EndoMaster EASE System for Treatment of Colorectal Lesions
MASTERCESD
Prospective, Single Arm Study to Assess the Safety and Performance of the EndoMaster EASE System for the Treatment of Colorectal Lesions
1 other identifier
interventional
45
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2019
CompletedFirst Posted
Study publicly available on registry
December 12, 2019
CompletedStudy Start
First participant enrolled
May 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedNovember 7, 2023
November 1, 2023
2.7 years
December 10, 2019
November 4, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete (R0) resection
rate of complete (R0) resection defined as en bloc, one-piece resection with histologically confirmed tumour-free lateral and vertical margins
30 days
Secondary Outcomes (15)
Bleeding during or after the procedure
30 days
Perforation
30 days
Adjunctive procedures to control bleeding
1 day
All cause mortality
30 days
Infection
30 days
- +10 more secondary outcomes
Study Arms (1)
Robotic ESD
EXPERIMENTALTreatment of early colorectal neoplasia / lateral spreading tumors by ESD using EndoMASTER EASE robotic system
Interventions
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
Eligibility Criteria
You may qualify if:
- Age ≥ 18 and ≤ 85;
- Suspected intramucosal neoplasm of the colon or rectum, including adenocarcinoma and tubular, tubulovillous, or villous adenomas.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Combined Endoscopy Center, Prince of Wales Hospital
Hong Kong, 00000, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Philip Chiu, MD
Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 10, 2019
First Posted
December 12, 2019
Study Start
May 1, 2020
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
November 7, 2023
Record last verified: 2023-11