Evaluation of 'RUS NE' in Robot-Assisted Partial Nephrectomy: Efficacy, Safety, and Stability (HTK_002)

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Nephrectomy; Renal Mass; Robot-assisted Urological Surgery; Kidney Neoplasm; Surgical Navigation Systems
• Intervention / Treatment: Device: RUS NE

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• South Korea
  • Seoul, South Korea
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

[Experimental Group]

1. Patients diagnosed with renal cancer scheduled for robot-assisted partial nephrectomy using the RUS system, aged between 20 and 80 years.
2. Patients who voluntarily consent to participate in this clinical trial and sign the written informed consent form.
3. Patients with a renal tumor measuring ≤10 cm in maximum diameter on preoperative CT imaging.
4. Patients with a RENAL Nephrometry Score between 4 and 12.

[Control Group]

1. Patients diagnosed with renal cancer who underwent robot-assisted partial nephrectomy using the standard surgical method at the institution between January 1, 2020, and January 23, 2025.
2. Patients aged between 19 and 79 years.
3. Patients with a renal tumor measuring ≤10 cm in maximum diameter on preoperative CT imaging.
4. Patients with a RENAL Nephrometry Score between 4 and 12.

Exclusion Criteria [Experimental Group]

1. Patients who do not consent to participate in the clinical trial.
2. Patients whose CT examination does not follow the required protocol for image analysis.
3. Patients with a history of abdominal surgery likely to cause severe adhesions.
4. Patients with a solitary kidney or horseshoe kidney as identified on preoperative CT.
5. Patients scheduled for bilateral nephrectomy.
6. Patients requiring simultaneous resection of other organs in addition to nephrectomy.
7. Patients with a history of abdominal surgery where severe adhesions are expected based on the investigator's judgment.
8. Patients with severe renal dysfunction at the time of screening (serum creatinine level ≥1.5 times the upper limit of normal for the study site) or CKD stage 3 (eGFR <60).
9. Patients classified as ASA (American Society of Anesthesiologists Physical Status Classification) IV-VI.
10. Patients with a history of psychiatric disorders, alcohol abuse, or other conditions that, in the investigator's judgment, make clinical trial participation inappropriate.
11. Patients who have participated in or are scheduled to participate in another clinical trial (medical device or pharmaceutical) within four weeks prior to screening.
12. Patients deemed unsuitable for clinical trial participation at the investigator's discretion.
13. Patients whose CT images are not suitable for generating 3D images for use with the investigational medical device.

[Control Group]

1. Patients whose CT data are unavailable.
2. Patients with a history of abdominal surgery with expected or confirmed severe adhesions.
3. Patients with a solitary kidney or horseshoe kidney.
4. Patients who have undergone bilateral nephrectomy.
5. Patients who have undergone simultaneous resection of other organs in addition to nephrectomy.
6. Patients with renal dysfunction (serum creatinine level ≥1.5 times the upper limit of normal for the study site) or CKD stage 3 (eGFR <60).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RUS NE Group; Individuals undergo robot-assisted partial nephrectomy using RUS NE	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.
No Intervention: Standard Surgery Group; Individuals undergo robot-assisted partial nephrectomy without using RUS NE. The individuals of this group were selected from the historical group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resection volume	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.	At the time of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operative time	The total amount time for robot-assisted partial nephrectomy, including the time for surgical console manipulation	At the time of surgery

Collaborators and Investigators

• Sponsor: Hutom Corp
• Collaborators: Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Actual): June 10, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: April 10, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Estimated): September 16, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Kidney Neoplasms; Nephrectomy; Robot-assisted partial nephrectomy; Image-Guided Surgery; Surgical Navigation Systems
• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Kidney Neoplasms
• Other Study ID Numbers: 2025-0278; A20250116 (Other Grant/Funding Number: Global innovative medical technology verification support at AMC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No