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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by National University Hospital, Singapore.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Prince of Wales Hospital, Shatin, Hong Kong
Apollo Gleneagles Hospitals, Kolkata
Information provided by (Responsible Party):
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01464918
First received: October 30, 2011
Last updated: November 1, 2011
Last verified: October 2011
  Purpose

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.


Condition Intervention
Gastric Cancer
Colon Cancer
Device: Endoscopic submucosal dissection (ESD) using device, MASTER

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Using MASTER, a Novel Robotics Enhanced Endosurgical System to Perform Endoscopic Submucosal Dissection in Human

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Total time taken to complete the ESD procedure [ Time Frame: Participants will be followed for the duration of the operation, an expected average of 3 hours ] [ Designated as safety issue: No ]
    The total time spent from docking of MASTER to end of submucosal dissection


Secondary Outcome Measures:
  • Measure of ease of performing the ESD procedure [ Time Frame: Participants will be followed for the duration of the operation, an expected average of 3 hours ] [ Designated as safety issue: No ]
    Measure ease of grasping, retraction, and triangulation of robotics end-effectors during the ESD procedure. Measures are rated as "excellent, good, or poor".

  • Safety [ Time Frame: From start of operation of the ESD procedure, assessed up to 7 days after the procedure ] [ Designated as safety issue: Yes ]
    Any procedure-related complications that occurs from start ofthe ESD procedure up to 7 days after the procedure.


Estimated Enrollment: 7
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ESD using the MASTER device
Endoscopic submucosal dissection of gastric/colon cancer using the device, MASTER
Device: Endoscopic submucosal dissection (ESD) using device, MASTER
Performing endoscopic submucosal dissection (ESD)of the gastric/colon cancer using the device, MASTER

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464918

Contacts
Contact: Khek Yu Ho, MBBS; MD 65-67726439 mdchoky@nus.edu.sg

Locations
China, Hong Kong
Prince of Wales Hospital Not yet recruiting
Shatin, Hong Kong, China
Contact: Philip Chiu, MBChB; MD    (852) 2632 2627    philipchiu@surgery.cuhk.edu.hk   
Principal Investigator: Philip Chiu, MBChB; MD         
India
Apollo Gleneagles Hospitals Not yet recruiting
Kolkata, India, 700054
Contact: Mahesh Kumar Goenka, M.D; D.M.    +91-33-23203040 ext 247 / 251    mkgkolkata@gmail.com   
Principal Investigator: Mahesh Kumar Goenka, MD; DM         
Singapore
National University Hospital Not yet recruiting
Singapore, Singapore, 119074
Contact: Khek Yu Ho, M.D.    65-67726439    mdchoky@nus.edu.sg   
Principal Investigator: Khek Yu Ho, MBBS; MD         
Sub-Investigator: Bih Shiou Charles Tsang, MBBS; MS         
Sponsors and Collaborators
National University Hospital, Singapore
Prince of Wales Hospital, Shatin, Hong Kong
Apollo Gleneagles Hospitals, Kolkata
Investigators
Principal Investigator: Khek Yu Ho, MBBS; MD National University Hospital, Singapore
  More Information

Publications:
Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT01464918     History of Changes
Other Study ID Numbers: E11/058
Study First Received: October 30, 2011
Last Updated: November 1, 2011
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
gastric cancer
colon cancer
endoscopic submucosal dissection

Additional relevant MeSH terms:
Colonic Neoplasms
Stomach Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Stomach Diseases

ClinicalTrials.gov processed this record on July 29, 2014