Safety and Efficacy of Using MASTER, a Novel Robotics Enhanced Endosurgical System to Perform Endoscopic Submucosal Dissection 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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
No
Khek Yu Ho, MBBS; MD
Principal Investigator
National University Hospital, Singapore
Singapore: Domain Specific Review Boards
E11/058
NCT01464918
November 2011
December 2012
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