EndoMaster EASE System for Treatment of Colorectal Lesions

Study Overview
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Brief Summary
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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
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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

Official Title
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Prospective, Single Arm Study to Assess the Safety and Performance of the EndoMaster EASE System for the Treatment of Colorectal Lesions

Conditions
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Colonic Neoplasms

Intervention / Treatment
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* Device: EndoMASTER EASE Robotic system for ESD


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, Single-Arm Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Robotic ESD<br>Treatment of early colorectal neoplasia / lateral spreading tumors by ESD using EndoMASTER EASE robotic system | Device: EndoMASTER EASE Robotic system for ESD<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonic ESD, Robotic Endoscope