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

Gastric Cancer Clinical Trial

Official title:

Safety and Efficacy of Using MASTER, a Novel Robotics Enhanced Endosurgical System to Perform Endoscopic Submucosal Dissection in Human

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01464918
• Other study ID #: E11/058
• Status: Unknown status
• Phase: N/A
• First received: October 30, 2011
• Last updated: November 1, 2011
• Start date: November 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2011
• Source: National University Hospital, Singapore
• Contact: Khek Yu Ho, MBBS; MD
• Phone: 65-67726439
• Email: mdchoky[@]nus.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 7
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Gastric Cancer
• Stomach Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Prince of Wales Hospital	Shatin	Hong Kong
India	Apollo Gleneagles Hospitals	Kolkata
Singapore	National University Hospital	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
National University Hospital, Singapore	Apollo Gleneagles Hospitals, Kolkata, Prince of Wales Hospital, Shatin, Hong Kong

Countries where clinical trial is conducted

China,  India,  Singapore, 

References & Publications (6)

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. — View Citation

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. — View Citation

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). Conf Proc IEEE Eng Med Biol Soc. 2009;2009:1192-5. doi: 10.1109/IEMBS.2009.5333413. — View Citation

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. — View Citation

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. Review. — View Citation

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 Singapore. 2011 May;40(5):223-30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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".	Participants will be followed for the duration of the operation, an expected average of 3 hours
Secondary	Safety	Any procedure-related complications that occurs from start ofthe ESD procedure up to 7 days after the procedure.	From start of operation of the ESD procedure, assessed up to 7 days after the procedure