A Multicenter Study of RUS NE

A Multicenter, Randomized, Parallel-group Study to Evaluate Efficacy of Surgical Navigation System 'RUS NE' in Patient Underwent Robot-assisted Partial Nephrectomy

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

After selecting subjects and obtaining informed consent, randomization will be conducted. Robot-assisted partial nephrectomy will be performed using RUS NE or without using software. Parameters-associated with operation or clinical outcomes will be evaluated during hospitalization period or through outpatient follow-ups for up to 3 months after discharge.

Inclusion Criteria:

• Individuals who were diagnosed with renal tumor and undergo robot-assisted partial nephrectomy
• The diameter of renal tumor is 7cm or below
• Individuals aged between 19 and 80
• Individuals who, before participating in the clinical trial, undergo an interview in a separate place, understand sufficient explanation of the purpose and content of the trial, and voluntarily sign informed consent form

Exclusion Criteria:

• Individuals with solitary kidney or horseshoe kidney
• Individuals undergo bilateral nephrectomy
• Individuals undergo operation other than partial nephrecotmy
• Individuals with a history of abdominal surgery and are expected to have severe intra-abdominal adhesion influencing the surgical outcomes
• Individuals with severe chronic kidney disease (eGFR < 45, calculated with EPI-CKI equation)
• Individuals with American society of anesthesiologists physical status classification (ASA) IV-VI
• Individuals with a history of psychosis, alcohol abuse or are expected not to adhere to the schedule of the clinical study
• Individuals who were participated in other clinical study within 4 weeks of screening
• Individuals who are thought to be inappropriate to participate to the clinical trial by the investigators