EndoMaster EASE System for Treatment of Colorectal Lesions (MASTERCESD)

The Chinese University of Hong Kong

Status: Completed

Conditions: Colonic Neoplasms

Treatments: Device: EndoMASTER EASE Robotic system for ESD

Study type: Interventional

Funder types: Other

Identifiers

NCT04196062

CRE Ref. No. 2019.331

Details and patient eligibility

About

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.

Full 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

Enrollment: 45 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Robotic ESD

Experimental group

Description:

Treatment of early colorectal neoplasia / lateral spreading tumors by ESD using EndoMASTER EASE robotic system

Treatment:

Device: EndoMASTER EASE Robotic system for ESD