Status:

UNKNOWN

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

Lead Sponsor:

National University Hospital, Singapore

Collaborating Sponsors:

Prince of Wales Hospital, Shatin, Hong Kong

Apollo Gleneagles Hospitals, Kolkata

Conditions:

Gastric Cancer

Colon Cancer

Eligibility:

All Genders

21-65 years

Phase:

NA

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.

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2012

Estimated Enrollment :

7 Patients enrolled

Trial Details

Trial ID

NCT01464918

Start Date

November 1 2011

End Date

December 1 2012

Last Update

November 4 2011

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Prince of Wales Hospital

Shatin, Hong Kong, China

2

Apollo Gleneagles Hospitals

Kolkata, India, 700054

3

National University Hospital

Singapore, Singapore, 119074