NCT07405203

Assessment of the EndoR System in ESD for Colorectal Lesions

Active, enrolled NA Last updated 12 February 2026

What this trial tests

NA trial testing EndoR Surgical System in Colorectal Lesions in 6 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 January 2026

Primary endpoint
31 December 2027

30 June 2028

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	1 January 2026
Primary completion	31 December 2027
Estimated completion	30 June 2028
Sites	1 location across Hong Kong

Drugs / interventions tested

• EndoR Surgical System

Conditions studied

• Colorectal Lesions — all drugs for Colorectal Lesions →

Sponsor

Chinese University of Hong Kong

Who can join

Adults 18 to 85, any sex, with Colorectal Lesions. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.