An interventional study of EndoMASTER EASE Robotic system for ESD in Colonic Neoplasms, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2023-11-07.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
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
1,433 studies on the registry are indexed under Colonic Neoplasms; 358 are open to participants now.
This study's enrollment of 45 is below the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment of early colorectal neoplasia / lateral spreading tumors by ESD using EndoMASTER EASE robotic system
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
Complete (R0) resection
rate of complete (R0) resection defined as en bloc, one-piece resection with histologically confirmed tumour-free lateral and vertical margins
Time frame: 30 days
Bleeding during or after the procedure
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
Time frame: 30 days
Perforation
Perforation at the ESD site as assessed by endoscopy
Time frame: 30 days
Adjunctive procedures to control bleeding
Use of coagrapser / clips
Time frame: 1 day
All cause mortality
Mortality
Time frame: 30 days
Infection
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
Time frame: 30 days
Impairment of renal function
renal failure as evidence of derangement of renal function with elevated creatinin level \> 100 mmol/l
Time frame: 30 days
Serious Adverse Events
Serous Adverse Events at preocedure and through discharge
Time frame: 30 days
Duration of procedure
OT time
Time frame: 1 day
Operator assessment of device performance
Operator assessment
Time frame: 1 day
Device deficiencies
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
Time frame: 1 day
Length of Hospital stay
Length of Hospital Stay
Time frame: 30 days
Histology of resected specimen
En bloc resection rate / R0 rate / positive vertical margin / positive lateral margin
Time frame: 30 days
Colonoscopy followup
Healing of operative site / presence of suspicious tissue for biopsy / presence of stricture
Time frame: 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
Time frame: 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
Time frame: 30 days
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong