Evaluating the RUS NE Surgical Navigation System During Robot-Assisted Partial Nephrectomy for Renal Tumors A Multicenter Randomized Study in Adults Aged 19 to 80 Years

What this Trial Is About

Researchers are evaluating the clinical effectiveness of the RUS NE Surgical Navigation System in patients undergoing robot-assisted partial nephrectomy for renal tumors. This randomized controlled trial aims to compare the operation time between patients using the RUS NE software and those who do not, with a goal to demonstrate a 10% reduction in surgery duration. The study involves 204 participants recruited from six medical centers in South Korea and focuses on assessing the feasibility and reliability of this imaging treatment planning software. Participants will be randomly assigned to one of two groups one group will have robot-assisted partial nephrectomy using the RUS NE software, which creates a 3D model of the tumor and surrounding organs based on CT images to assist surgical planning the other group will undergo the surgery without this software. The procedures will be performed following informed consent and randomization, and participants will be monitored during hospitalization and through outpatient follow-ups. During the study, researchers will collect data on operative time, tumor and vessel identification time, resection volume, and postoperative complications over a period of up to 16 weeks after surgery. Participants will undergo assessments during their hospital stay and outpatient visits for up to three months post-discharge, allowing evaluation of the softwares clinical impact and safety. The total study duration is 24 months starting from institutional review board approval.

A Multicenter Study of RUS NE