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Recruiting NCT06868186

A Multicenter Study of RUS NE

No phase Interventional Renal Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: RUS NE.
Who it may be relevant to
Registry conditions: Renal Tumors. Basic parameters: 19 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Randomized, Parallel-group Study to Evaluate Efficacy of Surgical Navigation System 'RUS NE' in Patient Underwent Robot-assisted Partial Nephrectomy

Overview

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

Detailed description

After selecting subjects and obtaining informed consent, randomization will be conducted. Robot-assisted partial nephrectomy will be performed using RUS NE or without using software. Parameters-associated with operation or clinical outcomes will be evaluated during hospitalization period or through outpatient follow-ups for up to 3 months after discharge.

Interventions

  • Device RUS NE
    The RUS NE is an endoscopic imaging treatment planning software program. It creates a patient-specific simulation of the intra-abdominal surgical environments, allowing for the visualization of tumor, vascular structures and intra-abdominal organs during the surgical planning process and the operation. RUS NE utilizes preoperative CT images of the patients to segment tumor, organs, and blood vessels and reconstructs them into a 3D model. Although there is no direct intervention on the patient, t

Primary outcome measures

  • Operative time [Time frame: The operative day (operative day ± 5 days)]
Secondary outcome measures (3)
  • Tumor and vessel identification time [Time frame: The operative day (operative day ± 5 days)]
  • Resection volume [Time frame: From the postoperative 1week to the postoperative 5 weeks]
  • Postoperative complications [Time frame: From the postoperative 8 weeks to the postoperative 16 weeks]

Eligibility criteria

Inclusion criteria

  • Individuals who were diagnosed with renal tumor and undergo robot-assisted partial nephrectomy
  • The diameter of renal tumor is 7cm or below
  • Individuals aged between 19 and 80
  • Individuals who, before participating in the clinical trial, undergo an interview in a separate place, understand sufficient explanation of the purpose and content of the trial, and voluntarily sign informed consent form

Exclusion criteria

  • Individuals with solitary kidney or horseshoe kidney
  • Individuals undergo bilateral nephrectomy
  • Individuals undergo operation other than partial nephrecotmy
  • Individuals with a history of abdominal surgery and are expected to have severe intra-abdominal adhesion influencing the surgical outcomes
  • Individuals with severe chronic kidney disease (eGFR < 45, calculated with EPI-CKI equation)
  • Individuals with American society of anesthesiologists physical status classification (ASA) IV-VI
  • Individuals with a history of psychosis, alcohol abuse or are expected not to adhere to the schedule of the clinical study
  • Individuals who were participated in other clinical study within 4 weeks of screening
  • Individuals who are thought to be inappropriate to participate to the clinical trial by the investigators

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 4 centers
  • Chonnam National University Hospital — Kwangju
  • Asan Medical Center — Seoul
  • Samsung Medical Center — Seoul
  • Severance Hospital — Seoul

Publications

  • Lee S, Lee HY, Song C. Assessment of Feasibility and Outcomes of RUS Surgical Navigation System During Robot-Assisted Partial Nephrectomy for Small Renal Masses. Int J Urol. 2025 May;32(5):576-583. doi: 10.1111/iju.70014. Epub 2025 Feb 13. PMID 39945060

Identifiers

NCT: NCT06868186 · HTK-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