Safety and Efficacy of Using MASTER to Perform Endoscopic Submucosal Dissection in Human
Conditions
Gastric Cancer - Colon Cancer
Conditions: official terms
Stomach Neoplasms
Conditions: Keywords
gastric cancer, colon cancer, endoscopic submucosal dissection
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Endoscopic submucosal dissection (ESD) using device, MASTER
Type: Device
Overall Status
Not yet recruiting
Summary
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
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 21 Years
Gender: Both
Criteria: 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
Locations
Prince of Wales Hospital
Shatin, Hong Kong, China
Status: Not yet recruiting
Contact: Philip Chiu, MBChB; MD - (852) 2632 2627 - philipchiu@surgery.cuhk.edu.hk
Apollo Gleneagles Hospitals
Kolkata, India
Status: Not yet recruiting
Contact: Mahesh Kumar Goenka, M.D; D.M. - +91-33-23203040 - mkgkolkata@gmail.com
National University Hospital
Singapore, Singapore
Status: Not yet recruiting
Contact: Khek Yu Ho, M.D. - 65-67726439 - mdchoky@nus.edu.sg
Start Date
November 2011
Completion Date
December 2012
Sponsors
National University Hospital, Singapore
Source
National University Hospital, Singapore
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page