---
title: Safety and Efficacy of Using MASTER to Perform Endoscopic Submucosal Dissection in Human
nct_id: NCT01464918
overall_status: UNKNOWN
phase: NA
sponsor: National University Hospital, Singapore
study_type: INTERVENTIONAL
primary_condition: Gastric Cancer
countries: China, India, Singapore
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01464918.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01464918"
ct_last_update_post_date: 2011-11-04
last_seen_at: "2026-05-12T06:05:25.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Safety and Efficacy of Using MASTER to Perform Endoscopic Submucosal Dissection in Human

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

**NCT ID:** [NCT01464918](https://clinicaltrials.gov/study/NCT01464918)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 7
- **Lead Sponsor:** National University Hospital, Singapore
- **Collaborators:** Prince of Wales Hospital, Shatin, Hong Kong, Apollo Gleneagles Hospitals, Kolkata
- **Conditions:** Gastric Cancer, Colon Cancer
- **Start Date:** 2011-11
- **Completion Date:** 2012-12
- **CT.gov Last Update:** 2011-11-04

## 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.

## Eligibility

- **Minimum age:** 21 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **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
```

## Arms

- **ESD using the MASTER device** (EXPERIMENTAL) — Endoscopic submucosal dissection of gastric/colon cancer using the device, MASTER

## Interventions

- **Endoscopic submucosal dissection (ESD) using device, MASTER** (DEVICE) — Performing endoscopic submucosal dissection (ESD)of the gastric/colon cancer using the device, MASTER

## Primary Outcomes

- **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

## 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)_

## Locations (3)

- Prince of Wales Hospital, Shatin, Hong Kong, China
- Apollo Gleneagles Hospitals, Kolkata, India
- National University Hospital, Singapore, Singapore

## Recent Field Changes (last 30 days)

- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.prince of wales hospital|shatin|hong kong|china` — added _(2026-05-12)_
- `locations.apollo gleneagles hospitals|kolkata||india` — added _(2026-05-12)_
- `locations.national university hospital|singapore||singapore` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT01464918*  
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