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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04095312
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Periampullary Cancer Procedure: Revo-i robotic surgery system (Model MSR-5100) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 33 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : April 2020

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 Name: Revo-I robotic surgery, davinci, pancreas 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 Uro surgery
Other Name: Revo-I robotic surgery, davinci, Urology

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 colorectal surgery
Other Name: Revo-I robotic surgery, davinci, colorectal cancer




Primary Outcome Measures :
  1. Operation success rate [ Time Frame: 24hours after operation ]
    Surgery is complete without significant complications up to 24 hours after surgery and without conversion to other operations (laparotomy or laparoscopy)


Secondary Outcome Measures :
  1. Operative outcome [ Time Frame: immediate postoperation ]
    Operation time (minute)

  2. Operative outcome [ Time Frame: immediate postoperation ]
    Intraoperative bleeding volume (ml)

  3. Operative outcome [ Time Frame: 1 month after operation ]
    Length of stay (day)

  4. Operative outcome [ Time Frame: 1 month after operation ]
    Complication rate (%)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04095312


Contacts
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Contact: Chang Moo Kang 82-2-2228-2135 CMKANG@yuhs.ac

Locations
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Korea, Republic of
Department of Surgery, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Chang Moo Kang, MD    82-2-2228-2135    cmkang@yuhs.ac   
Sponsors and Collaborators
Yonsei University

Publications:
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT04095312    
Other Study ID Numbers: 1-2019-0030
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No