2012, 10(10): 1117-21. 
[8] 
YANG X X, FU S C, JI R, et al. A novel flexible auxiliary single-arm 
transluminal endoscopic robot facilitates endoscopic submucosal dissection of 
gastric lesions (with video) [J]. Surg Endosc, 2022, 36(7): 5510-7. 
[9] 
JI R, YANG J L, YANG X X, et al. Simplified robot-assisted endoscopic 
submucosal dissection for esophageal and gastric lesions: a randomized 
controlled porcine study (with videos) [J]. Gastrointest Endosc, 2022, 96(1): 
140-7. 
[10] 
CUI C, LU X, ZUO X L, JI R. Endoscopic submucosal dissection of early 
gastric angle cancer by using a simplified robot-assisted device for traction [J]. 
Endoscopy, 2024, 56(S 01): E49-e50. 
[11] 
TURIANI HOURNEAUX DE MOURA D, AIHARA H, JIRAPINYO P, et al. 

 
25 
 
Robot-assisted endoscopic submucosal dissection versus conventional ESD for 
colorectal lesions: outcomes of a randomized pilot study in endoscopists 
without prior ESD experience (with video) [J]. Gastrointest Endosc, 2019, 90(2): 
290-8. 

 
26 
 
  
Participant Signature Page 
 
Efficacy of Simplified Robot (FASTER)–Assisted Versus Conventional 
Endoscopic Submucosal Dissection (ESD) for Colorectal Lesions: A Prospective, 
Randomized, Controlled Trial 
 
Informed Consent Statement: 
  I have been informed of the purpose, background, procedures, risks, and 
potential benefits of this study. I have had sufficient time and opportunity to ask 
questions, and I am satisfied with the answers provided.  
I have also been informed whom to contact if I have questions, wish to report 
difficulties or concerns, have suggestions about the study, want further information, 
or wish to offer assistance to the study. I understand that I may choose not to 
participate in this study, or may withdraw from the study at any time during the study 
without giving any reason. In addition, the investigators have not used deception, 
inducement, coercion, or other means to force me to agree to participate in the study.               
I understand that if my condition worsens, or I experience a serious adverse reaction, 
or my study physician believes that continuing participation is not in my best interest, 
he/she may decide to withdraw me from the study. The sponsor or regulatory 
authorities may also terminate the study during the study period without obtaining 
my consent. If this occurs, the physician will notify me in a timely manner and the 
study physician will discuss my other options with me.  
I have read this informed consent form and agree to participate in this study. I 
will receive a copy of this informed consent form bearing the signatures of both 
myself and the investigator. 
Participant signature:                              Date: 

 
27 
 
Contact phone number: 
Legal representative signature:        Relationship:          Date: 
Contact phone number:  
(Note: If the participant lacks or has limited capacity to act, such as inclusion of 
vulnerable groups with mental disorders or impaired consciousness, the legal 
representative must sign in the space below.) 
Independent witness signature:                 Date: 
Contact phone number:  
(Note: An independent witness signature is required only when the participant may have 
decision-making capacity but is unable to read the text (e.g., illiterate, visually 
impaired). When a witness is present, the investigator should, if possible, retain video 
documentation as evidence of informed consent.) 
 I have accurately explained this document to the participant, he/she has read this 
informed consent form accurately, and I confirm that the participant had the opportunity 
to ask questions and voluntarily agreed. 
Investigator signature:                            Date： 
Contact phone number：