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

21 Years
65 Years
Not Enrolling
Gastric Cancer, Colon Cancer

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Trial Information

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.

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

- is unable/unwilling to give informed consent

- is pregnant or breast-feeding women patients who cannot undergo gastroscopies

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Total time taken to complete the ESD procedure

Outcome Description:

The total time spent from docking of MASTER to end of submucosal dissection

Outcome Time Frame:

Participants will be followed for the duration of the operation, an expected average of 3 hours

Safety Issue:


Principal Investigator

Khek Yu Ho, MBBS; MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

November 2011

Completion Date:

December 2012

Related Keywords:

  • Gastric Cancer
  • Colon Cancer
  • gastric cancer
  • colon cancer
  • endoscopic submucosal dissection
  • Colonic Neoplasms
  • Stomach Neoplasms