AzTrials
AzTrials

Early Gastric CancerNCT06962293

Magnetic Guided Counetrtraction During Endoscopic Submucosal Dissection

A study testing MAG-ESD assisted ESD in people with Early Gastric Cancer and Colon Neoplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Early Gastric Cancer, Colon Neoplasia
What is being tested?
MAG-ESD assisted ESD
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteHong Kong
Study dates
9 May 2025to 30 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Patient who refused to participate
  • Other cases deemed by the examining physician as unsuitable for safe treatment
  • The robotic magnetic countertraction system consist of a strong permanent magnet which always have a strong magnetic field in its surrounding. Therefore, we follow the MRI precautions for the strict safety measurement:
  • Patient who had a cardiac pacemaker.
  • Patient who had any metallic implant or device, such as drug pump, stent, etc.
  • Patient who has or had any metal fragments in eye or any other part of body, or had ever worked with metal.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hon Chi Yip, MBChB, FRCSEd (General) contact

+85235052956

hcyip@surgery.cuhk.edu.hk

Hong Kong1 site, 1 recruiting
  • Department of Surgery, Faculty of Medicine, the Chinese University of Hong Kong

    Hong Kong

    Hon Chi Yip, MBChB, FRCSEd (General), +85235052956, hcyip@surgery.cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

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

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.

Read the detailed description

Gastrointestinal (GI) cancers accounted for 39.5 million new cases worldwide in 2020, representing 14.7% of the total new cases of cancer. These cancers also led to 18.8 million deaths, constituting 19% of the total deaths caused by cancer. Typically, endoscopic resection is recommended for early-stage tumors within the GI tract, with endoscopic submucosal dissection (ESD) often utilized for submucosal resection. Tissue traction plays a vital role in facilitating the visualization of the cutting line and the submucosal vessels. 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. Examples include the "S-O clip" , "Ring thread", "Multiloop", "Double clip and rubber band" , etc. These methods typically involve the deployment of two or more clips to secure both the lesion site and the organ wall. The clips are constrained by springs or strings, allowing for control of the traction direction by deploying new clips to anchor the device at different locations. There is often a need to introduce a new clip through the instrument channel when adjusting the traction direction after the initial clips are anchored. Additional clips must be deployed to manipulate tissue traction, further complicates the internal working space, and inhibits the camera's peripheral vision. The traction achieved is not dynamic. Another drawback is that the traction force weakens during ongoing resection due to the elastic nature of the materials used, especially when the distance between the anchored clips decreases.

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. Previous research has explored various designs of the magnetic element and external magnetic source. While many magnetic traction methods require withdrawing the endoscope to prepare the deployment of magnetic retractor.

Hence, 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. Additionally, a robot-assisted external permanent magnetic source can alleviate the workload of surgeons or assistants on controlling the movement of the EPM for the tissue traction inside patients. Robots assist in translating the heavy EPM with speed and low physical demand. An easily controlled magnetic retractor providing consistent traction force could significantly reduce the procedure time and enhance the process of ESD efficiency. The novel system has potential in reducing the procedure time and reducing the workload of endoscopists. The current pilot study aims to confirm the feasibility and safety of using this robotic magnetic countertraction system for MAG-ESD in patients with gastric and colorectal superficial lesions.

Being tested
MAG-ESD assisted ESD
Keywords
endoscopic submucosal dissection, magnetic retractor
Medical subject headings
Stomach Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MAG-ESD assisted ESDDevice

    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.

Study groups in NCT06962293
Study groupRoleWhat they receive
MAG-ESD assisted ESDExperimentalMagnetic retractor assisted ESD performed
Receives: Device: MAG-ESD assisted ESD

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Technical success rate

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

    Measured: 1 day

Secondary outcomes (18)
  1. Clinical success rate

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

    Measured: 30 days

  2. Total procedure time

    Time taken from injection to completion of resection

    Measured: 1 day

  3. MAG-ESD time

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

    Measured: 1 day

  4. Lesion size

    Lesion size

    Measured: 1day

  5. Lesion location

    Location of the lesion in the GI tract

    Measured: 1 day

  6. NASA task load index

    Endoscopist's NASA-TLX score for the procedure

    Measured: 1 day

  7. Rate of all intraprocedural adverse event

    Intra-procedural adverse event - total

    Measured: 1 day

  8. Rate of intraprocedural adverse event - partial thickness muscle injury

    Partial thickness muscle injury without full thickness perforation

    Measured: 1 day

  9. Rate of intraprocedural adverse event - full thickness perforation

    Full thickness perforation occurring intra-procedure

    Measured: 1 day

  10. Rate of intra-procedural adverse event - haemorrhage

    Major bleeding during procedure causing hemodynamic instability, or require blood transfusion, or causing haemoglobin drop >2g/dL

    Measured: 1 day

  11. Rate of intraprocedural adverse event - other

    Any other intraprocedural adverse event

    Measured: 1 day

  12. Overall rate of Post-procedural adverse event

    All post procedural adverse event

    Measured: 30 days

  13. Rate of Post-procedural adverse event - delayed haemorrhage

    Significant bleeding, with blood loss >2g/dL, or requiring blood transfusion, or causing hemodynamic instability, or requiring re intervention by endoscopy / surgery

    Measured: 30 days

  14. Rate of post-procedural adverse event - delayed perforation

    Delayed perforation occurring after completion of procedure

    Measured: 30 days

  15. Rate of Post-procedural adverse event - post-ESD coagulation syndrome

    Defined by presence of abdominal pain, and fever / leucocytosis after the procedure,

    Measured: 30 days

  16. Rate of post-procedural adverse events - others

    Any other adverse events after the procedure

    Measured: 30 days

  17. Rate of complete resection (R0)

    Resection specimen showing complete resection of the target lesion with negative histological horizontal and vertical margins

    Measured: 30 days

  18. Rate of curative resection

    Curative resection, defined based on Japanese gastroenterological endoscopy society (JGES) guidelines, depending on the tumor locations (Stomach and colorectal)

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2025
  2. Study start9 May 2025 (estimated)
  3. Primary completion30 May 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06962293
Sponsor's protocol ID
CRE-2025.116
Status last verified
Apr 2025
First submitted
30 Apr 2025
Last updated
8 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MAG-ESD assisted ESD in people with Early Gastric Cancer and Colon Neoplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hon Chi Yip, MBChB, FRCSEd (General) (+85235052956, hcyip@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Technical success rate (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in