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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Performing endoscopic submucosal dissection (ESD)of the gastric/colon cancer using the device, MASTER
Prince of Wales Hospital
Shatin, Hong Kong, China
Apollo Gleneagles Hospitals
Kolkata, India
National University Hospital
Singapore, Singapore
Total time taken to complete the ESD procedure
The total time spent from docking of MASTER to end of submucosal dissection
Time frame: Participants will be followed for the duration of the operation, an expected average of 3 hours
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".
Time frame: 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.
Time frame: From start of operation of the ESD procedure, assessed up to 7 days after the procedure
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