Colorectal LesionsNCT07354867
Effect of Simplified Robot (FASTER) Assisted Versus Conventional Endoscopic Submucosal Dissection (ESD) for Colorectal Lesions
A study testing FASTER robot-assisted ESD group and Conventional ESD group in people with Colorectal Lesions and Endoscopic Submucosal Dissection (ESD), run by Kaiyun Liu.
Trial summary
This study aims to compare the outcomes of Simplified Robot (FASTER) assisted Endoscopic Submucosal Dissection (ESD) with conventional ESD in the treatment of colorectal lesions. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Lesions, Endoscopic Submucosal Dissection (ESD), FASTER Robot
- What is being tested?
- FASTER robot-assisted ESD group and Conventional ESD group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 6 Jan 2026to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years.
- Patients with colorectal lesions scheduled to undergo endoscopic submucosal dissection (ESD)
- 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;
- Willingness to participate in the study and provision of written informed consent.
Who cannot join
- Suspected deep submucosal invasive carcinoma based on endoscopic features；
- Lesions presenting with non-lifting signs, suggesting deep submucosal invasive carcinoma or tumors with severe submucosal fibrosis;
- Lesions extending to the appendiceal orifice, colonic diverticulum, or ileocecal valve; (4) Pregnant women or women who may be pregnant; lactating women;
- Pregnant women or women who may be pregnant; lactating women;
- Patients with coagulation disorders;
- Patients considered ineligible for specific reasons;
- Patients with contraindications to anesthesia and/or colonoscopy. -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Simplified Robot (FASTER) Assisted Versus Conventional Endoscopic Submucosal Dissection (ESD) for Colorectal Lesions: A Prospective, Randomized, Controlled Trial
This study aims to compare the outcomes of Simplified Robot (FASTER) assisted Endoscopic Submucosal Dissection (ESD) with conventional ESD in the treatment of colorectal lesions. Using a prospective, single-center, randomized controlled design, the investigators will systematically evaluate differences between the two approaches in terms of total procedure time, mucosal dissection time and speed, resection quality (R0 resection rate and en bloc resection rate), incidence of complications (bleeding, perforation, muscularis injury), and the flexibility and clinical feasibility of robotic operation. The clinical significance of this study lies in assessing the value of robotic assistance in colorectal ESD, optimizing intraoperative workflow, reducing complication risks, improving patient outcomes and procedural efficiency, and providing evidence to support individualized therapeutic strategies in clinical practice.This study aims to compare the outcomes of Simplified Robot (FASTER) assisted Endoscopic Submucosal Dissection (ESD) with conventional ESD in the treatment of colorectal lesions. Using a prospective, single-center, randomized controlled design, the investigators will systematically evaluate differences between the two approaches in terms of total procedure time, mucosal dissection time and speed, resection quality (R0 resection rate and en bloc resection rate), incidence of complications (bleeding, perforation, muscularis injury), and the flexibility and clinical feasibility of robotic operation. The clinical significance of this study lies in assessing the value of robotic assistance in colorectal ESD, optimizing intraoperative workflow, reducing complication risks, improving patient outcomes and procedural efficiency, and providing evidence to support individualized therapeutic strategies in clinical practice.
Read the detailed description
This study is a prospective, single-center, randomized controlled trial enrolling patients scheduled to undergo endoscopic submucosal dissection (ESD) for colorectal lesions. Eligible subjects will be screened according to predefined inclusion and exclusion criteria and, after providing written informed consent, randomized 1:1 to the experimental group (FASTER robot-assisted ESD) or the control group (conventional ESD). All participants will undergo standardized ESD performed by experienced endoscopists.
In the experimental group, after a circumferential incision is completed, the FASTER robotic arm will be used; its end-effector grasper will apply multidirectional traction to the lesion margins to optimize the submucosal field before completing the dissection. The control group will undergo mucosal-submucosal dissection using conventional ESD techniques.
Postoperatively, all participants will receive routine acid-suppression therapy and begin a warm, cool liquid diet 6 hours after the procedure. If no intolerance occurs within 24 hours, the diet will be advanced stepwise to semi-liquid and then soft foods until discharge.
