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

January 12, 2026 updated by: Kaiyun Liu

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

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;
  4. Pregnant women or women who may be pregnant; lactating women;
  5. Patients with coagulation disorders;
  6. Patients considered ineligible for specific reasons;
  7. Patients with contraindications to anesthesia and/or colonoscopy. -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FASTER robot-assisted ESD group
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
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
Active Comparator: Conventional colorectal ESD
Conventional colorectal ESD - Patients undergo standard ESD using a transparent distal cap without robotic assistance.
Other: Conventional ESD group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total procedure time
Time Frame: Recorded intraoperatively
Measured from initiation of submucosal injection to completion of submucosal dissection.
Recorded intraoperatively

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
En bloc resection rate
Time Frame: Periprocedural (intraoperative assessment)
Defined as whether the lesion was resected in a single piece, assessed immediately after resection by the endoscopist.
Periprocedural (intraoperative assessment)
Submucosal dissection time
Time Frame: Recorded intraoperatively
Measured from completion of circumferential incision to complete removal of the lesion
Recorded intraoperatively
Robotic operational flexibility
Time Frame: Recorded intraoperatively
Number of attempts required for successful grasp and number of accidental drops. Successful grasp defined as effective traction providing clear submucosal visualization.
Recorded intraoperatively
Dissection speed
Time Frame: Periprocedural (from intraoperative measurement to postoperative calculation within 24 hours)
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.
Periprocedural (from intraoperative measurement to postoperative calculation within 24 hours)
Incidence of device malfunction
Time Frame: Recorded intraoperatively
Device malfunctions (arm jamming, vision interruption, waterway obstruction/leakage) will be recorded intraoperatively and expressed as events per total cases.
Recorded intraoperatively
Rates of intraoperative and postoperative complications
Time Frame: Periprocedural (from intraoperative period through hospital discharge, up to 7 days)
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.
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)
Defined as en bloc resection with histologically tumor-free lateral and vertical margins (R0 resection).
Within 7 days post-procedure (upon pathology report issuance)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kaiyun Liu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 6, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NYSZYYEC2025K111R002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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