EndoMaster EASE System for Treatment of Colorectal Lesions

NCT ID: NCT04196062

Last Updated: 2023-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2022-12-31

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

Conditions

Colonic Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Robotic ESD

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

Group Type: EXPERIMENTAL

EndoMASTER EASE Robotic system for ESD

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Philip Wai Yan CHIU

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Chiu, MD

Role: STUDY_DIRECTOR

Chinese University of Hong Kong

Locations

Combined Endoscopy Center, Prince of Wales Hospital

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

CRE Ref. No. 2019.331

Identifier Type: -

Identifier Source: org_study_id