Assessment of the EndoR System in ESD for Colorectal Lesions

NCT07405203 | Active Not Recruiting

• 1 other identifier: CRE-2025.546
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

Gastrointestinal (GI) cancers are common and significant causes of cancer death worldwide. GI cancers grow from the mucosal layer. If pre-malignant and early cancers are removed en bloc at an early stage before they spread to lymph nodes, survival rates can be improved. Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) were developed as minimally invasive, organ-sparing methods for removing pre-malignant and early GI cancers. While EMR is suitable for smaller lesions, ESD is typically required for larger lesions. ESD offers the advantage of a higher rate of complete, single-piece resection, which is associated with a lower risk of local recurrence compared to EMR. However, ESD is a technically complex procedure with a higher risk of complications, such as perforation and bleeding. Conventional ESD is performed using a flexible endoscope with a single instrument channel to access the GI tract. This setup presents several challenges, including difficulty in maintaining the endoscope in a stable position, limited ability to provide effective tissue traction, and frequent intraprocedural bleeding. As a result, ESD demands a high level of technical skills from surgeons. The EndoR Surgical System was developed to address these challenges, aiming to allow surgeons to operate two surgical instruments with enhanced dexterity and a broader range of motions. Both pre-clinical ex-vivo studies and in-vivo studies were conducted in the development of this surgical system. Six pre-clinical ex-vivo studies were conducted in porcine stomach between 2015 and 2023 and eleven pre-clinical in-vivo studies were conducted in live porcine models with the lesion sites at stomach, rectum and left colon between 2016 and 2024. These pre-clinical studies were conducted in LASEC-PWH, MISSC-PWH and Hybrid Operating Room of Multi-Scale Medical Robotics Center (MRC) accordingly. Based on data from the ex-vivo and in-vivo experiments, two key conclusions can be drawn: i) After several training sessions, the operator's performance became more consistent and efficient. ii) The dissection rate increased as the dissection area grew-a phenomenon not observed in conventional procedures using a single endoscope and dissection tool. From the results demonstrated from the pre-clinical studies, the EndoR Surgical System allows for greater dexterity and precision in manipulating instruments, which is particularly advantageous for larger lesions. This precision can lead to more effective dissection and reduced damage to surrounding tissues. This may also reduce the risk of complications associated with ESD. By minimizing trauma to adjacent structures, the likelihood of adverse events, such as bleeding or perforation, may be significantly lowered. Patients may experience faster recovery times, contributing to improved patients' satisfaction and outcomes. As the risk of complications decreases, endoscopic procedures like ESD could become accessible to a broader patient population. While performing ESD is generally considered safe, it still remains a technically demanding procedure with the assistance of the surgical robotic system. The use of surgical robots introduces the risk of equipment malfunctions, which can lead to complications during the procedure. Additionally, any technical issues may result in delays, potentially compromising patient safety. The attending physicians will monitor and examine the subjects as necessary and appropriate and work carefully to ensure their safety. In the event of an adverse reaction, countermeasures will be taken as appropriate, and focus will be placed on ensuring the safety of the subjects while the cause of the reaction is investigated. The objective of this study is to assess the safety and performance of the EndoR Surgical System for the treatment of patients with colorectal malignant lesions. Technical success, clinical success and any adverse events shall be recorded.

Conditions

Colorectal Lesions

Keywords

EndoR; ESD; Endoscopic Submucosal Dissection

Outcome Measures

Primary Outcomes (1)

• Rate of complete (R0) resection

  Defined as en bloc, one-piece resection with histologically confirmed tumor-free lateral and vertical margins. Unit of measure: % of procedures

  1 day

Secondary Outcomes (32)

• [Safety] Rate of intraoperative bleeding

  1 day

• [Safety] Rate of adjunctive procedures

  1 day

• [Safety] All-cause mortality

  12 months

• [Safety] Rate of infection

  30 days

• [Safety] Rate of Serious Adverse Events (SAEs)

  12 months

Other Outcomes (5)

• Rate of Major Adverse Events (MAE)

  30 days

• Rate of intra-procedural bleeding (MAE)

  1 day

• Rate of post-procedure perforation (MAE)

  30 days

Study Arms (1)

EndoR System assisted ESD

EXPERIMENTAL

Recruited subjects will undergo robotic ESD under general anesthesia using EndoR Surgical System.

Device: EndoR Surgical System

Interventions

EndoR Surgical System DEVICE

The EndoR Surgical System is a master-slave robotic platform designed for endoscopic surgery, featuring flexible dual arms and cognitive control system.

EndoR System assisted ESD

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged between 18 and 85.
• Patient with superficial colorectal lesions, scheduled for endoscopic submucosal dissection (ESD). According to the European Society of Gastrointestinal Endoscopy (ESGE) and the Japan Gastroenterological
• Endoscopy Society (JGES) guidelines for colorectal ESD:
• i. Lesions for which en bloc resection with snare EMR would be difficult to apply; ii. Mucosal tumors with submucosal fibrosis; iii. Sporadic tumors in conditions of chronic inflammation; iv. Local residual or recurrent early carcinomas after endoscopic resection.

You may not qualify if:

• No informed consent available.
• Carcinoma of colon or rectum with invasion to submucosa or beyond.
• Evidence of distant metastasis.
• Another active malignancy present.
• Pregnant.
• Patients are unfit for general anesthesia.
• The target lesion that could not be reached by the endoscopic platform.
• Have been recruited in another clinical trial.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Related Publications (5)

• Akahoshi K, Akahane H, Murata A, Akiba H, Oya M. Endoscopic submucosal dissection using a novel grasping type scissors forceps. Endoscopy. 2007 Dec;39(12):1103-5. doi: 10.1055/s-2007-966842.

  PMID: 18072064 BACKGROUND

• Teoh AY, Chiu PW, Wong SK, Sung JJ, Lau JY, Ng EK. Difficulties and outcomes in starting endoscopic submucosal dissection. Surg Endosc. 2010 May;24(5):1049-54. doi: 10.1007/s00464-009-0724-8. Epub 2009 Nov 13.

  PMID: 19911227 BACKGROUND

• Oka S, Tanaka S, Kaneko I, Mouri R, Hirata M, Kawamura T, Yoshihara M, Chayama K. Advantage of endoscopic submucosal dissection compared with EMR for early gastric cancer. Gastrointest Endosc. 2006 Dec;64(6):877-83. doi: 10.1016/j.gie.2006.03.932. Epub 2006 Sep 20.

  PMID: 17140890 BACKGROUND

• ASGE TECHNOLOGY COMMITTEE; Kantsevoy SV, Adler DG, Conway JD, Diehl DL, Farraye FA, Kwon R, Mamula P, Rodriguez S, Shah RJ, Wong Kee Song LM, Tierney WM. Endoscopic mucosal resection and endoscopic submucosal dissection. Gastrointest Endosc. 2008 Jul;68(1):11-8. doi: 10.1016/j.gie.2008.01.037. No abstract available.

  PMID: 18577472 BACKGROUND

• Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.

  PMID: 25220842 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 12, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)