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

NCT06945640 | Enrolling By Invitation

• 2 other identifiers: 2025-0278A20250116
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Kidney Neoplasms; Nephrectomy; Image-Guided Surgery; Surgical Navigation Systems; Robot-assisted partial nephrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Operative time

  At the time of surgery

Study Arms (2)

RUS NE Group

EXPERIMENTAL

Individuals undergo robot-assisted partial nephrectomy using RUS NE

Device: RUS NE

Standard Surgery Group

NO INTERVENTION

Individuals undergo robot-assisted partial nephrectomy without using RUS NE. The individuals of this group were selected from the historical group.

Interventions

RUS NE DEVICE

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.

RUS NE Group

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \[Experimental Group\]
• Patients diagnosed with renal cancer scheduled for robot-assisted partial nephrectomy using the RUS system, aged between 20 and 80 years.
• Patients who voluntarily consent to participate in this clinical trial and sign the written informed consent form.
• Patients with a renal tumor measuring ≤10 cm in maximum diameter on preoperative CT imaging.
• Patients with a RENAL Nephrometry Score between 4 and 12.
• \[Control Group\]
• 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.
• Patients aged between 19 and 79 years.
• Patients with a renal tumor measuring ≤10 cm in maximum diameter on preoperative CT imaging.
• Patients with a RENAL Nephrometry Score between 4 and 12.

You may not qualify if:

• Patients who do not consent to participate in the clinical trial.
• Patients whose CT examination does not follow the required protocol for image analysis.
• Patients with a history of abdominal surgery likely to cause severe adhesions.
• Patients with a solitary kidney or horseshoe kidney as identified on preoperative CT.
• Patients scheduled for bilateral nephrectomy.
• Patients requiring simultaneous resection of other organs in addition to nephrectomy.
• Patients with a history of abdominal surgery where severe adhesions are expected based on the investigator's judgment.
• 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).
• Patients classified as ASA (American Society of Anesthesiologists Physical Status Classification) IV-VI.
• Patients with a history of psychiatric disorders, alcohol abuse, or other conditions that, in the investigator's judgment, make clinical trial participation inappropriate.
• Patients who have participated in or are scheduled to participate in another clinical trial (medical device or pharmaceutical) within four weeks prior to screening.
• Patients deemed unsuitable for clinical trial participation at the investigator's discretion.
• Patients whose CT images are not suitable for generating 3D images for use with the investigational medical device.
• \[Control Group\]
• Patients whose CT data are unavailable.

Sponsors & Collaborators

• Hutom Corp: lead
• Asan Medical Center: collaborator

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 25, 2025
• Study Start: April 30, 2025
• Primary Completion: June 10, 2025
• Study Completion: February 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-04

Locations

KR (1)