Endoscopic Submucosal DissectionEarly Phase 1ESDNCT01394861
Endoscopic Submucosal Dissection (ESD)- Master Slave Robotic System - Human Study
A Early Phase 1 study testing ESD using Master Slave Robotic System in people with Endoscopic Submucosal Dissection, run by Asian Institute of Gastroenterology, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Endoscopic Submucosal Dissection
- What is being tested?
- ESD using Master Slave Robotic System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2011to Oct 2011
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -Early Gastric Cancer or Gastric sessile polyp with dysplasia
Who cannot join
- Gastric Cancer with involvement of muscle layer
- Advanced Gastric cancer
Trial locations and contacts
1 site in 1 country.
India1 site
Asian Institute Of Gastroenterology India
Hyderabad, Andhra Pradesh, 500082
About this study
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.
Read the detailed description
Aim:
To evaluate the feasibility and safety of Endoscopic Submucosal Dissection (ESD) using Master Slave Endoscopic Robotic System in humans.
Material and Methods:
To assess the feasibility and safety of ESD in humans, 3 patients with early gastric cancer or sessile polyp in the stomach with no evidence of involvement of deeper layer will be included in the study. The depth of involvement is evaluated by endoscopic ultrasound. An informed consent about the nature of the procedure, complications and the need for surgery will be explained to the patient. The master slave robot system (Human master robotic interface, telesurgical workstation and slave manipulator) and forward viewing therapeutic endoscope with 2 operating channels (GIF -2T160) will be used. The master controller controls the slave manipulator with electrical cables through a software interface. The slave manipulator in turn controls the end effectors (Monopolar 'L' hook and grasper) through cables passed through the two operating channels of the endoscope. The master slave robot system will be set up by the engineers from the Nanyang Technological University, Singapore. The endoscope will be connected to the high definition visual display and will be recorded throughout the procedure. Another high definition monitor will be set up for the surgeon/endoscopist who will control the MASTER at the console and the movements at the console will be continuously recorded. Monopolar electrocautery (ERBE) will be set up and tested. The settings for cutting and blend will be the same as used in the conventional ESD.
The therapeutic endoscope and the end effectors will be sterilised by immersing the scope in glutaraldehyde for 30 minutes before the procedure.
Patient will be kept fasting for 8 hours before the procedure. Under IV sedation, with the patient in left lateral position, end viewing diagnostic gastroscope is passed with an overtube. The lesion will be identified. Then the lesion will be marked by electrocautery (ERBE) all around. Then Gelofusine® (containing 4% succinylated gelatin, sodium hydroxide) stained with methylene blue will be injected submucosally under the lesion to create a cushion for ESD. Then IT knife is used for the mucosal cut all around the lesion. The double channel endoscope (GIF 2T160) will be exchanged through the overtube for the conventional endoscope after checking the system. Then submucosal dissection of the lesion will be performed, using the Master.
The data will be captured in the standard proforma for each patient. The endoscopic view and the external view of the MASTER will be recorded throughout the procedure.
Analysis - Efficacy and Safety outcomes:
The ease of the procedure (grasping, retraction, triangulation and complete excision), time required for mucosal cutting and submucosal dissection and completeness of the procedure will be analysed. Safety outcomes include intraoperative, immediate postoperative complications (bleeding, perforation) and the need for laparotomy will be assessed. Delayed Complications if any will be recorded for up to 30 days after the procedure.
Statistical Methodology:
As this is a pilot study, no sample size calculation was done. The aim is to perform the procedure in 3 subjects. Descriptive statistics will be used to describe safety data.
- Conditions
- Endoscopic Submucosal Dissection
- Being tested
- ESD using Master Slave Robotic System
- Keywords
- Endoscopic Submucosal Dissection, ESD, EMR, Early Gastric Cancer, Flexible Endoscopic Robotic System, Master Slave Robot, Ease & Safety of ESD by Flexible Master Slave Robotic System
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESD using Master Slave Robotic SystemDevice
Endoscopic submucosal dissection of early gastric cancer or broad sessile polyp using Master Slave Robotic System
| Study group | Role | What they receive |
|---|---|---|
| ESD using MASTER Slave Robotic System | Experimental | Not described Receives: Device: ESD using Master Slave Robotic System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ease of the procedure
The ease of the procedure (grasping, retraction, triangulation), time required for mucosal cutting and submucosal dissection
Measured: 30 days
Secondary outcomes (3)
Completeness of the Procedure
Completeness of the procedure is evaluated during the procedure by endoscopy and gross examination of the resected specimen followed by histopathological examination.
