Combined Endoscopy Center, Prince of Wales Hospital
Hong Kong, 00000
Completed
NCT Number: NCT04196062
EndoMaster EASE System for 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.
Completed
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Conditions
Age range
18 year–85 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
EndoMASTER EASE Robotic system for ESD
DeviceEndoMaster 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 outcomes
-
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
Secondary outcomes
-
Bleeding during or after the procedure
Time frame: 30 days
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
Time frame: 30 days
Perforation at the ESD site as assessed by endoscopy
-
Adjunctive procedures to control bleeding
Time frame: 1 day
Use of coagrapser / clips
-
All cause mortality
Time frame: 30 days
Mortality
-
Infection
Time frame: 30 days
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
Time frame: 30 days
renal failure as evidence of derangement of renal function with elevated creatinin level > 100 mmol/l
-
Serious Adverse Events
Time frame: 30 days
Serous Adverse Events at preocedure and through discharge
-
Duration of procedure
Time frame: 1 day
OT time
-
Operator assessment of device performance
Time frame: 1 day
Operator assessment
-
Device deficiencies
Time frame: 1 day
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
Time frame: 30 days
Length of Hospital Stay
-
Histology of resected specimen
Time frame: 30 days
En bloc resection rate / R0 rate / positive vertical margin / positive lateral margin
-
Colonoscopy followup
Time frame: 6 months, 18 months to 3 years
Healing of operative site / presence of suspicious tissue for biopsy / presence of stricture
-
Cancer status by cross-sectional imaging (MRI / CT)
Time frame: 12 months and 3 years
local recurrence / recurrence at different site in colon / metastatic disease and location
-
Technical Success
Time frame: 30 days
en bloc, one-piece excision of the neoplasm irrespective of histopathology, in the absence of device-related SAE through 30 days
Sponsors and collaborators
Lead sponsor
Chinese University of Hong Kong
Other
Registry information
Official study title
Prospective, Single Arm Study to Assess the Safety and Performance of the EndoMaster EASE System for the Treatment of Colorectal Lesions
Acronym: MASTERCESD
Important dates
- Study start
- 2020
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Dec 12, 2019
- Registry last updated
- Nov 7, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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