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SurgeryNCT05039333

Clinical Study to Prove Safety and Effectiveness When Applying RUS™ Surgical Navigation

An observational study of Surgery and Gastric Cancer, run by Hutom Corp 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 The sponsor has not verified this record for over two years, so it may be out of date.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

By uploading pre-operative patient information and patient CT data to RUS™, a virtual surgical environment with patient-specific relief prediction models can be provided. First, after uploading the CT and clinical information of a gastric cancer patient diagnosed with gastric cancer through an actual endoscopic biopsy… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Surgery, Gastric Cancer
What is being tested?
RUS(TM) software : surgical navigation
Type of treatment
Medical device
How many people
36 participants
Where
1 siteSouth Korea
Study dates
1 Sep 2021to 23 Jun 2022
Phase
Observational
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Diagnosed as gastric cancer Patients who will be carried out Robotic Gastrectomy in Yonsei University Health System, Severance Hospital

Who may be able to join

  • Among the subjects, the subjects are selected according to the following criteria:
  • Those who have been diagnosed with gastric cancer and are scheduled for robotic total gastrectomy;
  • A person who is 18 years of age or older and able to make independent judgment on their own;
  • A person who can have a CT scan according to the established protocol;
  • Before participating in the clinical trial, an interview was conducted in an independent space, the purpose and contents of the clinical trial were fully explained, and the consent to participate in this study was voluntarily given (approved by the institutional research ethics review committee) and those who signed.
  • For reference, internal employees and immediate family members can also participate in this study unless there is a special reason for exclusion.

Who cannot join

  • If any of the following exclusion criteria are met among the subjects, participants will be excluded from this clinical trial:
  • Vulnerable subjects (those who lack medical ability, or are illiterate, pregnant, newborns, minors (under 18), etc.);
  • Persons who cannot have a CT scan according to the prescribed protocol prior to gastric cancer surgery (contrast agent allergy, creatinine 1.5 times the normal maximum, claustrophobia, etc.);
  • Persons whose major artery/venous structure in the stomach or abdominal cavity has been altered due to previous surgery (due to gastric cancer or other abdominal surgery);
  • Persons with residual gastric cancer with a history of gastric surgery;
  • Persons who did not consent to this study or who withdrew consent.

Trial locations and contacts

1 site in 1 country.

Yu Min Kim, Professor contact

+82-2-2228-2100

ymkim@yuhs.ac

South Korea1 site

  • Yonsei University Health System Severance Hospital

    Seoul, 03722

    Yu Min Kim, Professor, 02-2228-2100, ymkim@yuhs.ac

Other trials in South Korea

About this study

Official title: Prospective Observational Clinical Study to Prove Safety and Effectiveness When Applying RUS™ Surgical Navigation, Endoscopic Imaging Treatment Planning Software, in Gastric Cancer Patients

By uploading pre-operative patient information and patient CT data to RUS™, a virtual surgical environment with patient-specific relief prediction models can be provided. First, after uploading the CT and clinical information of a gastric cancer patient diagnosed with gastric cancer through an actual endoscopic biopsy and scheduled for robotic total gastrectomy, RUS™ will operate normally to check whether patient-specific surgical navigation is available before or during surgery. In particular, when using the patient-specific surgery simulation system provided by RUS™, the CT information provides a patient-specific 3D environment well, so it will be checked regarding whether the surgeon can use it before or during surgery without any particular problems. Using RUS™ software, navigation information is used before or during surgery, and among these, parts that can be quantitatively compared with actual measurements will be evaluated as a secondary research goal. After the surgery, the investigators plan to check the amount of bleeding, duration of hospitalization, and the rate of complications by performing robot gastrointestinal resection using the navigation system to ensure that there are no problems with patient safety.