During treatment, the following parameters will be recorded and evaluated: total procedure time, mucosal dissection time and dissection speed, resection quality (R0 resection rate and en-bloc resection rate), complication rates (bleeding, perforation, muscularis propria injury), procedural stability, and robotic maneuverability. All participants will be followed during the postoperative hospitalization period, with collection of clinical status, laboratory results, and device-related information.
The study team will conduct statistical analyses to compare the two approaches in terms of efficacy and safety, evaluate their clinical applicability, and provide scientific evidence to support optimization of colorectal ESD workflows and the broader adoption of robot-assisted technology.
- Being tested
- FASTER robot-assisted ESD group, Conventional ESD group
- Keywords
- Endoscopic Submucosal Dissection (ESD), Colorectal lesions, FASTER robot, Procedure time, Randomized controlled trial (RCT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FASTER robot-assisted ESD groupOther
In the experimental group, the FASTER robotic arm will be attached to the tip of the endoscope at the beginning of the procedure. ESD will then be performed according to the standard steps of conventional ESD: (1) lesion marking; (2) submucosal injection with normal saline mixed with indigo carmine; and (3) circumferential incision. After completion of the submucosal injection and circumferential incision, the robotic arm will be deployed, and the end-effector grasper will grasp and lift the mucosal edge to provide a clear view of the dissection plane, after which submucosal dissection will be performed. Finally, the resected specimen will be retrieved using the FASTER system through the endoscope or via suction. Throughout the procedure, patients' vital signs and any procedure-related serious adverse events will be recorded for statistical analysis
Conventional ESD groupOther
In the control group, a transparent distal attachment cap will be mounted onto the tip of the endoscope at the beginning of the procedure. ESD will then be performed following the standard steps of conventional ESD, including: (1) lesion marking; (2) submucosal injection using normal saline mixed with indigo carmine; (3) circumferential incision; (4) submucosal dissection; and (5) retrieval of the resected specimen via suction. Throughout the procedure, patients' vital signs and any procedure-related serious adverse events will be recorded for statistical analysis.
| Study group | Role | What they receive |
|---|---|---|
| FASTER robot-assisted ESD group | Experimental | FASTER robot-assisted ESD group - Patients undergo ESD with the FASTER robotic arm attached to the endoscope tip, with robotic grasping to assist submucosal dissection. Receives: Other: FASTER robot-assisted ESD group |
| Conventional colorectal ESD | Active comparator | Conventional colorectal ESD - Patients undergo standard ESD using a transparent distal cap without robotic assistance. Receives: Other: Conventional ESD group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total procedure time
Measured from initiation of submucosal injection to completion of submucosal dissection.
Measured: Recorded intraoperatively
Secondary outcomes (7)
En bloc resection rate
Defined as whether the lesion was resected in a single piece, assessed immediately after resection by the endoscopist.
Measured: Periprocedural (intraoperative assessment)
Submucosal dissection time
Measured from completion of circumferential incision to complete removal of the lesion
Measured: Recorded intraoperatively
Robotic operational flexibility
Number of attempts required for successful grasp and number of accidental drops. Successful grasp defined as effective traction providing clear submucosal visualization.
Measured: Recorded intraoperatively
Dissection speed
Calculated as lesion area divided by dissection time. Lesion area is determined intraoperatively or from the resected specimen using the longest diameter (a) and the perpendicular diameter (b), applying the ellipse formula: area = a × b × π/4.
Measured: Periprocedural (from intraoperative measurement to postoperative calculation within 24 hours)
Incidence of device malfunction
Device malfunctions (arm jamming, vision interruption, waterway obstruction/leakage) will be recorded intraoperatively and expressed as events per total cases.
Measured: Recorded intraoperatively
Rates of intraoperative and postoperative complications
Intraoperative and postoperative complications such as bleeding, perforation, and muscularis propria injury will be documented. Based on established clinical diagnostic criteria and the corresponding medical records, these events will be assessed by the study investigators and recorded in the CRF.
Measured: Periprocedural (from intraoperative period through hospital discharge, up to 7 days)
Complete resection rate
Defined as en bloc resection with histologically tumor-free lateral and vertical margins (R0 resection).
