A Multicenter Study of RUS NE

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2025
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
Epistemonikos ID: 7d60bc2b7191eb301c0538be0b644603d8e2cf51
First added on: Mar 27, 2025