Clinical trial · Observational
Clinical Study to Prove Safety and Effectiveness When Applying RUS™ Surgical Navigation
Prospective Observational Clinical Study to Prove Safety and Effectiveness When Applying RUS™ Surgical Navigation, Endoscopic Imaging Treatment Planning Software, in Gastric Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RUS(TM) software : surgical navigation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- RUS (Surgical navigation, anatomy 3D-reconstruction)
- description
- single-arm study : prospective observational 1-arm (RUS group)
- interventionNames
- Device: RUS(TM) software : surgical navigation
Primary outcomes (9)
- measure
- CT turn around
- timeFrame
- 1 week
- description
- 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.
- measure
- Patient-specific pneumoperitoneum model accuracy
- timeFrame
- 1 month
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria:
* Among the subjects, the subjects are selected according to the following criteria:
1. Those who have been diagnosed with gastric cancer and are scheduled for robotic total gastrectomy;
2. A person who is 18 years of age or older and able to make independent judgment on their own;
3. A person who can have a CT scan according to the established protocol;
4. 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.
Exclusion Criteria:
* If any of the following exclusion criteria are met among the subjects, participants will be excluded from this clinical trial:
1. Vulnerable subjects (those who lack medical ability, or are illiterate, pregnant, newborns, minors (under 18), etc.);
2. 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.);
3. 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);
4. Persons with residual gastric cancer with a history of gastric surgery;
5. Persons who did not consent to this study or who withdrew consent.References
Publications (8)
- BACKGROUNDBano 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. PMID 23285539
- BACKGROUNDNimura 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. PMID 26697510
- BACKGROUNDNasajiyan 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. PMID 25225531
- BACKGROUNDDawda 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. PMID 31506884
- BACKGROUNDOktay 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. PMID 24579117
- BACKGROUNDMori 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. PMID 24505641
- RESULTKim 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.