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

November 1, 2011 updated by: National University Hospital, Singapore

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 robotics enhanced endosurgical system to perform endoscopic submucosal dissection (ESD) of gastric/colon cancer in human.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hong Kong
      • Shatin, Hong Kong, China
        • Prince of Wales Hospital
        • Contact:
        • Principal Investigator:
          • Philip Chiu, MBChB; MD
  • India
      • Kolkata, India, 700054
        • Apollo Gleneagles Hospitals
        • Contact:
          • Mahesh Kumar Goenka, M.D; D.M.
          • Phone Number: 247 / 251 +91-33-23203040
          • Email: mkgkolkata@gmail.com
        • Principal Investigator:
          • Mahesh Kumar Goenka, MD; DM
  • Singapore
      • Singapore, Singapore, 119074
        • National University Hospital
        • Contact:
        • Principal Investigator:
          • Khek Yu Ho, MBBS; MD
        • Sub-Investigator:
          • Bih Shiou Charles Tsang, MBBS; MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measure ease of grasping, retraction, and triangulation of robotics end-effectors during the ESD procedure. Measures are rated as "excellent, good, or poor".
Participants will be followed for the duration of the operation, an expected average of 3 hours
Safety
Time Frame: From start of operation of the ESD procedure, assessed up to 7 days after the procedure
Any procedure-related complications that occurs from start ofthe ESD procedure up to 7 days after the procedure.
From start of operation of the ESD procedure, assessed up to 7 days after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

Prince of Wales Hospital, Shatin, Hong Kong
Apollo Gleneagles Hospitals, Kolkata

Investigators

  • Principal Investigator: Khek Yu Ho, MBBS; MD, National University Hospital, Singapore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

October 30, 2011

First Submitted That Met QC Criteria

November 1, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Estimate)

November 4, 2011

Last Update Submitted That Met QC Criteria

November 1, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E11/058

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer

Clinical Trials on Endoscopic submucosal dissection (ESD) using device, MASTER

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe