Clinical Study for Evaluating the Clinical Safety and Effectiveness of the Automated Robotic Robot, Revo-i Surgical Robot System (Model MSR-5100), Used for General Endoscopic Surgery.

Study Overview
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Brief Summary
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This study is based on the ergonomic features of the most common surgical procedures, which require advanced techniques and relatively difficult operations, such as pancreatobiliary surgery, prostatectomy, nephrectomy, colon and rectal resection. This study id designed to verify the clinical safety and effectiveness of 'Revo-i Surgical Robot System (Model MSR-5100), developed by Mirae Company to overcome the limitations of general laparoscopic surgery.

Official Title
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A Prospective, Single-center, Single-group Clinical Study for Evaluating the Clinical Safety and Effectiveness of the Automated Robotic Robot, Revo-i Surgical Robot System (Model MSR-5100), Used for General Endoscopic Surgery.

Conditions
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Periampullary Cancer

Intervention / Treatment
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* Procedure: Revo-i robotic surgery system (Model MSR-5100)
* Procedure: Revo-i robotic surgery system (Model MSR-5100)
* Procedure: Revo-i robotic surgery system (Model MSR-5100)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All of the following selection criteria must be met to be enrolled in this clinical trial. Common Standard Adults over 19 Voluntary consent to clinical research and willingness to comply with the protocol Pancreaticobiliary tract area surgery A person deemed to need surgery for pancreaticobiliary tract due to one or more of the following reasons: Benign and borderline periampullary cancer Resectable masses (biliary cancer, pancreatic cancer, duodenal cancer, AoV cancer, etc.) Congenital gallbladder cysts Endoscopic treatment of adenocarcinoma and early stage lesions of ampulla There is no major organ or vascular invasion Lack of severe pancreatitis and cholangitis Patients considering laparoscopic surgery who cannot perform da Vinci robot surgery due to personal expense Others who have been diagnosed with high latitude pancreaticobiliary tract surgery according to the researcher's judgment Prostatectomy Persons deemed necessary for prostatectomy in the following cases: -The prostate is at low risk or medium risk, and the tumor is located at the local site without metastasis Criteria for Prostate Risk Group Prostate low risk group Prostate Cancer Stage (T1-T2a) and Gleason Grade ≤6 and PSA <10ng / ml Risk group in the prostate Prostate cancer stage (T2b-T2c) or Gleason grade 7 or10 ng / ml ≤ PSA ≤ 20 ng / ml * Reference) NCCN (National Comprehensive Cancer Network), 2015 Others who have been diagnosed as requiring prostate surgery according to the researcher's judgment Nephrectomy Persons deemed necessary for renal resection should: Localized renal cell carcinoma without metastasis to organs other than the kidney Stage 1A, IB, II, III * Reference) NCCN (National Comprehensive Cancer Network), 2011 Others who have been diagnosed with nephrectomy according to the researcher's judgment Colon and Rectal Surgery A person who needs to have a resection for colon and rectal cancer Histopathologically confirmed by adenocarcinoma of the rectum or colon No remote transition (M0) Primary tumor without other peripheral organ involvement (T1-T4a) When intestinal obstruction is not accompanied In case of elective surgery Does not require resection of any organ other than the primary tumor Others who have been diagnosed as having to need colon and rectal resection according to the researcher's judgment Exclusion Criteria: Common Standard If you have mental illness or serious systemic disease Body Mass Index (BMI) ≥ 30, high obesity General anesthesia is not possible due to uncontrolled bleeding tendency or lowering of cardiopulmonary function If you have a positive or reactive pregnancy Patients who wish to undergo conventional laparoscopy or da Vinci robotic surgery Pancreaticobiliary tract area surgery -If you have a history of open abdominal surgery Liver cirrhosis Patients with abnormally inoperable pancreatobiliary malformations, other pancreatic biliary diseases, or systemic diseases Prostatectomy Surgical removal of prostate tumor is difficult or life expectancy is short Meets the exclusion criteria of prostatectomy below <Exclusion Criteria for Prostatectomy> Clinical study subjects at high risk group Criteria of Prostate Risk Group Prostate High Risk Group Prostate Cancer Stage (T3a and above) or Gleason class ≥ 8 or ≤ 10 or PSA> 20ng / ml * Reference) NCCN (National Comprehensive Cancer Network), 2015 Have a history of surgery on the prostate, urethra, or bladder neck If you have a history of open surgery Nephrectomy If you have a history of epigastric open surgery or have had kidney surgery History of chronic inflammation in the kidneys and the posterior cavity 2) prone to bleeding 3) When a disease such as kidney or vascular malformation is impossible to the extent that surgery is impossible Colon and Rectal Surgery If you have a history of lower abdominal and pelvic laparotomy prone to bleeding If you are older than 80 years old In case of remote transition (M1) When long-term complications other than adjacent organ invasion (T4b) or primary tumor are needed Accompanied by intestinal obstruction, perforation, or emergency surgery

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In a study involving relatively small groups of 10 to 50 people, the study showed a high success rate of more than 90% similar to the study of more than 100 large groups, and the stability was well proven. total 33 patients (10 pancreaticobiliary tracts, 13 urinary tract areas, 10 colonic areas), the minimum number of clinical studies that can be statistically analyzed within the limits to meet the study objective of evaluating the accuracy of procedure
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pancreaticobiliary disease<br>10 pancreaticobiliary disease cases | Procedure: Revo-i robotic surgery system (Model MSR-5100)<br>* for evaluating the clinical safety and effectiveness of the automated robotic robot, Revo-i Surgical Robot System (Model MSR-5100), used for general HBP surgery<br>* Other names: Revo-I robotic surgery, davinci, pancreas cancer;|
| Experimental: Urinary tract disease<br>13 urinary tract disease cases | Procedure: Revo-i robotic surgery system (Model MSR-5100)<br>* for evaluating the clinical safety and effectiveness of the automated robotic robot, Revo-i Surgical Robot System (Model MSR-5100), used for general Uro surgery<br>* Other names: Revo-I robotic surgery, davinci, Urology;|
| Experimental: Colon disease<br>10 colon disease cases | Procedure: Revo-i robotic surgery system (Model MSR-5100)<br>* for evaluating the clinical safety and effectiveness of the automated robotic robot, Revo-i Surgical Robot System (Model MSR-5100), used for general colorectal surgery<br>* Other names: Revo-I robotic surgery, davinci, colorectal cancer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation success rate | Surgery is complete without significant complications up to 24 hours after surgery and without conversion to other operations (laparotomy or laparoscopy) | 24hours after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operative outcome | Operation time (minute) | immediate postoperation | 
| Operative outcome | Intraoperative bleeding volume (ml) | immediate postoperation | 
| Operative outcome | Length of stay (day) | 1 month after operation | 
| Operative outcome | Complication rate (%) | 1 month after operation |