Read the detailed description
  • Obtain consent from a patient who is diagnosed with gastric cancer and is scheduled for robotic surgery.
  • Take an abdominal CT before gastric cancer surgery according to the prescribed protocol.
  • Upload patient information and CT information before surgery to RUS™, an endoscopic treatment image planning software, to build a 3D modeling navigation system for a patient-customized surgical environment. (Measure the time (in days) from the time the CT is uploaded to the time when the RUS™ software can be operated.)
  • Before surgery, use the RUS™ navigation system to check the patient's relief and anatomical structure, mark the planned trocar insertion site, and obtain distance information from the umbilical trocar. ⑤ After general anesthesia on the day of surgery, mark the Landmark 25 area on the abdominal wall using a surgical marking pen. In addition, the abdominal wall surface scan is performed using a laser 3D scanner. ⑥ After the undulations are formed, the deformed abdominal wall surface is scanned with a laser 3D scanner. ⑦ Evaluate the degree of agreement between the patient's actual relief state measured in steps ⑤ and ⑥ and the patient's relief model predicted through the relief prediction model in RUS™. ⑧ When the trocar is inserted through an anatomical landmark after the actual patient's relief, compare the position information of the trocar with the trocar position information of the RUS™ measured in advance in step ④ to check its accuracy. ⑨ Check whether the blood vessels that must be checked during the total gastrectomy procedure (left omentary artery, left umbilical vein, superior omentum, superior vena cava, left gastric artery, superior artery, and left hepatic branching left hepatic artery) are presented in the RUS™ blood vessel segmentation model. ⑩ Among the vessels mentioned in step ⑨, for the vessels suggested by RUS™ for vessels (left gastric artery, superior artery, left gastric vein, and gastric colonic vein), check the anatomical positional relationship and measure branch points during actual surgery. Check the accuracy of matching with the anatomical location information and branching distance of the segmentation model.
Being tested
RUS(TM) software : surgical navigation
Keywords
Surgical navigation, Robotic gastrectomy, Image-guided surgery, Anatomy 3D-reconstruction
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • RUS(TM) software : surgical navigationDevice

    This clinical trial is a sponsor-led clinical trial, and it is intended to confirm that RUS™, a surgical navigation system certified for level 2 endoscopic imaging treatment planning software, can be applied to real people as a clinical study by using preoperative CT and to confirm the safety of surgery. In addition, the secondary research objective was to examine the accuracy of the intra-abdominal surgical navigation system provided by RUS™ including: 1) the accuracy of the undulation prediction model, 2) the accuracy of the trocar insertion position, 3) the adequacy of 3D reconstruction of the main vessels, 4) the accuracy of the major vessel branching distances, 5) the intraoperative bleeding volume and operating time, and 6) the postoperative hospitalization period and complication rate were compared with the past control group.

Study groups in NCT05039333
Study groupRoleWhat they receive
RUS (Surgical navigation, anatomy 3D-reconstruction)single-arm study : prospective observational 1-arm (RUS group)
Receives: Device: RUS(TM) software : surgical navigation

What is being measured

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

  1. CT turn around

    After the subject's CT is uploaded to the RUS™ software and segmentation is started, it is evaluated whether the relief model is created, segmentation of organs and blood vessels, and 3D reconstruction are performed and uploaded within 3 days.

    Measured: 1 week

  2. Patient-specific pneumoperitoneum model accuracy

    The accuracy is evaluated by comparing the patient-specific relief prediction model presented by the RUS™ surgical navigation with the actual patient's relief model scan data.

    Measured: 1 month

  3. Pre-trocar insertion function accuracy

    When the virtual trocar is inserted into the relief model in RUS™, the position and distance information of the trocar is provided, and the accuracy is evaluated by comparing it with the insertion position of the real trocar.

    Measured: 1 week

  4. Major blood vessel presentation

    Evaluate whether the major blood vessels (a total of 7 (LGEA, RGEA, LGA, RGA, LGEV, RGEV, LGV)) that must be checked in total gastrectomy are 100% 3D reconstructed on the RUS™ navigation system.

    Measured: 1 week

  5. Distance of major blood vessels

    By comparing the branching distance of major blood vessels in RUS™ (total 7 (LGEA, RGEA, LGA, RGA, LGEV, RGEV, LGV)) and the branching distance of major blood vessels during actual surgery, it is evaluated whether the accuracy is greater than 90%.

    Measured: 1 week

  6. Bleeding volume

    When robotic total gastrectomy is performed using RUS™ surgical navigation, the amount of bleeding is measured and compared with the previous control group.

    Measured: 1 day

  7. Surgery time

    When robotic total gastric resection is performed using RUS™ surgical navigation, the operation time (console time in the case of robotic surgery) is measured and compared with the past control group.

