EndoMaster EASE System for Treatment of Colorectal Lesions

Colonic Neoplasms Clinical Trial

— MASTERCESD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196062
• Other study ID #: CRE Ref. No. 2019.331
• Status: Completed
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Device:
• 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

Locations

Country	Name	City	State
Hong Kong	Combined Endoscopy Center, Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Perforation	Perforation at the ESD site as assessed by endoscopy	30 days
Secondary	Adjunctive procedures to control bleeding	Use of coagrapser / clips	1 day
Secondary	All cause mortality	Mortality	30 days
Secondary	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
Secondary	Impairment of renal function	renal failure as evidence of derangement of renal function with elevated creatinin level > 100 mmol/l	30 days
Secondary	Serious Adverse Events	Serous Adverse Events at preocedure and through discharge	30 days
Secondary	Duration of procedure	OT time	1 day
Secondary	Operator assessment of device performance	Operator assessment	1 day
Secondary	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
Secondary	Length of Hospital stay	Length of Hospital Stay	30 days
Secondary	Histology of resected specimen	En bloc resection rate / R0 rate / positive vertical margin / positive lateral margin	30 days
Secondary	Colonoscopy followup	Healing of operative site / presence of suspicious tissue for biopsy / presence of stricture	6 months, 18 months to 3 years
Secondary	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
Secondary	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