Colonic Neoplasms
Conditions
Keywords
Colonic ESD, Robotic Endoscope
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
Interventions
DEVICEEndoMASTER 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
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, Single-Arm Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete (R0) resection | 30 days | rate of complete (R0) resection defined as en bloc, one-piece resection with histologically confirmed tumour-free lateral and vertical margins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection | 30 days | 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 |
| Bleeding during or after the procedure | 30 days | 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 |
| Perforation | 30 days | Perforation at the ESD site as assessed by endoscopy |
| Adjunctive procedures to control bleeding | 1 day | Use of coagrapser / clips |
| All cause mortality | 30 days | Mortality |
| Impairment of renal function | 30 days | renal failure as evidence of derangement of renal function with elevated creatinin level \> 100 mmol/l |
| Serious Adverse Events | 30 days | Serous Adverse Events at preocedure and through discharge |
| Duration of procedure | 1 day | OT time |
| Operator assessment of device performance | 1 day | Operator assessment |
| Device deficiencies | 1 day | Device malfunction and Use errors during the ESD procedure as evidence by 1. cessation of the function of the EndoMASTER EASE system 2. need to use of the immediate cessation button for the EndoMASTER EASE system |
| Length of Hospital stay | 30 days | Length of Hospital Stay |
| Histology of resected specimen | 30 days | En bloc resection rate / R0 rate / positive vertical margin / positive lateral margin |
| Colonoscopy followup | 6 months, 18 months to 3 years | Healing of operative site / presence of suspicious tissue for biopsy / presence of stricture |
| Cancer status by cross-sectional imaging (MRI / CT) | 12 months and 3 years | local recurrence / recurrence at different site in colon / metastatic disease and location |
| Technical Success | 30 days | en bloc, one-piece excision of the neoplasm irrespective of histopathology, in the absence of device-related SAE through 30 days |
Countries
Hong Kong
Outcome results
None listed