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The Application of a Novel Endoluminal Robotic System for Colorectal Endoscopic Submucosal Dissection
NCT07486180 · Chinese University of Hong Kong · Updated 20 March 2026
- What is being tested
- Colorectal Endoscopic Submucosal Dissection (ESD) Using the Intilume Surgical System
- For
- Early Rectal Neoplasms
- Kind of study
- Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
- Who can join
- Ages 18 years and older. About 10 people. The full rules are on the registry page.
- Where
- China
- When
- Starts or started April 2026, ends April 2027. Registered 20 March 2026.
- Results
- None posted yet.
In the researchers' words
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…
Sites
- Prince of Wales Hospital, The Chinese University of Hong KongHong Kong, China
