The Application of a Novel Endoluminal Robotic System for Colorectal Endoscopic Submucosal Dissection

Performance, Feasibility, and Safety Study For A Novel Endoluminal Robotic System for Colorectal Endoscopic Submucosal Dissection (ESD): First-in-Human Trial

Endoluminal surgery through natural orifices is an effective, "incisionless" treatment for benign lesions and early-stage cancers in the urinary tract and gastrointestinal (GI) tract. However, current practice suffers from the use of basic surgical instruments that lack dexterity and the ability to perform effective tissue retraction and provide triangulation. This is illustrated in endoscopic submucosal dissection (ESD) of GI tumors, which is a highly effective technique that has limited widespread adoption due to the exceptionally steep learning curve created by unintuitive and cumbersome instruments. It is suggested that a robotic system may improve en bloc resection capabilities in the GI tract by providing surgeons with dexterous and precise bimanual instrument control. This study aims to evaluate the clinical feasibility and safety of colorectal ESD using a novel endoluminal robotic system - the Intilume System by Agilis Robotics. It is a prospective, single center study consistent with a Stage 1 (Innovation) study described in the Innovation, Development, Exploration, Assessment, Long-term Study (IDEAL) framework. The primary study endpoints are en bloc resection rate and perioperative complications. The secondary study endpoints include R0 resection rate, dissection related metrics, conversion rate, and post-procedure recovery. This study will provide information on the feasibility and safety of the Intilume System developed by Agilis Robotics in performing colorectal ESD. This study may provide pertinent evidence for the continued development of this robotic technology.

Study Overview

• Status: Not yet recruiting
• Conditions: Early Rectal Neoplasms
• Intervention / Treatment: Procedure: Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Simon SM Ng, MD; Phone Number: +852-35051495; Email: simonng@surgery.cuhk.edu.hk
• Study Contact Backup: Name: Kaori Futaba, MD; Phone Number: +852-35051495; Email: kfutaba@surgery.cuhk.edu.hk

Study Locations

• China
  • Hong Kong, China
    • Prince of Wales Hospital, The Chinese University of Hong Kong
    • Contact: Simon SM Ng, MD; Phone Number: +852-35051495; Email: simonng@surgery.cuhk.edu.hk
    • Contact: Kaori Futaba, MD; Phone Number: +852-35051495; Email: kfutaba@surgery.cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients diagnosed with nonpedunculated early rectal neoplasms >/= 2 cm in size in the rectum (>/= 3 cm and </= 18 cm from the anal verge) that are deemed not feasible for en bloc resection with conventional polypectomy or endoscopic mucosal resection (EMR) as judged by two experienced endoscopists
• American Society of Anesthesiologists (ASA) grading I-III
• Informed consent available

Exclusion Criteria:

• Presence of endoscopic signs of massive submucosal invasion (including excavated/depressed morphology, Kudo's pit pattern Type V, or Sano's capillary pattern Type IIIB)
• Evidence of deep invasion on endorectal ultrasonography
• Unfavorable histopathologic features on biopsy (mucinous cancer, poor differentiation, or gross submucosal invasion)
• Patients with other synchronous colorectal neoplasms in addition to the index neoplasm that are indicated for surgical resection
• Patients with recurrence from previous EMR or ESD
• Patients with non-correctable coagulopathy
• Patients with contraindications to general anesthesia
• Vulnerable population (e.g., mentally disabled, pregnancy.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System; Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System by Agilis Robotics	Procedure: Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System; Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System by Agilis Robotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
En bloc resection rate	The definition of en bloc resection is resection with a single piece.	Perioperative
Perioperative complications	Perioperative complications including intraoperative complications and all complications occurring during the hospital stay or within 30 days after discharge will be graded according to the Clavien-Dindo classification.	Up to 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to walk independently		Up to 1 month
Length of hospital stay		Up to 1 month
Time to resume normal diet		Up to 1 month
R0 resection rate	R0 resection is defined as complete resection of the neoplasm with clear lateral and deep margins at histology	Perioperative
Endoscopic Submucosal Dissection (ESD) procedure time	Endoscopic Submucosal Dissection (ESD) procedure time is defined as the total duration (in minutes) from the initial submucosal injection (or first marking) to the final removal of the lesion. It typically includes two phases: the circumferential mucosal incision (CIS) and the subsequent submucosal dissection (SDS) phase.	Perioperative
Endoscopic Submucosal Dissection (ESD) dissection speed	Endoscopic Submucosal Dissection (ESD) dissection speed is defined as the surface area of the resected specimen (in cm² or mm²) divided by the time taken (in minutes or hours).	Perioperative
Conversion rate	Conversion rate is defined as an emergent change in the treatment plan to conventional endoscopic submucosal dissection (ESD) or transanal minimally invasive surgery (TAMIS)	Perioperative

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Simon SM Ng, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 17, 2026
• First Submitted That Met QC Criteria: March 17, 2026
• First Posted (Actual): March 20, 2026

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: ESD; Rectal adenomas; Early rectal neoplasms; T1 rectal cancer; Endoluminal robotic system
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms; s-formylglutathione hydrolase
• Other Study ID Numbers: CREC 2026.119

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