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.

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.

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.

Study Overview

• Status: Unknown
• Conditions: Periampullary Cancer
• Intervention / Treatment: 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)

• Study Type: Interventional
• Enrollment (Anticipated): 33
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chang Moo Kang; Phone Number: 82-2-2228-2135; Email: CMKANG@yuhs.ac

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Department of Surgery, Yonsei University College of Medicine
    • Contact: Chang Moo Kang, MD; Phone Number: 82-2-2228-2135; Email: cmkang@yuhs.ac

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

All of the following selection criteria must be met to be enrolled in this clinical trial.

• Common Standard

  1. Adults over 19
  2. Voluntary consent to clinical research and willingness to comply with the protocol

• Pancreaticobiliary tract area surgery

  1. 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
  2. Patients considering laparoscopic surgery who cannot perform da Vinci robot surgery due to personal expense
  3. Others who have been diagnosed with high latitude pancreaticobiliary tract surgery according to the researcher's judgment

• Prostatectomy

  1. 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

  2. Others who have been diagnosed as requiring prostate surgery according to the researcher's judgment

• Nephrectomy

  1. 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

  2. Others who have been diagnosed with nephrectomy according to the researcher's judgment

• Colon and Rectal Surgery

  1. 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
  2. Others who have been diagnosed as having to need colon and rectal resection according to the researcher's judgment

Exclusion Criteria:

• Common Standard

  1. If you have mental illness or serious systemic disease
  2. Body Mass Index (BMI) ≥ 30, high obesity
  3. General anesthesia is not possible due to uncontrolled bleeding tendency or lowering of cardiopulmonary function
  4. If you have a positive or reactive pregnancy
  5. 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

  1. Surgical removal of prostate tumor is difficult or life expectancy is short

  2. 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

  1. If you have a history of epigastric open surgery or have had kidney surgery
  2. 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

  1. If you have a history of lower abdominal and pelvic laparotomy
  2. prone to bleeding
  3. If you are older than 80 years old
  4. In case of remote transition (M1)
  5. When long-term complications other than adjacent organ invasion (T4b) or primary tumor are needed
  6. Accompanied by intestinal obstruction, perforation, or emergency surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: pancreaticobiliary disease; 10 pancreaticobiliary disease cases	Procedure: Revo-i robotic surgery system (Model MSR-5100); 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; Other Names: Revo-I robotic surgery, davinci, pancreas cancer; Procedure: Revo-i robotic surgery system (Model MSR-5100); 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; Other Names: Revo-I robotic surgery, davinci, Urology; Procedure: Revo-i robotic surgery system (Model MSR-5100); 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; Other Names: Revo-I robotic surgery, davinci, colorectal cancer
Experimental: Urinary tract disease; 13 urinary tract disease cases	Procedure: Revo-i robotic surgery system (Model MSR-5100); 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; Other Names: Revo-I robotic surgery, davinci, pancreas cancer; Procedure: Revo-i robotic surgery system (Model MSR-5100); 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; Other Names: Revo-I robotic surgery, davinci, Urology; Procedure: Revo-i robotic surgery system (Model MSR-5100); 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; Other Names: Revo-I robotic surgery, davinci, colorectal cancer
Experimental: Colon disease; 10 colon disease cases	Procedure: Revo-i robotic surgery system (Model MSR-5100); 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; Other Names: Revo-I robotic surgery, davinci, pancreas cancer; Procedure: Revo-i robotic surgery system (Model MSR-5100); 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; Other Names: Revo-I robotic surgery, davinci, Urology; Procedure: Revo-i robotic surgery system (Model MSR-5100); 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; Other Names: Revo-I robotic surgery, davinci, colorectal cancer

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Yonsei University

Publications and helpful links

General Publications

• Menon M, Shrivastava A, Tewari A, Sarle R, Hemal A, Peabody JO, Vallancien G. Laparoscopic and robot assisted radical prostatectomy: establishment of a structured program and preliminary analysis of outcomes. J Urol. 2002 Sep;168(3):945-9. doi: 10.1097/01.ju.0000023660.10494.7d.

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 17, 2019
• First Posted (Actual): September 19, 2019

Study Record Updates

• Last Update Posted (Actual): September 30, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Pancrelipase
• Other Study ID Numbers: 1-2019-0030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No