Clinical Trial

A Multicenter Study of RUS NE

Recruiting
View on ClinicalTrials.gov →
Summary
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
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-03-05; most recent amendment 2025-09-10.
Status change: Not Yet Recruiting → Recruiting 2025-08-26
Trial Details
NCT Number NCT06868186
Lead Sponsor Hutom Corp
Collaborators: Asan Medical Center, Seoul National University Hospital, Samsung Medical Center, Chonnam National University Hospital, Kyungpook National University Hospital, Severance Hospital
Conditions Renal Tumors
Enrollment 204 participants
Start Date 2025-04-29
Primary Completion 2025-08-29 (estimated)
Study Completion 2026-04-30 (estimated)
Updated on ClinicalTrials.gov 2025-09-11