Hutom Co., Ltd.

This sponsor-initiated, randomized controlled clinical trial aims to demonstrate the clinical efficacy of RUS NE Surgical Navigation System in patients undergoing robotic-assisted partial nephrectomy. The trial will compare the experimental group (n=102) using RUS NE with a control group (n=102), aiming to show an 10% reduction in operation time. The study will involve 6 medical centers in South Korea in patient recruitment and evaluate the clinical efficacy and feasibility of the software, which has been shown to be reliable in previous studies.
* Investigational Medical Device: RUS NE (Endoscopic Imaging Treatment Planning Software)
* Clinical Trial duration: 24 months from IRB approval -Target number of subjects: Total of 204 participants

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.