EndoMaster EASE System for Treatment of Colorectal Lesions

N/ACompletedNCT04196062

Chinese University of Hong Kong45 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colonic Neoplasms

Interventions

EndoMASTER EASE Robotic system for ESDDEVICE

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

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Combined Endoscopy Center, Prince of Wales Hospital

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Complete (R0) resection

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 Outcomes

Bleeding during or after the procedure

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

Time frame: 30 days

Perforation

Perforation at the ESD site as assessed by endoscopy

Time frame: 30 days

Adjunctive procedures to control bleeding

Use of coagrapser / clips

Time frame: 1 day

All cause mortality

Mortality

Time frame: 30 days

Infection

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

Time frame: 30 days

Impairment of renal function

renal failure as evidence of derangement of renal function with elevated creatinin level \> 100 mmol/l

Time frame: 30 days

Serious Adverse Events

Serous Adverse Events at preocedure and through discharge

Data from ClinicalTrials.gov

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