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.

Last updated: September 26, 2019
Sponsor: Yonsei University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04095312
1-2019-0030
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 theprotocol

  • Pancreaticobiliary tract area surgery
  1. A person deemed to need surgery for pancreaticobiliary tract due to one or moreof the following reasons:
  • Benign and borderline periampullary cancer

  • Resectable masses (biliary cancer, pancreatic cancer, duodenal cancer, AoVcancer, 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

  1. Patients considering laparoscopic surgery who cannot perform da Vinci robotsurgery due to personal expense

  2. Others who have been diagnosed with high latitude pancreaticobiliary tractsurgery 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 thelocal site without metastasis Criteria for Prostate Risk Group Prostate low riskgroup Prostate Cancer Stage (T1-T2a) and Gleason Grade ≤6 and PSA <10ng / ml Riskgroup 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
  1. Others who have been diagnosed as requiring prostate surgery according to theresearcher's judgment
  • Nephrectomy
  1. Persons deemed necessary for renal resection should: Localized renal cell carcinoma without metastasis to organs other than the kidneyStage 1A, IB, II, III
  • Reference) NCCN (National Comprehensive Cancer Network), 2011
  1. Others who have been diagnosed with nephrectomy according to the researcher'sjudgment
  • 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

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

Exclusion

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 orlowering 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 withabnormally inoperable pancreatobiliary malformations, other pancreatic biliarydiseases, 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 forProstatectomy>

  • Clinical study subjects at high risk group Criteria of Prostate Risk GroupProstate High Risk Group Prostate Cancer Stage (T3a and above) or Gleasonclass ≥ 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

  1. prone to bleeding 3) When a disease such as kidney or vascular malformation isimpossible 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 primarytumor are needed

  6. Accompanied by intestinal obstruction, perforation, or emergency surgery

Study Design

Total Participants: 33
Study Start date:
September 17, 2019
Estimated Completion Date:
April 30, 2020

Connect with a study center

  • Department of Surgery, Yonsei University College of Medicine

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

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