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.

Periampullary Cancer Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04095312
• Other study ID #: 1-2019-0030
• Status: Recruiting
• Phase: N/A
• Start date: September 17, 2019
• Est. completion date: April 2020

Study information

• Verified date: September 2019
• Source: Yonsei University
• Contact: Chang Moo Kang
• Phone: 82-2-2228-2135
• Email: CMKANG[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 33
• Est. completion date: April 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Periampullary Cancer

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Operative outcome	Operation time (minute)	immediate postoperation
Secondary	Operative outcome	Intraoperative bleeding volume (ml)	immediate postoperation
Secondary	Operative outcome	Length of stay (day)	1 month after operation
Secondary	Operative outcome	Complication rate (%)	1 month after operation