Actively Recruiting
Magnetic Anchor Guided Endoscopic Submucosal Dissection for Gastric and Colorectal Superficial Lesions - a Pilot Study
Led by Chinese University of Hong Kong · Updated on 2025-05-08
20
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
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 retractor's 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.
CONDITIONS
Brief Title
Magnetic Guided Counetrtraction During Endoscopic Submucosal Dissection
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient with superficial gastric or colorectal lesions, scheduled for endoscopic submucosal dissection (ESD).
- Age between 18 and 85 years
You will not qualify if you...
- Patient who refused to participate
- Cases deemed unsuitable for safe treatment by the examining physician
- Patient with a cardiac pacemaker
- Patient with any metallic implant or device, such as drug pump or stent
- Patient with metal fragments in the eye or any other part of the body, or history of working with metal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure duration on treatment day
Participants undergo endoscopic submucosal dissection (ESD) assisted by a magnetic retractor system to remove superficial gastric or colorectal lesions. The magnetic device provides dynamic traction controlled externally to facilitate the procedure.
1 treatment visit (in-person)
Duration - 30 days
Participants are monitored for safety and clinical outcomes after the procedure, including assessment of adverse events and lesion resection success.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
H
Hon Chi Yip, MBChB, FRCSEd (General)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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