Magnetic Guided Counetrtraction During Endoscopic Submucosal Dissection

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorChinese University of Hong Kong

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Patient with superficial gastric or colorectal lesions, scheduled for endoscopic submucosal dissection (ESD).

Disqualifiers

Patient who refused to participate

Other cases deemed by the examining physician as unsuitable for safe treatment

Patient who had a cardiac pacemaker.

Patient who had any metallic implant or device, such as drug pump, stent, etc.

Trial design

Design model

Single group

Treatments tested in this trial

  • MAG-ESD assisted ESD

    Device

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: MAG-ESD assisted ESDExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Technical success rate

Successful en-bloc, without major intra-operative adverse event.

Time frame
1 day

Secondary outcomes

1

Clinical success rate

pathological R0 resection, without major intra-operative and post-operative adverse event.

Time frame
30 days
2

Total procedure time

Time taken from injection to completion of resection

Time frame
1 day
3

MAG-ESD time

Time taken to apply the magnetic traction from introduction of magnetic retractor to the actual countertraction in effect

Time frame
1 day
4

Lesion size

Lesion size

Time frame
1day

Other outcomes

Sponsors and contacts

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