Gastric CancerNCT01464918
Safety and Efficacy of Using MASTER to Perform Endoscopic Submucosal Dissection in Human
A study testing Endoscopic submucosal dissection (ESD) using device, MASTER in people with Gastric Cancer and Colon Cancer, run by National University Hospital, Singapore at 3 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Gastric Cancer, Colon Cancer
- What is being tested?
- Endoscopic submucosal dissection (ESD) using device, MASTER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Nov 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient diagnosed with early gastric or colon cancer, is deemed suitable to undergo endoscopic submucosal dissection and is able/willing to give informed consent.
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
China1 site
Prince of Wales Hospital
Shatin, Hong Kong
Philip Chiu, MBChB; MD, (852) 2632 2627, philipchiu@surgery.cuhk.edu.hk
Philip Chiu, MBChB; MD
India1 site
Apollo Gleneagles Hospitals
Kolkata, 700054
Mahesh Kumar Goenka, M.D; D.M., +91-33-23203040 ext. 247 / 251, mkgkolkata@gmail.com
Mahesh Kumar Goenka, MD; DM
Singapore1 site
National University Hospital
Singapore, 119074
Khek Yu Ho, M.D., 65-67726439, mdchoky@nus.edu.sg
Khek Yu Ho, MBBS; MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer, Colon Cancer
- Being tested
- Endoscopic submucosal dissection (ESD) using device, MASTER
- Keywords
- gastric cancer, colon cancer, endoscopic submucosal dissection
- Medical subject headings
- Stomach Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic submucosal dissection (ESD) using device, MASTERDevice
Performing endoscopic submucosal dissection (ESD)of the gastric/colon cancer using the device, MASTER
| Study group | Role | What they receive |
|---|---|---|
| ESD using the MASTER device | Experimental | Endoscopic submucosal dissection of gastric/colon cancer using the device, MASTER Receives: Device: Endoscopic submucosal dissection (ESD) using device, MASTER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time taken to complete the ESD procedure
The total time spent from docking of MASTER to end of submucosal dissection
Measured: 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
Measure ease of grasping, retraction, and triangulation of robotics end-effectors during the ESD procedure. Measures are rated as "excellent, good, or poor".
Measured: Participants will be followed for the duration of the operation, an expected average of 3 hours
Safety
Any procedure-related complications that occurs from start ofthe ESD procedure up to 7 days after the procedure.
Measured: From start of operation of the ESD procedure, assessed up to 7 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Apollo Gleneagles Hospitals, Kolkata
- Responsible party
- Sponsor
- Investigators
- Khek Yu Ho, MBBS; MD, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01464918
- Sponsor's protocol ID
- E11/058
- Status last verified
- Oct 2011
- First submitted
- 30 Oct 2011
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22029463Sun 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.
PubMed 21678013Ho 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.
PubMed 20646698Phee 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.
PubMed 19963992Phee 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.
PubMed 18314917Phee 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.
PubMed 20177915
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Using MASTER, a Novel Robotics Enhanced Endosurgical System to Perform Endoscopic Submucosal Dissection in Human
- ClinicalTrials.gov ID
- NCT01464918
- Acronym / sponsor ID
- E11/058
- Conditions
- Gastric Cancer, Colon Cancer
- Keywords
- gastric cancer, colon cancer, endoscopic submucosal dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- Prince of Wales Hospital, Shatin, Hong Kong, Apollo Gleneagles Hospitals, Kolkata
- Study start
- Nov 2011
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 4 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESD using the MASTER device | Experimental | Device: Endoscopic submucosal dissection (ESD) using device, MASTEREndoscopic submucosal dissection of gastric/colon cancer using the device, MASTER |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patient diagnosed with early gastric or colon cancer, is deemed suitable to undergo endoscopic submucosal dissection and is able/willing to give informed consent.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic submucosal dissection (ESD) using device, MASTERPerforming endoscopic submucosal dissection (ESD)of the gastric/colon cancer using the device, MASTER | Device | ESD using the MASTER device |
Primary outcome
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
2 secondary outcomes
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
Safety
Time frame: From start of operation of the ESD procedure, assessed up to 7 days after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
- Background: PubMed 22029463Phee 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.
- Background: PubMed 21678013Sun 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.
- Background: PubMed 20646698Ho 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.
- Background: PubMed 19963992Phee 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.
- Background: PubMed 18314917Phee 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.
- Background: PubMed 20177915Phee 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khek Yu Ho, MBBS; MD principal investigator
National University Hospital, Singapore
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic submucosal dissection (ESD) using device, MASTER in people with Gastric Cancer and Colon Cancer, run by National University Hospital, Singapore at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, India, Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Khek Yu Ho, MBBS; MD (65-67726439, mdchoky@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01464918, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2011.