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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06945640
• Lead Sponsor: Hutom Corp

Brief 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.

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-18
• Last Update Submitted: 2025-04-18
• Study First Posted: 2025-04-25
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-05
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Resection volume	At the time of surgery	Resection volume were measured by ellipsoid formula. The maximum longitudinal length of the resected kidney specimen is measured along the X-axis, with perpendicular measurements taken along the Y and Z axes. The volume is estimated using the formula: (π/6) × X × Y × Z.

Secondary Outcome Measures

Name	Time	Method
Operative time	At the time of surgery	The total amount time for robot-assisted partial nephrectomy, including the time for surgical console manipulation

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of