NCT06945640

Evaluation of 'RUS NE' in Robot-Assisted Partial Nephrectomy: Efficacy, Safety, and Stability

Evaluation of the Efficacy, Safety, and Stability of the Surgical Navigation System 'RUS NE' in Robot-Assisted Partial Nephrectomy: A Retrospective and Prospective Comparative Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Hutom Corp · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study is a retrospective and prospective comparative study evaluating the efficacy, safety, and stability of the surgical navigation system 'RUS NE' in robot-assisted partial nephrectomy. The study aims to compare intraoperative and postoperative clinical indicators between the experimental group and the control group to verify the clinical effectiveness and stability of RUS NE. This research is conducted as part of the 2025 Corporate Verification Support Project of the Global Innovative Medical Technology Verification Support Center at Asan Medical Center (ARIS Project Number: A20250116) and is supported by the Korea Health Industry Development Institute's healthcare technology research and development program.

Detailed description

1\. Study Objectives 1. Efficacy Evaluation: Comparison of resection volume, operative time, and blood loss between the experimental group (RUS NE-assisted) and the control group (standard procedure). o Analysis of whether RUS NE facilitates accurate tumor localization to minimize resection margins. 2. Stability Evaluation: Validation of CT turn-around time, accuracy of 3D image reconstruction, and system functionality. \- Assessment of the device's reliability and stability in a real surgical environment. 3. Study Methods * Study Design: Retrospective and prospective, single-center, comparative study. * Study Population: Patients scheduled for robot-assisted partial nephrectomy. * Study Period: From IRB approval to December 31, 2025. * Sample Size: 80 patients (20 in the experimental group, 60 in the control group). * Control group selection: Propensity Score Matching (1:3) applied to match previously treated patients. 4. Study Endpoints Primary Endpoint: Resection volume: To assess renal function preservation. Secondary Endpoints: Operative time, stage-specific time, blood loss, hospital stay, and postoperative complications. Stability Evaluation: CT turn-around time, accuracy of 3D modeling, and adequacy of vascular and tumor reconstruction.

Conditions

• Kidney Neoplasm
• Nephrectomy
• Surgical Navigation Systems
• Renal Mass
• Robot-assisted Urological Surgery

Interventions

Type	Name	Description
DEVICE	RUS NE	RUS NE is a surgical navigation system designed for use in robot-assisted partial nephrectomy. It reconstructs CT images into 3D models, providing visualization of tumor and vascular structures to enhance surgical precision and optimize resection planning. This system aids in reducing resection volume and improving operative outcomes by integrating anatomical insights into the surgical workflow.

Timeline

• Start date: 2025-04-30
• Primary completion: 2025-06-10
• Completion: 2026-02-01
• First posted: 2025-04-25
• Last updated: 2025-09-16

Locations

1 site across 1 country: South Korea