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

NCT ID: NCT01464918

Last Updated: 2011-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2012-12-31

Brief Summary

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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

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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

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Gastric Cancer Colon Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ESD using the MASTER device

Endoscopic submucosal dissection of gastric/colon cancer using the device, MASTER

Group Type EXPERIMENTAL

Endoscopic submucosal dissection (ESD) using device, MASTER

Intervention Type DEVICE

Performing endoscopic submucosal dissection (ESD)of the gastric/colon cancer using the device, MASTER

Interventions

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Endoscopic submucosal dissection (ESD) using device, MASTER

Performing endoscopic submucosal dissection (ESD)of the gastric/colon cancer using the device, MASTER

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prince of Wales Hospital, Shatin, Hong Kong

OTHER

Sponsor Role collaborator

Apollo Gleneagles Hospitals, Kolkata

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Khek Yu Ho, MBBS; MD

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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Prince of Wales Hospital

Shatin, Hong Kong, China

Site Status

Apollo Gleneagles Hospitals

Kolkata, , India

Site Status

National University Hospital

Singapore, , Singapore

Site Status

Countries

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China India Singapore

Central Contacts

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Khek Yu Ho, MBBS; MD

Role: CONTACT

[email protected]
65-67726439

Facility Contacts

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Philip Chiu, MBChB; MD

Role: primary

[email protected]
(852) 2632 2627

Mahesh Kumar Goenka, M.D; D.M.

Role: primary

[email protected]
+91-33-23203040 ext. 247 / 251

Khek Yu Ho, M.D.

Role: primary

[email protected]
65-67726439

References

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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.

Reference Type BACKGROUND
PMID: 22029463 (View on PubMed)

Sun 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.

Reference Type BACKGROUND
PMID: 21678013 (View on PubMed)

Ho 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.

Reference Type BACKGROUND
PMID: 20646698 (View on PubMed)

Phee 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.

Reference Type BACKGROUND
PMID: 19963992 (View on PubMed)

Phee 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.

Reference Type BACKGROUND
PMID: 18314917 (View on PubMed)

Phee 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.

Reference Type BACKGROUND
PMID: 20177915 (View on PubMed)

Other Identifiers

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E11/058

Identifier Type: -

Identifier Source: org_study_id