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.

NCT04095312 | Unknown

• 1 other identifier: 1-2019-0030
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Periampullary Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Operative outcome

  immediate postoperation

• Operative outcome

  immediate postoperation

• Operative outcome

  1 month after operation

• Operative outcome

  1 month after operation

Study Arms (3)

pancreaticobiliary disease

EXPERIMENTAL

10 pancreaticobiliary disease cases

Procedure: Revo-i robotic surgery system (Model MSR-5100)

Urinary tract disease

EXPERIMENTAL

13 urinary tract disease cases

Procedure: Revo-i robotic surgery system (Model MSR-5100)

Colon disease

EXPERIMENTAL

10 colon disease cases

Procedure: Revo-i robotic surgery system (Model MSR-5100)

Interventions

Revo-i robotic surgery system (Model MSR-5100) PROCEDURE

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

Also known as: Revo-I robotic surgery, davinci, pancreas cancer

pancreaticobiliary disease

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Surgery, Yonsei University College of Medicine

Seoul, 03722, South Korea

RECRUITING

Related Publications (1)

• 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: 10.1016/S0022-5347(05)64548-X.

  PMID: 12187196 BACKGROUND

Central Study Contacts

Chang Moo Kang

CONTACT

82-2-2228-2135; CMKANG@yuhs.ac

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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"

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 19, 2019
• Study Start: September 17, 2019
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)