Back to resultsEndoMaster EASE System for Treatment of Colorectal Lesions (MASTERCESD)
Primary Purpose
Colonic Neoplasms
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
EndoMASTER EASE Robotic system for ESD
Sponsored by
About this trial
This is an interventional treatment trial for Colonic Neoplasms focused on measuring Colonic ESD, Robotic Endoscope
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 and ≤ 85;
- Suspected intramucosal neoplasm of the colon or rectum, including adenocarcinoma and tubular, tubulovillous, or villous adenomas.
Exclusion Criteria:
- 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.
Sites / Locations
- Combined Endoscopy Center, Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Robotic ESD
Arm Description
Treatment of early colorectal neoplasia / lateral spreading tumors by ESD using EndoMASTER EASE robotic system
Outcomes
Primary Outcome Measures
Complete (R0) resection
rate of complete (R0) resection defined as en bloc, one-piece resection with histologically confirmed tumour-free lateral and vertical margins
Secondary Outcome Measures
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
Perforation
Perforation at the ESD site as assessed by endoscopy
Adjunctive procedures to control bleeding
Use of coagrapser / clips
All cause mortality
Mortality
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
Impairment of renal function
renal failure as evidence of derangement of renal function with elevated creatinin level > 100 mmol/l
Serious Adverse Events
Serous Adverse Events at preocedure and through discharge
Duration of procedure
OT time
Operator assessment of device performance
Operator assessment
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
Length of Hospital stay
Length of Hospital Stay
Histology of resected specimen
En bloc resection rate / R0 rate / positive vertical margin / positive lateral margin
Colonoscopy followup
Healing of operative site / presence of suspicious tissue for biopsy / presence of stricture
Cancer status by cross-sectional imaging (MRI / CT)
local recurrence / recurrence at different site in colon / metastatic disease and location
Technical Success
en bloc, one-piece excision of the neoplasm irrespective of histopathology, in the absence of device-related SAE through 30 days
Full Information
NCT ID
NCT04196062
First Posted
December 10, 2019
Last Updated
May 1, 2022
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT04196062
Brief Title
EndoMaster EASE System for Treatment of Colorectal Lesions
Acronym
MASTERCESD
Official Title
Prospective, Single Arm Study to Assess the Safety and Performance of the EndoMaster EASE System for the Treatment of Colorectal Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colonic Neoplasms
Keywords
Colonic ESD, Robotic Endoscope
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, Single-Arm Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Robotic ESD
Arm Type
Experimental
Arm Description
Treatment of early colorectal neoplasia / lateral spreading tumors by ESD using EndoMASTER EASE robotic system
Intervention Type
Device
Intervention Name(s)
EndoMASTER EASE Robotic system for ESD
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete (R0) resection
Description
rate of complete (R0) resection defined as en bloc, one-piece resection with histologically confirmed tumour-free lateral and vertical margins
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Bleeding during or after the procedure
Description
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
Time Frame
30 days
Title
Perforation
Description
Perforation at the ESD site as assessed by endoscopy
Time Frame
30 days
Title
Adjunctive procedures to control bleeding
Description
Use of coagrapser / clips
Time Frame
1 day
Title
All cause mortality
Description
Mortality
Time Frame
30 days
Title
Infection
Description
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
Time Frame
30 days
Title
Impairment of renal function
Description
renal failure as evidence of derangement of renal function with elevated creatinin level > 100 mmol/l
Time Frame
30 days
Title
Serious Adverse Events
Description
Serous Adverse Events at preocedure and through discharge
Time Frame
30 days
Title
Duration of procedure
Description
OT time
Time Frame
1 day
Title
Operator assessment of device performance
Description
Operator assessment
Time Frame
1 day
Title
Device deficiencies
Description
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
Time Frame
1 day
Title
Length of Hospital stay
Description
Length of Hospital Stay
Time Frame
30 days
Title
Histology of resected specimen
Description
En bloc resection rate / R0 rate / positive vertical margin / positive lateral margin
Time Frame
30 days
Title
Colonoscopy followup
Description
Healing of operative site / presence of suspicious tissue for biopsy / presence of stricture
Time Frame
6 months, 18 months to 3 years
Title
Cancer status by cross-sectional imaging (MRI / CT)
Description
local recurrence / recurrence at different site in colon / metastatic disease and location
Time Frame
12 months and 3 years
Title
Technical Success
Description
en bloc, one-piece excision of the neoplasm irrespective of histopathology, in the absence of device-related SAE through 30 days
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 and ≤ 85;
Suspected intramucosal neoplasm of the colon or rectum, including adenocarcinoma and tubular, tubulovillous, or villous adenomas.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philip Wai Yan Chiu, MD, FRCSEd
Phone
+85235053952
Email
philipchiu@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Man Yee Yung
Phone
+85235052956
Email
myyung@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Chiu, MD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Study Director
Facility Information:
Facility Name
Combined Endoscopy Center, Prince of Wales Hospital
City
Hong Kong
ZIP/Postal Code
00000
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philip Chiu, MD
Phone
85226322627
Email
philipchiu@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Man Yee Yung
Phone
+85235052956
Email
myyung@surgery.cuhk.edu.hk
First Name & Middle Initial & Last Name & Degree
Philip WY Chiu, MD
12. IPD Sharing Statement
Learn more about this trial
EndoMaster EASE System for Treatment of Colorectal Lesions
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