Colon Cancer, Gastric Cancer
Conditions
Keywords
gastric cancer, colon cancer, endoscopic submucosal dissection
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 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.
Interventions
DEVICEEndoscopic submucosal dissection (ESD) using device, MASTER
Performing endoscopic submucosal dissection (ESD)of the gastric/colon cancer using the device, MASTER
Sponsors
Prince of Wales Hospital, Shatin, Hong Kong
Apollo Gleneagles Hospitals, Kolkata
National University Hospital, Singapore
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total time taken to complete the ESD procedure | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of ease of performing the ESD procedure | Participants will be followed for the duration of the operation, an expected average of 3 hours | Measure ease of grasping, retraction, and triangulation of robotics end-effectors during the ESD procedure. Measures are rated as excellent, good, or poor. |
| Safety | From start of operation of the ESD procedure, assessed up to 7 days after the procedure | Any procedure-related complications that occurs from start ofthe ESD procedure up to 7 days after the procedure. |
Countries
China, India, Singapore
Contacts
Primary ContactKhek Yu Ho, MBBS; MD
Outcome results
None listed