EndoMaster EASE System for Treatment of Colorectal Lesions

Not Applicable

Completed

• Conditions: Colonic Neoplasms
• Interventions: Device: EndoMASTER EASE Robotic system for ESD

• Registration Number: NCT04196062
• Lead Sponsor: Chinese University of Hong Kong

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

Study Timeline

• Study First Submitted: 2019-12-10
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-12
• Study Start: 2020-05-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-04
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Robotic ESD	EndoMASTER EASE Robotic system for ESD	Treatment of early colorectal neoplasia / lateral spreading tumors by ESD using EndoMASTER EASE robotic system

Primary Outcome Measures

Name	Time	Method
Complete (R0) resection	30 days	rate of complete (R0) resection defined as en bloc, one-piece resection with histologically confirmed tumour-free lateral and vertical margins

Secondary Outcome Measures

Name	Time	Method
Duration of procedure	1 day	OT time
Length of Hospital stay	30 days	Length of Hospital Stay
Adjunctive procedures to control bleeding	1 day	Use of coagrapser / clips
Bleeding during or after the procedure	30 days	Bleeding as evidence by; 1. Active bleeding during the robotic ESD procedure; 2. 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	30 days	Perforation at the ESD site as assessed by endoscopy
All cause mortality	30 days	Mortality
Infection	30 days	Clinical sepsis with changes in inflammatory markers as evidence by; 1. clinical symptoms of fever, pulse \> 100; 2. radiological evidence of intraperitoneal collection; 3. elevated WBC count of \> 10.0
Impairment of renal function	30 days	renal failure as evidence of derangement of renal function with elevated creatinin level \> 100 mmol/l
Serious Adverse Events	30 days	Serous Adverse Events at preocedure and through discharge
Operator assessment of device performance	1 day	Operator assessment
Device deficiencies	1 day	Device malfunction and Use errors during the ESD procedure as evidence by; 1. cessation of the function of the EndoMASTER EASE system; 2. need to use of the immediate cessation button for the EndoMASTER EASE system
Colonoscopy followup	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)	12 months and 3 years	local recurrence / recurrence at different site in colon / metastatic disease and location
Technical Success	30 days	en bloc, one-piece excision of the neoplasm irrespective of histopathology, in the absence of device-related SAE through 30 days
Histology of resected specimen	30 days	En bloc resection rate / R0 rate / positive vertical margin / positive lateral margin

Trial Locations

Locations (1)

Combined Endoscopy Center, Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong