Robotic Magnetic Guidance to Assist Endoscopic Submucosal Dissection for Early Gastric and Colon Lesions A Pilot Study Evaluating Safety and Effectiveness

What this Trial Is About

Researchers are evaluating a novel robotic magnetic countertraction system called MAG-ESD to assist with endoscopic submucosal dissection ESD for treating early gastric and colorectal superficial lesions. ESD is a procedure used to remove early gastrointestinal tumors while preserving the organ, but it is technically challenging, especially for flat or large lesions. This study aims to test the safety and effectiveness of MAG-ESD, which offers dynamic and adjustable traction during ESD to improve visibility and reduce procedure time. The MAG-ESD system includes two parts an external permanent magnet held by a robotic arm and a disposable magnetic retractor clipped inside the patient. The external magnet can be moved to control the internal retractors position during the procedure without needing to withdraw the endoscope. This device provides consistent and dynamic traction, potentially making the ESD process easier and faster. The study will involve 20 patients undergoing gastric or colonic ESD using this magnetic guidance system. Participants will undergo assessments to measure the technical success rate of the procedure within one day and clinical success within 30 days. Researchers will also track procedure times, lesion size and location, task load on surgeons, and any adverse events during and after the procedure. Safety monitoring includes checking for muscle injury, perforations, bleeding, and post-procedural complications. The total participation duration covers procedure and follow-up assessments up to 30 days to evaluate outcomes and safety.

Magnetic Guided Counetrtraction During Endoscopic Submucosal Dissection