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

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.

Study Overview

• Status: Completed
• Conditions: Colonic Neoplasms
• Intervention / Treatment: Device: EndoMASTER EASE Robotic system for ESD

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong, 00000
    • Combined Endoscopy Center, Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age ≥ 18 and ≤ 85;
2. Suspected intramucosal neoplasm of the colon or rectum, including adenocarcinoma and tubular, tubulovillous, or villous adenomas.

Exclusion Criteria:

1. Informed consent not available;
2. Carcinoma of colon or rectum with known involvement beyond the submucosa;
3. Evidence of distant spread of colon cancer;
4. Presence of another active malignancy;
5. Pregnancy;
6. Patients considered unfit for general anaesthesia;
7. The endoscopic platform cannot reach the target site;
8. Current participation in another clinical research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic ESD; Treatment of early colorectal neoplasia / lateral spreading tumors by ESD using EndoMASTER EASE robotic system	Device: EndoMASTER EASE Robotic system for ESD; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	30 days
Perforation	Perforation at the ESD site as assessed by endoscopy	30 days
Adjunctive procedures to control bleeding	Use of coagrapser / clips	1 day
All cause mortality	Mortality	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	30 days
Impairment of renal function	renal failure as evidence of derangement of renal function with elevated creatinin level > 100 mmol/l	30 days
Serious Adverse Events	Serous Adverse Events at preocedure and through discharge	30 days
Duration of procedure	OT time	1 day
Operator assessment of device performance	Operator assessment	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	1 day
Length of Hospital stay	Length of Hospital Stay	30 days
Histology of resected specimen	En bloc resection rate / R0 rate / positive vertical margin / positive lateral margin	30 days
Colonoscopy followup	Healing of operative site / presence of suspicious tissue for biopsy / presence of stricture	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	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	30 days

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Study Director: Philip Chiu, MD, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 10, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 4, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Colonic ESD; Robotic Endoscope
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Colonic Neoplasms
• Other Study ID Numbers: CRE Ref. No. 2019.331

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No