Measured: 30 days
Immediate Procedure Related Complications
Bleeding or Perforation during and immediately after the procedure
Measured: 30 days
Delayed Procedure Related Complications
Any complications (Delayed Bleeding or Perforation) related to the procedure up to thirty days post procedure.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionJul 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endoscopic Submucosal DissectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University
- Responsible party
- Sponsor
- Investigators
- Nageshwar Reddy Duvvuru, MD, DM, DSc, FAMS, FRCP, Principal investigator, Asian Institute of Gastroenterology, IndiaLouis Soo Jay Phee, BEng, MEng, PhD, Principal investigator, Nanyang Technological University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394861
- Sponsor's protocol ID
- AIG-GI2011-04
- Acronym
- ESD
- Status last verified
- Mar 2012
- First submitted
- 12 Jul 2011
- Last updated
- 6 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Submucosal Dissection (ESD)- Master Slave Robotic System - Human Study
- ClinicalTrials.gov ID
- NCT01394861
- Acronym / sponsor ID
- ESD / AIG-GI2011-04
- Conditions
- Endoscopic Submucosal Dissection
- Keywords
- Endoscopic Submucosal Dissection, ESD, EMR, Early Gastric Cancer, Flexible Endoscopic Robotic System, Master Slave Robot, Ease & Safety of ESD by Flexible Master Slave Robotic System
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Asian Institute of Gastroenterology, IndiaUniversity, hospital or other
- Collaborators
- Nanyang Technological University
- Study start
- Jun 2011
- Primary completion
- Jul 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 15 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Aim:
To evaluate the feasibility and safety of Endoscopic Submucosal Dissection (ESD) using Master Slave Endoscopic Robotic System in humans.
Material and Methods:
To assess the feasibility and safety of ESD in humans, 3 patients with early gastric cancer or sessile polyp in the stomach with no evidence of involvement of deeper layer will be included in the study. The depth of involvement is evaluated by endoscopic ultrasound. An informed consent about the nature of the procedure, complications and the need for surgery will be explained to the patient. The master slave robot system (Human master robotic interface, telesurgical workstation and slave manipulator) and forward viewing therapeutic endoscope with 2 operating channels (GIF -2T160) will be used. The master controller controls the slave manipulator with electrical cables through a software interface. The slave manipulator in turn controls the end effectors (Monopolar 'L' hook and grasper) through cables passed through the two operating channels of the endoscope. The master slave robot system will be set up by the engineers from the Nanyang Technological University, Singapore. The endoscope will be connected to the high definition visual display and will be recorded throughout the procedure. Another high definition monitor will be set up for the surgeon/endoscopist who will control the MASTER at the console and the movements at the console will be continuously recorded. Monopolar electrocautery (ERBE) will be set up and tested. The settings for cutting and blend will be the same as used in the conventional ESD.
The therapeutic endoscope and the end effectors will be sterilised by immersing the scope in glutaraldehyde for 30 minutes before the procedure.
Patient will be kept fasting for 8 hours before the procedure. Under IV sedation, with the patient in left lateral position, end viewing diagnostic gastroscope is passed with an overtube. The lesion will be identified. Then the lesion will be marked by electrocautery (ERBE) all around. Then Gelofusine® (containing 4% succinylated gelatin, sodium hydroxide) stained with methylene blue will be injected submucosally under the lesion to create a cushion for ESD. Then IT knife is used for the mucosal cut all around the lesion. The double channel endoscope (GIF 2T160) will be exchanged through the overtube for the conventional endoscope after checking the system. Then submucosal dissection of the lesion will be performed, using the Master.
The data will be captured in the standard proforma for each patient. The endoscopic view and the external view of the MASTER will be recorded throughout the procedure.
Analysis - Efficacy and Safety outcomes:
The ease of the procedure (grasping, retraction, triangulation and complete excision), time required for mucosal cutting and submucosal dissection and completeness of the procedure will be analysed. Safety outcomes include intraoperative, immediate postoperative complications (bleeding, perforation) and the need for laparotomy will be assessed. Delayed Complications if any will be recorded for up to 30 days after the procedure.
Statistical Methodology:
As this is a pilot study, no sample size calculation was done. The aim is to perform the procedure in 3 subjects. Descriptive statistics will be used to describe safety data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ESD using MASTER Slave Robotic System | Experimental | Device: ESD using Master Slave Robotic System |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- -Early Gastric Cancer or Gastric sessile polyp with dysplasia
Key exclusion criteria (2 listed)
- Gastric Cancer with involvement of muscle layer
- Advanced Gastric cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ESD using Master Slave Robotic SystemEndoscopic submucosal dissection of early gastric cancer or broad sessile polyp using Master Slave Robotic System | Device | ESD using MASTER Slave Robotic System |
Primary outcome
Ease of the procedure
Time frame: 30 days
The ease of the procedure (grasping, retraction, triangulation), time required for mucosal cutting and submucosal dissection
3 secondary outcomes
Completeness of the Procedure
Time frame: 30 days
Immediate Procedure Related Complications
Time frame: 30 days
Delayed Procedure Related Complications
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nageshwar Reddy Duvvuru, MD, DM, DSc, FAMS, FRCP principal investigator
Asian Institute of Gastroenterology, India
Louis Soo Jay Phee, BEng, MEng, PhD principal investigator
Nanyang Technological University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ESD using Master Slave Robotic System in people with Endoscopic Submucosal Dissection, run by Asian Institute of Gastroenterology, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ease of the procedure (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2012.