Safety and Efficacy of Using MASTER to Perform Endoscopic Submucosal Dissection in Human
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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 |
- 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
- 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 |
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| Contact: Khek Yu Ho, MBBS; MD | 65-67726439 | mdchoky@nus.edu.sg |
| 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 | |
| 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 May 21, 2013