RecruitingNot ApplicableNCT06962293

Magnetic Guided Counetrtraction During Endoscopic Submucosal Dissection

Magnetic Anchor Guided - Endoscopic Submucosal Dissection (MAG-ESD) for Gastric and Colorectal Superficial Lesions - a Pilot Study


Sponsor

Chinese University of Hong Kong

Enrollment

20 participants

Start Date

May 9, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Endoscopic submucosal dissection (ESD) is a technique that allows curative treatment of early gastrointestinal neoplasia with organ preservation. However, it is a technically demanding procedure. Tissue traction plays a vital role in facilitating the visualization of the cutting line and the submucosal vessels, which usually only relies on the hood attached to the tip of the endoscope. However, when dealing with flat or large lesions, the absence of reliable traction in ESD contributes to its technical complexity and prolongs procedure duration. Various traction devices and techniques have been developed to provide tension for the dissection plane and optimal visibility during ESD. Most of these only provide static traction from a fixed angle, thus the effect of traction diminishes when the dissection continues. In contrast to the aforementioned traction methods, magnetic traction offers the ability to externally manipulate an internal magnetic retractor, simplifying the internal workspace. The proposed magnetic retractor is composed of a detachable clip from an hemoclip is affixed to a magnetic element. By adjusting the position of the external magnetic source, the magnetic retractor automatically couples and aligns with it, enabling simultaneous dynamic directional control during the ongoing ESD operation. A novel robotic magnetic countertraction system was developed (MAG-ESD). The system consists of two sections: an external permanent magnetic source and the disposable magnetic retractor. The external permanent magnetic source is composed by a large external permanent magnet (EPM) which held by robot arm to externally control the locomotion of the magnetic retractor within patient. The disposable magnetic retractor is a consumable surgical instrument that modified from a commercial hemoclip, which has small magnets hangs on the clip legs. The design of the disposable magnetic retractor eliminates the need for endoscope withdrawal which can be inserted through the instrument channel from the handle during ESD operations, like other common instruments. In the current pilot study, the novel MAG-ESD counetrtraction system would be tested in 20 patients who undergo gastric and colonic ESD, with the aim of evaluating the system efficacy and safety.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a magnetically guided device to help doctors perform a procedure called endoscopic submucosal dissection (ESD) — a technique used to remove early-stage growths from the stomach or colon lining. The magnetic system helps control the tissue during the procedure, potentially making it more precise and safer. **You may be eligible if...** - You have a superficial (surface-level) stomach or colon growth that your doctor has scheduled for removal via ESD **You may NOT be eligible if...** - You refuse to participate - You have a cardiac pacemaker - You have any metallic implant or device inside your body (such as a drug pump, stent, or other device) - You have or ever had metal fragments in your eye or body, or have worked in an environment with metal exposure - Your doctor determines it would be unsafe for you to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEMAG-ESD assisted ESD

Flexible magnetic traction device would be used to assist the ESD procedure. Real time adjustment of traction could be achieved by controlling the EPM position and orientation anytime during the procedure.


Locations(1)

Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong

Hong Kong, Hong Kong

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NCT06962293


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