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Periampullary CancerNCT04095312

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 study testing Revo-i robotic surgery system (Model MSR-5100) in people with Periampullary Cancer, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Periampullary Cancer
What is being tested?
Revo-i robotic surgery system (Model MSR-5100)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteSouth Korea
Study dates
17 Sep 2019to Apr 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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:
  • -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
  • Others who have been diagnosed as requiring prostate surgery according to the researcher's judgment
  • Nephrectomy
  • 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
  • Others who have been diagnosed with nephrectomy according to the researcher's judgment
  • Colon and Rectal Surgery
  • 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
  • Others who have been diagnosed as having to need colon and rectal resection according to the researcher's judgment

Who cannot join

  • 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
Show all 26Show fewer
  • 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
  • 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
  • If you have a history of epigastric open surgery or have had kidney surgery
  • 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
  • If you have a history of lower abdominal and pelvic laparotomy
  • prone to bleeding
  • If you are older than 80 years old
  • In case of remote transition (M1)
  • When long-term complications other than adjacent organ invasion (T4b) or primary tumor are needed
  • Accompanied by intestinal obstruction, perforation, or emergency surgery

Trial locations and contacts

1 site in 1 country.

Chang Moo Kang contact

82-2-2228-2135

CMKANG@yuhs.ac

South Korea1 site, 1 recruiting

  • Department of Surgery, Yonsei University College of Medicine

    Seoul, 03722

    Chang Moo Kang, MD, 82-2-2228-2135, cmkang@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

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.

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.

Being tested
Revo-i robotic surgery system (Model MSR-5100)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Revo-I robotic surgery, davinci, pancreas cancer

    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)Procedure or surgery

    Also called Revo-I robotic surgery, davinci, Urology

    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)Procedure or surgery

    Also called Revo-I robotic surgery, davinci, colorectal cancer

    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

Study groups in NCT04095312
Study groupRoleWhat they receive
pancreaticobiliary diseaseExperimental10 pancreaticobiliary disease cases
Receives: Procedure: Revo-i robotic surgery system (Model MSR-5100)
Urinary tract diseaseExperimental13 urinary tract disease cases
Receives: Procedure: Revo-i robotic surgery system (Model MSR-5100)
Colon diseaseExperimental10 colon disease cases
Receives: Procedure: Revo-i robotic surgery system (Model MSR-5100)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 24hours after operation

Secondary outcomes (4)

  1. Operative outcome

    Operation time (minute)

    Measured: immediate postoperation

  2. Operative outcome

    Intraoperative bleeding volume (ml)

    Measured: immediate postoperation

  3. Operative outcome

    Length of stay (day)

    Measured: 1 month after operation

  4. Operative outcome

    Complication rate (%)

    Measured: 1 month after operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2019
  2. Study start17 Sep 2019
  3. Primary completionMar 2020 (estimated)
  4. Study completionApr 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04095312
Sponsor's protocol ID
1-2019-0030
Status last verified
Sep 2019
First submitted
17 Sep 2019
Last updated
30 Sep 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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: 10.1016/S0022-5347(05)64548-X.

    PubMed 12187196

Questions about this trial

What is this clinical trial studying?

A study testing Revo-i robotic surgery system (Model MSR-5100) in people with Periampullary Cancer, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Chang Moo Kang (82-2-2228-2135, CMKANG@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Operation success rate (time frame: 24hours after operation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04095312, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.

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