Safety and Efficacy of Using MASTER to Perform Endoscopic Submucosal Dissection in Human

Study Overview
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Brief Summary
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This trial is to evaluate the safety and efficacy of using MASTER, a robotics enhanced endosurgical system to perform endoscopic submucosal dissection (ESD) of gastric/colon cancer in human.

Detailed Description
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This trial is to evaluate the safety and efficacy of using MASTER, a novel robotics enhanced endosurgical system to perform endoscopic submucosal dissection (ESD) of gastric/colon cancer in human. The MASTER is a master-and-slave robotic system that is deployed through a standard dual-channel therapeutic endoscope. It introduces robotic control of endoscopic surgical tools and tasks through an ergonomic human-machine interface built around the original endoscopic paradigm. In doing so, it separates control of instrumental motion from that of endoscopic movement such that surgical tasks may be independently executed by a second operator via a human-machine interface. With it, endoscopically deployed instruments can be independently controlled, allowing thus bimanual coordination of effector instruments to facilitate actions such as retraction/exposure, traction/countertraction, approximation and dissection of tissue. Using the MASTER, operational dexterity is increased, thus making it easier for the operator to perform the ESD procedure as compared with using the conventional endoscope. This study will measure the ease of using the MASTER to perform the various surgical tasks involved in the ESD procedure, the time taken to perform the procedure, and record complications, if any, occurred during and after the procedure.

Official Title
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Safety and Efficacy of Using MASTER, a Novel Robotics Enhanced Endosurgical System to Perform Endoscopic Submucosal Dissection in Human

Conditions
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Gastric Cancer, Colon Cancer

Intervention / Treatment
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* Device: Endoscopic submucosal dissection (ESD) using device, MASTER


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient diagnosed with early gastric or colon cancer, is deemed suitable to undergo endoscopic submucosal dissection and is able/willing to give informed consent. Exclusion Criteria: case is deemed not suitable for endoscopic submucosal dissection is on warfarin or other blood thinning agents and those with bleeding disorders has uncorrected coagulopathy or severe thrombocytopenia precluding biopsy has serious co-morbidities such as heart disease, renal impairment and cancer has recently underwent surgery or has a personal history of stomach/colon cancer or surgery is unable/unwilling to give informed consent is pregnant or breast-feeding women patients who cannot undergo gastroscopies

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ESD using the MASTER device<br>Endoscopic submucosal dissection of gastric/colon cancer using the device, MASTER | Device: Endoscopic submucosal dissection (ESD) using device, MASTER<br>* Performing endoscopic submucosal dissection (ESD)of the gastric/colon cancer using the device, MASTER<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time taken to complete the ESD procedure | The total time spent from docking of MASTER to end of submucosal dissection | Participants will be followed for the duration of the operation, an expected average of 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of ease of performing the ESD procedure | Measure ease of grasping, retraction, and triangulation of robotics end-effectors during the ESD procedure. Measures are rated as excellent, good, or poor. | Participants will be followed for the duration of the operation, an expected average of 3 hours | 
| Safety | Any procedure-related complications that occurs from start ofthe ESD procedure up to 7 days after the procedure. | From start of operation of the ESD procedure, assessed up to 7 days after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, colon cancer, endoscopic submucosal dissection