    Measured: 1 day

  8. Hospital stay after surgery

    When robotic total gastrectomy is performed using RUS™ surgical navigation, the patient's postoperative hospital stay is checked and compared with the past control group.

    Measured: 1 month

  9. Complication rate

    When robotic total gastric resection is performed using RUS™ surgical navigation, the patient's complication rate is checked and compared with the past control group.

    Measured: 1 month

Timeline

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

  1. First posted9 Sep 2021
  2. Study start1 Sep 2021 (estimated)
  3. Primary completion24 Dec 2021 (estimated)
  4. Study completion23 Jun 2022 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05039333
Sponsor's protocol ID
1-2021-0036
Status last verified
Sep 2021
First submitted
26 Aug 2021
Last updated
9 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Bano J, Hostettler A, Nicolau SA, Cotin S, Doignon C, Wu HS, Huang MH, Soler L, Marescaux J. Simulation of pneumoperitoneum for laparoscopic surgery planning. Med Image Comput Comput Assist Interv. 2012;15(Pt 1):91-8. doi: 10.1007/978-3-642-33415-3_12.

    PubMed 23285539

  • Nimura Y, Di Qu J, Hayashi Y, Oda M, Kitasaka T, Hashizume M, Misawa K, Mori K. Pneumoperitoneum simulation based on mass-spring-damper models for laparoscopic surgical planning. J Med Imaging (Bellingham). 2015 Oct;2(4):044004. doi: 10.1117/1.JMI.2.4.044004. Epub 2015 Dec 17.

    PubMed 26697510

  • Nasajiyan N, Javaherfourosh F, Ghomeishi A, Akhondzadeh R, Pazyar F, Hamoonpou N. Comparison of low and standard pressure gas injection at abdominal cavity on postoperative nausea and vomiting in laparoscopic cholecystectomy. Pak J Med Sci. 2014 Sep;30(5):1083-7. doi: 10.12669/pjms.305.5010.

    PubMed 25225531

  • Dawda S, Camara M, Pratt P, Vale J, Darzi A, Mayer E. Patient-Specific Simulation of Pneumoperitoneum for Laparoscopic Surgical Planning. J Med Syst. 2019 Sep 10;43(10):317. doi: 10.1007/s10916-019-1441-z.

    PubMed 31506884

  • Oktay O, Zhang L, Mansi T, Mountney P, Mewes P, Nicolau S, Soler L, Chefd'hotel C. Biomechanically driven registration of pre- to intra-operative 3D images for laparoscopic surgery. Med Image Comput Comput Assist Interv. 2013;16(Pt 2):1-9. doi: 10.1007/978-3-642-40763-5_1.

    PubMed 24579117

  • Mori K, Sakuma I, Sato Y, Barillot C, Navab N. Preface. The 16th international conference on medical image computing and computer-assisted intervention-MICCAI 2013. Med Image Comput Comput Assist Interv. 2013;16(Pt 1):V-VIII. No abstract available.

    PubMed 24505641

  • Kim YM, Baek SE, Lim JS, Hyung WJ. Clinical application of image-enhanced minimally invasive robotic surgery for gastric cancer: a prospective observational study. J Gastrointest Surg. 2013 Feb;17(2):304-12. doi: 10.1007/s11605-012-2094-0. Epub 2012 Dec 1.

    PubMed 23207683

  • Park SH, Kim KY, Kim YM, Hyung WJ. Patient-specific virtual three-dimensional surgical navigation for gastric cancer surgery: A prospective study for preoperative planning and intraoperative guidance. Front Oncol. 2023 Feb 21;13:1140175. doi: 10.3389/fonc.2023.1140175. eCollection 2023.

    PubMed 36895483

Questions about this trial

What is this clinical trial studying?

An observational study of Surgery and Gastric Cancer, run by Hutom Corp 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 6 inclusion and 6 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 9 Sep 2021. 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 Yu Min Kim, Professor (+82-2-2228-2100, ymkim@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CT turn around (time frame: 1 week). The study lists 9 primary outcomes in all. 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 NCT05039333, which also lists 8 linked publications.

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 9 Sep 2021.

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