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.
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.
Hong Kong1 site, 1 recruiting
- 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
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.
- Conditions
- Early Gastric Cancer, Colon Neoplasia
- 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 group | Role | What they receive |
|---|---|---|
| MAG-ESD assisted ESD | Experimental | Magnetic 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.
Technical success rate
Successful en-bloc, without major intra-operative adverse event.
Measured: 1 day
Secondary outcomes (18)
Clinical success rate
pathological R0 resection, without major intra-operative and post-operative adverse event.
Measured: 30 days
Total procedure time
Time taken from injection to completion of resection
Measured: 1 day
MAG-ESD time
Time taken to apply the magnetic traction from introduction of magnetic retractor to the actual countertraction in effect
Measured: 1 day
Lesion size
Lesion size
Measured: 1day
Lesion location
Location of the lesion in the GI tract
Measured: 1 day
NASA task load index
Endoscopist's NASA-TLX score for the procedure
Measured: 1 day
Rate of all intraprocedural adverse event
Intra-procedural adverse event - total
Measured: 1 day
Rate of intraprocedural adverse event - partial thickness muscle injury
Partial thickness muscle injury without full thickness perforation
Measured: 1 day
Rate of intraprocedural adverse event - full thickness perforation
Full thickness perforation occurring intra-procedure
Measured: 1 day
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
Rate of intraprocedural adverse event - other
Any other intraprocedural adverse event
Measured: 1 day
Overall rate of Post-procedural adverse event
All post procedural adverse event
Measured: 30 days
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
Rate of post-procedural adverse event - delayed perforation
Delayed perforation occurring after completion of procedure
Measured: 30 days
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
Rate of post-procedural adverse events - others
Any other adverse events after the procedure
Measured: 30 days
Rate of complete resection (R0)
Resection specimen showing complete resection of the target lesion with negative histological horizontal and vertical margins
Measured: 30 days
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.
- First posted8 May 2025
- Study start9 May 2025 (estimated)
- Primary completion30 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Gastric CancerStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hon Chi Yip, Chinese University of Hong Kong
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Anchor Guided - Endoscopic Submucosal Dissection (MAG-ESD) for Gastric and Colorectal Superficial Lesions - a Pilot Study
- ClinicalTrials.gov ID
- NCT06962293
- Acronym / sponsor ID
- CRE-2025.116
- Conditions
- Early Gastric Cancer, Colon Neoplasia
- Keywords
- endoscopic submucosal dissection, magnetic retractor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 9 May 2025 (estimated)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAG-ESD assisted ESD | Experimental | Device: MAG-ESD assisted ESDMagnetic retractor assisted ESD performed |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with superficial gastric or colorectal lesions, scheduled for endoscopic submucosal dissection (ESD).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAG-ESD assisted ESDFlexible 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. | Device | MAG-ESD assisted ESD |
Primary outcome
Technical success rate
Time frame: 1 day
Successful en-bloc, without major intra-operative adverse event.
18 secondary outcomes
Clinical success rate
Time frame: 30 days
Total procedure time
Time frame: 1 day
MAG-ESD time
Time frame: 1 day
Lesion size
Time frame: 1day
Lesion location
Time frame: 1 day
NASA task load index
Time frame: 1 day
Rate of all intraprocedural adverse event
Time frame: 1 day
Rate of intraprocedural adverse event - partial thickness muscle injury
Time frame: 1 day
Rate of intraprocedural adverse event - full thickness perforation
Time frame: 1 day
Rate of intra-procedural adverse event - haemorrhage
Time frame: 1 day
Rate of intraprocedural adverse event - other
Time frame: 1 day
Overall rate of Post-procedural adverse event
Time frame: 30 days
Rate of Post-procedural adverse event - delayed haemorrhage
Time frame: 30 days
Rate of post-procedural adverse event - delayed perforation
Time frame: 30 days
Rate of Post-procedural adverse event - post-ESD coagulation syndrome
Time frame: 30 days
Rate of post-procedural adverse events - others
Time frame: 30 days
Rate of complete resection (R0)
Time frame: 30 days
Rate of curative resection
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.