Safety and Efficacy of Using MASTER to Perform Endoscopic Submucosal Dissection in Human
1 other identifier
interventional
7
3 countries
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable gastric-cancer
Started Nov 2011
Shorter than P25 for not_applicable gastric-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedFirst Posted
Study publicly available on registry
November 4, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedNovember 4, 2011
October 1, 2011
1.1 years
October 30, 2011
November 1, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Total time taken to complete the ESD procedure
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 Outcomes (2)
Measure of ease of performing the ESD procedure
Participants will be followed for the duration of the operation, an expected average of 3 hours
Safety
From start of operation of the ESD procedure, assessed up to 7 days after the procedure
Study Arms (1)
ESD using the MASTER device
EXPERIMENTALEndoscopic submucosal dissection of gastric/colon cancer using the device, MASTER
Interventions
Performing endoscopic submucosal dissection (ESD)of the gastric/colon cancer using the device, MASTER
Eligibility Criteria
You may qualify if:
- patient diagnosed with early gastric or colon cancer, is deemed suitable to undergo endoscopic submucosal dissection and is able/willing to give informed consent.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Prince of Wales Hospital
Shatin, Hong Kong, China
Apollo Gleneagles Hospitals
Kolkata, 700054, India
National University Hospital
Singapore, 119074, Singapore
Related Publications (6)
Phee SJ, Sun Z, Wang Z, Wong JY, Ho KY. The future of transluminal surgery. Expert Rev Med Devices. 2011 Nov;8(6):669-71. doi: 10.1586/erd.11.54. No abstract available.
PMID: 22029463BACKGROUNDSun Z, Ang RY, Lim EW, Wang Z, Ho KY, Phee SJ. Enhancement of a master-slave robotic system for natural orifice transluminal endoscopic surgery. Ann Acad Med Singap. 2011 May;40(5):223-30.
PMID: 21678013BACKGROUNDHo KY, Phee SJ, Shabbir A, Low SC, Huynh VA, Kencana AP, Yang K, Lomanto D, So BY, Wong YY, Chung SC. Endoscopic submucosal dissection of gastric lesions by using a Master and Slave Transluminal Endoscopic Robot (MASTER). Gastrointest Endosc. 2010 Sep;72(3):593-9. doi: 10.1016/j.gie.2010.04.009. Epub 2010 Jun 19.
PMID: 20646698BACKGROUNDPhee SJ, Low SC, Huynh VA, Kencana AP, Sun ZL, Yang K. Master and slave transluminal endoscopic robot (MASTER) for natural orifice transluminal endoscopic surgery (NOTES). Annu Int Conf IEEE Eng Med Biol Soc. 2009;2009:1192-5. doi: 10.1109/IEMBS.2009.5333413.
PMID: 19963992BACKGROUNDPhee SJ, Low SC, Sun ZL, Ho KY, Huang WM, Thant ZM. Robotic system for no-scar gastrointestinal surgery. Int J Med Robot. 2008 Mar;4(1):15-22. doi: 10.1002/rcs.179.
PMID: 18314917BACKGROUNDPhee SJ, Ho KY, Lomanto D, Low SC, Huynh VA, Kencana AP, Yang K, Sun ZL, Chung SC. Natural orifice transgastric endoscopic wedge hepatic resection in an experimental model using an intuitively controlled master and slave transluminal endoscopic robot (MASTER). Surg Endosc. 2010 Sep;24(9):2293-8. doi: 10.1007/s00464-010-0955-8. Epub 2010 Feb 23.
PMID: 20177915BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Khek Yu Ho, MBBS; MD
National University Hospital, Singapore
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2011
First Posted
November 4, 2011
Study Start
November 1, 2011
Primary Completion
December 1, 2012
Study Completion
December 1, 2012
Last Updated
November 4, 2011
Record last verified: 2011-10