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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01464918
Recruitment Status : Unknown
Verified October 2011 by National University Hospital, Singapore.
Recruitment status was:  Not yet recruiting
First Posted : November 4, 2011
Last Update Posted : November 4, 2011
Sponsor:
Collaborators:
Prince of Wales Hospital, Shatin, Hong Kong
Apollo Gleneagles Hospitals, Kolkata
Information provided by (Responsible Party):
National University Hospital, Singapore

Tracking Information
First Submitted Date  ICMJE October 30, 2011
First Posted Date  ICMJE November 4, 2011
Last Update Posted Date November 4, 2011
Study Start Date  ICMJE November 2011
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2011)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2011)
  • 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".
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Using MASTER to Perform Endoscopic Submucosal Dissection in Human
Official Title  ICMJE Safety and Efficacy of Using MASTER, a Novel Robotics Enhanced Endosurgical System to Perform Endoscopic Submucosal Dissection in Human
Brief 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastric Cancer
  • Colon Cancer
Intervention  ICMJE Device: Endoscopic submucosal dissection (ESD) using device, MASTER
Performing endoscopic submucosal dissection (ESD)of the gastric/colon cancer using the device, MASTER
Study Arms  ICMJE Experimental: ESD using the MASTER device
Endoscopic submucosal dissection of gastric/colon cancer using the device, MASTER
Intervention: Device: Endoscopic submucosal dissection (ESD) using device, MASTER
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 1, 2011)
7
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China,   India,   Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01464918
Other Study ID Numbers  ICMJE E11/058
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE
  • Prince of Wales Hospital, Shatin, Hong Kong
  • Apollo Gleneagles Hospitals, Kolkata
Investigators  ICMJE
Principal Investigator: Khek Yu Ho, MBBS; MD National University Hospital, Singapore
PRS Account National University Hospital, Singapore
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP