Effect of Simplified Robot (FASTER) Assisted Versus Conventional Endoscopic Submucosal Dissection (ESD) for Colorectal Lesions

NCT07354867 | Not Yet Recruiting DMC

• 1 other identifier: NYSZYYEC2025K111R002
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Colorectal Lesions; Endoscopic Submucosal Dissection (ESD); FASTER Robot

Keywords

Endoscopic Submucosal Dissection (ESD); Colorectal lesions; FASTER robot; Procedure time; Randomized controlled trial (RCT)

Outcome Measures

Primary Outcomes (1)

• Total procedure time

  Measured from initiation of submucosal injection to completion of submucosal dissection.

  Recorded intraoperatively

Secondary Outcomes (7)

• En bloc resection rate

  Periprocedural (intraoperative assessment)

• Submucosal dissection time

  Recorded intraoperatively

• Robotic operational flexibility

  Recorded intraoperatively

• Dissection speed

  Periprocedural (from intraoperative measurement to postoperative calculation within 24 hours)

• Incidence of device malfunction

  Recorded intraoperatively

Study Arms (2)

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.

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.

Other: Conventional ESD group

Interventions

FASTER robot-assisted ESD group OTHER

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

FASTER robot-assisted ESD group

Conventional ESD group OTHER

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.

Conventional colorectal ESD

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Kaiyun Liu: lead

Central Study Contacts

xiaobing cui

CONTACT

13631312723; xbing119@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is a single-blind study in which the outcomes assessor is blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 21, 2026
• Study Start: January 6, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: January 21, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share