NCT01394861

Brief Summary

The purpose of this study is to evaluate the feasibility, ease and safety of flexible endoscopic robotic system to treat early gastric cancer in humans.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jun 2011

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 15, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
Last Updated

March 6, 2012

Status Verified

March 1, 2012

Enrollment Period

1 month

First QC Date

July 12, 2011

Last Update Submit

March 4, 2012

Conditions

Endoscopic Submucosal Dissection

Keywords

Endoscopic Submucosal DissectionESDEMREarly Gastric CancerFlexible Endoscopic Robotic SystemMaster Slave RobotEase & Safety of ESD by Flexible Master Slave Robotic System

Outcome Measures

Primary Outcomes (1)

  • Ease of the procedure

    The ease of the procedure (grasping, retraction, triangulation), time required for mucosal cutting and submucosal dissection

    30 days

Secondary Outcomes (3)

  • Completeness of the Procedure

    30 days

  • Immediate Procedure Related Complications

    30 days

  • Delayed Procedure Related Complications

    30 days

Study Arms (1)

ESD using MASTER Slave Robotic System

EXPERIMENTAL
Device: ESD using Master Slave Robotic System

Interventions

ESD using Master Slave Robotic SystemDEVICE

Endoscopic submucosal dissection of early gastric cancer or broad sessile polyp using Master Slave Robotic System

ESD using MASTER Slave Robotic System

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Early Gastric Cancer or Gastric sessile polyp with dysplasia

You may not qualify if:

  • Gastric Cancer with involvement of muscle layer
  • Advanced Gastric cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asian Institute Of Gastroenterology India

Hyderabad, Andhra Pradesh, 500082, India

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Nageshwar Reddy Duvvuru, MD, DM, DSc, FAMS, FRCP

    Asian Institute of Gastroenterology, India

    PRINCIPAL INVESTIGATOR

  • Louis Soo Jay Phee, BEng, MEng, PhD

    Nanyang Technological University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2011

First Posted

July 15, 2011

Study Start

June 1, 2011

Primary Completion

July 1, 2011

Study Completion

October 1, 2011

Last Updated

March 6, 2012

Record last verified: 2012-03

Locations

IN(1)