Measured: Within 7 days post-procedure (upon pathology report issuance)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2026
- Study start6 Jan 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal LesionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: a FASTER robot-assisted ESD group or a conventional ESD group. Both groups will undergo the assigned endoscopic submucosal dissection procedure for colorectal lesions performed by experienced endoscopists. In the robot-assisted group, the FASTER robotic arm will provide multidirectional traction using its end-effector grasper to optimize the submucosal field during dissection, whereas the control group will complete submucosal dissection using standard ESD techniques. Outcomes will be compared between groups to evaluate differences in procedure time, mucosal dissection time and speed, resection quality, complication rates, procedural stability, and robotic maneuverability.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiyun Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kaiyun Liu, Shenzhen Hospital of Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07354867
- Sponsor's protocol ID
- NYSZYYEC2025K111R002
- Status last verified
- Oct 2025
- First submitted
- 4 Jan 2026
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Simplified Robot (FASTER) Assisted Versus Conventional Endoscopic Submucosal Dissection (ESD) for Colorectal Lesions: A Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT07354867
- Acronym / sponsor ID
- NYSZYYEC2025K111R002
- Keywords
- Endoscopic Submucosal Dissection (ESD), Colorectal lesions, FASTER robot, Procedure time, Randomized controlled trial (RCT)
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kaiyun LiuUniversity, hospital or other
- Study start
- 6 Jan 2026 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 21 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the outcomes of Simplified Robot (FASTER) assisted Endoscopic Submucosal Dissection (ESD) with conventional ESD in the treatment of colorectal lesions. Using a prospective, single-center, randomized controlled design, the investigators will systematically evaluate differences between the two approaches in terms of total procedure time, mucosal dissection time and speed, resection quality (R0 resection rate and en bloc resection rate), incidence of complications (bleeding, perforation, muscularis injury), and the flexibility and clinical feasibility of robotic operation. The clinical significance of this study lies in assessing the value of robotic assistance in colorectal ESD, optimizing intraoperative workflow, reducing complication risks, improving patient outcomes and procedural efficiency, and providing evidence to support individualized therapeutic strategies in clinical practice.This study aims to compare the outcomes of Simplified Robot (FASTER) assisted Endoscopic Submucosal Dissection (ESD) with conventional ESD in the treatment of colorectal lesions. Using a prospective, single-center, randomized controlled design, the investigators will systematically evaluate differences between the two approaches in terms of total procedure time, mucosal dissection time and speed, resection quality (R0 resection rate and en bloc resection rate), incidence of complications (bleeding, perforation, muscularis injury), and the flexibility and clinical feasibility of robotic operation. The clinical significance of this study lies in assessing the value of robotic assistance in colorectal ESD, optimizing intraoperative workflow, reducing complication risks, improving patient outcomes and procedural efficiency, and providing evidence to support individualized therapeutic strategies in clinical practice.
Detailed description
This study is a prospective, single-center, randomized controlled trial enrolling patients scheduled to undergo endoscopic submucosal dissection (ESD) for colorectal lesions. Eligible subjects will be screened according to predefined inclusion and exclusion criteria and, after providing written informed consent, randomized 1:1 to the experimental group (FASTER robot-assisted ESD) or the control group (conventional ESD). All participants will undergo standardized ESD performed by experienced endoscopists.
In the experimental group, after a circumferential incision is completed, the FASTER robotic arm will be used; its end-effector grasper will apply multidirectional traction to the lesion margins to optimize the submucosal field before completing the dissection. The control group will undergo mucosal-submucosal dissection using conventional ESD techniques.
Postoperatively, all participants will receive routine acid-suppression therapy and begin a warm, cool liquid diet 6 hours after the procedure. If no intolerance occurs within 24 hours, the diet will be advanced stepwise to semi-liquid and then soft foods until discharge.
During treatment, the following parameters will be recorded and evaluated: total procedure time, mucosal dissection time and dissection speed, resection quality (R0 resection rate and en-bloc resection rate), complication rates (bleeding, perforation, muscularis propria injury), procedural stability, and robotic maneuverability. All participants will be followed during the postoperative hospitalization period, with collection of clinical status, laboratory results, and device-related information.
