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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Robotic ESD | Experimental | Treatment of early colorectal neoplasia / lateral spreading tumors by ESD using EndoMASTER EASE robotic system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoMASTER EASE Robotic system for ESD | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding during or after the procedure | Bleeding as evidence by
| 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip Chiu, MD | Chinese University of Hong Kong | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Combined Endoscopy Center, Prince of Wales Hospital | Hong Kong | 00000 | Hong Kong |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Prospective, Single-Arm Study
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| Perforation |
Perforation at the ESD site as assessed by endoscopy |
| 30 days |
| Adjunctive procedures to control bleeding | Use of coagrapser / clips | 1 day |
| All cause mortality | Mortality | 30 days |
| Infection | Clinical sepsis with changes in inflammatory markers as evidence by
| 30 days |
| Impairment of renal function | renal failure as evidence of derangement of renal function with elevated creatinin level > 100 mmol/l | 30 days |
| Serious Adverse Events | Serous Adverse Events at preocedure and through discharge | 30 days |
| Duration of procedure | OT time | 1 day |
| Operator assessment of device performance | Operator assessment | 1 day |
| Device deficiencies | Device malfunction and Use errors during the ESD procedure as evidence by
| 1 day |
| Length of Hospital stay | Length of Hospital Stay | 30 days |
| Histology of resected specimen | En bloc resection rate / R0 rate / positive vertical margin / positive lateral margin | 30 days |
| Colonoscopy followup | Healing of operative site / presence of suspicious tissue for biopsy / presence of stricture | 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 | 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 | 30 days |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |