Colonic NeoplasmsMASTERCESDNCT04196062
EndoMaster EASE System for Treatment of Colorectal Lesions
A study testing EndoMASTER EASE Robotic system for ESD in people with Colonic Neoplasms, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a prospective, single arm study to assess the safety and performance of the EndoMaster EASE (Endoluminal Access Surgical Efficacy) System for the treatment of patients with colorectal neoplasms. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- EndoMASTER EASE Robotic system for ESD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 May 2020to 31 Dec 2022
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 and ≤ 85;
- Suspected intramucosal neoplasm of the colon or rectum, including adenocarcinoma and tubular, tubulovillous, or villous adenomas.
Who cannot join
- Informed consent not available;
- Carcinoma of colon or rectum with known involvement beyond the submucosa;
- Evidence of distant spread of colon cancer;
- Presence of another active malignancy;
- Pregnancy;
- Patients considered unfit for general anaesthesia;
- The endoscopic platform cannot reach the target site;
- Current participation in another clinical research study.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Combined Endoscopy Center, Prince of Wales Hospital
Hong Kong, 00000
About this study
Official title: Prospective, Single Arm Study to Assess the Safety and Performance of the EndoMaster EASE System for the Treatment of Colorectal Lesions
This is a prospective, single arm study to assess the safety and performance of the EndoMaster EASE (Endoluminal Access Surgical Efficacy) System for the treatment of patients with colorectal neoplasms.
Read the detailed description
Prospective, single arm study to assess the safety and performance of robotically assisted ESD of superficial colorectal lesions, that otherwise cannot be optimally and radically removed by snare-based techniques
- Conditions
- Colonic Neoplasms
- Being tested
- EndoMASTER EASE Robotic system for ESD
- Keywords
- Colonic ESD, Robotic Endoscope
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndoMASTER EASE Robotic system for ESDDevice
EndoMaster EASE System, is a robotic-assisted endoscopy system indicated for endoscopic visualization and therapeutic access to the adult gastrointestinal (GI) tract for endoscopic surgery
| Study group | Role | What they receive |
|---|---|---|
| Robotic ESD | Experimental | Treatment of early colorectal neoplasia / lateral spreading tumors by ESD using EndoMASTER EASE robotic system Receives: Device: EndoMASTER EASE Robotic system for ESD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete (R0) resection
rate of complete (R0) resection defined as en bloc, one-piece resection with histologically confirmed tumour-free lateral and vertical margins
Measured: 30 days
Secondary outcomes (15)
Bleeding during or after the procedure
Bleeding as evidence by
- Active bleeding during the robotic ESD procedure
- Bleeding after ESD with clinical evidence of 1. Fresh hematemesis; 2. Passage of tarry stool with pulse > 100 or systolic blood pressure < 100; 3. Drop in hemoglobin level of > 4 g/dl
Measured: 30 days
Perforation
Perforation at the ESD site as assessed by endoscopy
Measured: 30 days
Adjunctive procedures to control bleeding
Use of coagrapser / clips
Measured: 1 day
All cause mortality
Mortality
Measured: 30 days
Infection
Clinical sepsis with changes in inflammatory markers as evidence by
- clinical symptoms of fever, pulse > 100
- radiological evidence of intraperitoneal collection
- elevated WBC count of > 10.0
Measured: 30 days
Impairment of renal function
renal failure as evidence of derangement of renal function with elevated creatinin level > 100 mmol/l
Measured: 30 days
Serious Adverse Events
Serous Adverse Events at preocedure and through discharge
Measured: 30 days
Duration of procedure
OT time
Measured: 1 day
Operator assessment of device performance
Operator assessment
Measured: 1 day
Device deficiencies
Device malfunction and Use errors during the ESD procedure as evidence by
- cessation of the function of the EndoMASTER EASE system
- need to use of the immediate cessation button for the EndoMASTER EASE system
Measured: 1 day
Length of Hospital stay
Length of Hospital Stay
Measured: 30 days
Histology of resected specimen
En bloc resection rate / R0 rate / positive vertical margin / positive lateral margin
Measured: 30 days
Colonoscopy followup
Healing of operative site / presence of suspicious tissue for biopsy / presence of stricture
Measured: 6 months, 18 months to 3 years
Cancer status by cross-sectional imaging (MRI / CT)
local recurrence / recurrence at different site in colon / metastatic disease and location
Measured: 12 months and 3 years
Technical Success
en bloc, one-piece excision of the neoplasm irrespective of histopathology, in the absence of device-related SAE through 30 days
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 posted12 Dec 2019
- Study start1 May 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, Single-Arm Study
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Wai Yan CHIU, Chinese University of Hong Kong
- Investigators
- Philip Chiu, MD, Study director, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196062
- Sponsor's protocol ID
- CRE Ref. No. 2019.331
- Acronym
- MASTERCESD
- Status last verified
- Nov 2023
- First submitted
- 10 Dec 2019
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm Study to Assess the Safety and Performance of the EndoMaster EASE System for the Treatment of Colorectal Lesions
- ClinicalTrials.gov ID
- NCT04196062
- Acronym / sponsor ID
- MASTERCESD / CRE Ref. No. 2019.331
- Conditions
- Colonic Neoplasms
- Keywords
- Colonic ESD, Robotic Endoscope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 12 Dec 2019 (actual)
- 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.
This is a prospective, single arm study to assess the safety and performance of the EndoMaster EASE (Endoluminal Access Surgical Efficacy) System for the treatment of patients with colorectal neoplasms.
Detailed description
Prospective, single arm study to assess the safety and performance of robotically assisted ESD of superficial colorectal lesions, that otherwise cannot be optimally and radically removed by snare-based techniques
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, Single-Arm Study
| Arm | Type | Receives |
|---|---|---|
| Robotic ESD | Experimental | Device: EndoMASTER EASE Robotic system for ESDTreatment of early colorectal neoplasia / lateral spreading tumors by ESD using EndoMASTER EASE robotic system |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age ≥ 18 and ≤ 85;
- Suspected intramucosal neoplasm of the colon or rectum, including adenocarcinoma and tubular, tubulovillous, or villous adenomas.
Key exclusion criteria (8 listed)
- Informed consent not available;
- Carcinoma of colon or rectum with known involvement beyond the submucosa;
- Evidence of distant spread of colon cancer;
- Presence of another active malignancy;
- Pregnancy;
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 |
|---|---|---|
| EndoMASTER EASE Robotic system for ESDEndoMaster EASE System, is a robotic-assisted endoscopy system indicated for endoscopic visualization and therapeutic access to the adult gastrointestinal (GI) tract for endoscopic surgery | Device | Robotic ESD |
Primary outcome
Complete (R0) resection
Time frame: 30 days
rate of complete (R0) resection defined as en bloc, one-piece resection with histologically confirmed tumour-free lateral and vertical margins
15 secondary outcomes
Bleeding during or after the procedure
Time frame: 30 days
Perforation
Time frame: 30 days
Adjunctive procedures to control bleeding
Time frame: 1 day
All cause mortality
Time frame: 30 days
Infection
Time frame: 30 days
Impairment of renal function
Time frame: 30 days
Serious Adverse Events
Time frame: 30 days
Duration of procedure
Time frame: 1 day
Operator assessment of device performance
Time frame: 1 day
Device deficiencies
Time frame: 1 day
Length of Hospital stay
Time frame: 30 days
Histology of resected specimen
Time frame: 30 days
Colonoscopy followup
Time frame: 6 months, 18 months to 3 years
Cancer status by cross-sectional imaging (MRI / CT)
Time frame: 12 months and 3 years
Technical Success
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 7 Nov 2023.
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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.
Philip Chiu, MD study director
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EndoMASTER EASE Robotic system for ESD in people with Colonic Neoplasms, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 8 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 7 Nov 2023. 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 Hong Kong. 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.
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?
Complete (R0) resection (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 7 Nov 2023.