A Multicenter Study of RUS NE
A Multicenter, Randomized, Parallel-group Study to Evaluate Efficacy of Surgical Navigation System 'RUS NE' in Patient Underwent Robot-assisted Partial Nephrectomy
1 other identifier
interventional
204
1 country
4
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2025
CompletedFirst Posted
Study publicly available on registry
March 10, 2025
CompletedStudy Start
First participant enrolled
April 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2026
CompletedSeptember 11, 2025
August 1, 2025
4 months
February 28, 2025
September 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Operative time
The duration of time between starting a surgical incision to the last sutures of the operation.
The operative day (operative day ± 5 days)
Secondary Outcomes (3)
Tumor and vessel identification time
The operative day (operative day ± 5 days)
Resection volume
From the postoperative 1week to the postoperative 5 weeks
Postoperative complications
From the postoperative 8 weeks to the postoperative 16 weeks
Study Arms (2)
Experimental Group
EXPERIMENTALExperimental group will undergo robot-assisted partial nephrectomy for renal tumor using RUS NE.
Control arm
NO INTERVENTIONExperimental group will undergo robot-assisted partial nephrectomy for renal tumor without using RUS NE.
Interventions
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, the surgeon uses RUS NE as a surgical navigation tool to simulate the surgery before performing the actual procedure.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hutom Corplead
- Asan Medical Centercollaborator
- Seoul National University Hospitalcollaborator
- Samsung Medical Centercollaborator
- Chonnam National University Hospitalcollaborator
- Kyungpook National University Hospitalcollaborator
- Severance Hospitalcollaborator
Study Sites (4)
Chonnam National University Hospital
Kwangju, Jeollanam-do, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Severance Hospital
Seoul, South Korea
Related Publications (1)
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: 39945060BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cheryn Song, M.D.,Ph.D.
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2025
First Posted
March 10, 2025
Study Start
April 29, 2025
Primary Completion
August 29, 2025
Study Completion
April 30, 2026
Last Updated
September 11, 2025
Record last verified: 2025-08