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

National University Health System (NUHS)

Status

Unknown

Conditions

Gastric Cancer

Colon Cancer

Treatments

Device: Endoscopic submucosal dissection (ESD) using device, MASTER

Study type

Interventional

Funder types

Other

Identifiers

NCT01464918

E11/058

Details and patient eligibility

About

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.

Full description

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.

Enrollment

7 estimated patients

Sex

All

Ages

21 to 65 years old

Volunteers

No Healthy Volunteers

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