The study team will conduct statistical analyses to compare the two approaches in terms of efficacy and safety, evaluate their clinical applicability, and provide scientific evidence to support optimization of colorectal ESD workflows and the broader adoption of robot-assisted technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to one of two parallel groups: a FASTER robot-assisted ESD group or a conventional ESD group. Both groups will undergo the assigned endoscopic submucosal dissection procedure for colorectal lesions performed by experienced endoscopists. In the robot-assisted group, the FASTER robotic arm will provide multidirectional traction using its end-effector grasper to optimize the submucosal field during dissection, whereas the control group will complete submucosal dissection using standard ESD techniques. Outcomes will be compared between groups to evaluate differences in procedure time, mucosal dissection time and speed, resection quality, complication rates, procedural stability, and robotic maneuverability.
| Arm | Type | Receives |
|---|---|---|
| FASTER robot-assisted ESD group | Experimental | Other: FASTER robot-assisted ESD groupFASTER robot-assisted ESD group - Patients undergo ESD with the FASTER robotic arm attached to the endoscope tip, with robotic grasping to assist submucosal dissection. |
| Conventional colorectal ESD | Active comparator | Other: Conventional ESD groupConventional colorectal ESD - Patients undergo standard ESD using a transparent distal cap without robotic assistance. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 80 years.
- Patients with colorectal lesions scheduled to undergo endoscopic submucosal dissection (ESD)
- 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;
- Willingness to participate in the study and provision of written informed consent.
Key exclusion criteria (7 listed)
- Suspected deep submucosal invasive carcinoma based on endoscopic features；
- Lesions presenting with non-lifting signs, suggesting deep submucosal invasive carcinoma or tumors with severe submucosal fibrosis;
- Lesions extending to the appendiceal orifice, colonic diverticulum, or ileocecal valve; (4) Pregnant women or women who may be pregnant; lactating women;
- Pregnant women or women who may be pregnant; lactating women;
- Patients with coagulation disorders;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FASTER robot-assisted ESD groupIn the experimental group, the FASTER robotic arm will be attached to the tip of the endoscope at the beginning of the procedure. ESD will then be performed according to the standard steps of conventional ESD: (1) lesion marking; (2) submucosal injection with normal saline mixed with indigo carmine; and (3) circumferential incision. After completion of the submucosal injection and circumferential incision, the robotic arm will be deployed, and the end-effector grasper will grasp and lift the mucosal edge to provide a clear view of the dissection plane, after which submucosal dissection will be performed. Finally, the resected specimen will be retrieved using the FASTER system through the endoscope or via suction. Throughout the procedure, patients' vital signs and any procedure-related serious adverse events will be recorded for statistical analysis | Other | FASTER robot-assisted ESD group |
| Conventional ESD groupIn the control group, a transparent distal attachment cap will be mounted onto the tip of the endoscope at the beginning of the procedure. ESD will then be performed following the standard steps of conventional ESD, including: (1) lesion marking; (2) submucosal injection using normal saline mixed with indigo carmine; (3) circumferential incision; (4) submucosal dissection; and (5) retrieval of the resected specimen via suction. Throughout the procedure, patients' vital signs and any procedure-related serious adverse events will be recorded for statistical analysis. | Other | Conventional colorectal ESD |
Primary outcome
Total procedure time
Time frame: Recorded intraoperatively
Measured from initiation of submucosal injection to completion of submucosal dissection.
7 secondary outcomes
En bloc resection rate
Time frame: Periprocedural (intraoperative assessment)
Submucosal dissection time
Time frame: Recorded intraoperatively
Robotic operational flexibility
Time frame: Recorded intraoperatively
Dissection speed
Time frame: Periprocedural (from intraoperative measurement to postoperative calculation within 24 hours)
Incidence of device malfunction
Time frame: Recorded intraoperatively
Rates of intraoperative and postoperative complications
Time frame: Periprocedural (from intraoperative period through hospital discharge, up to 7 days)
Complete resection rate
Time frame: Within 7 days post-procedure (upon pathology report issuance)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing FASTER robot-assisted ESD group and Conventional ESD group in people with Colorectal Lesions and Endoscopic Submucosal Dissection (ESD), run by Kaiyun Liu.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiaobing cui (13631312723, xbing119@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total procedure time (time frame: Recorded intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.