Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Tumors | Kidney Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RUS NE | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental Group
- description
- Experimental group will undergo robot-assisted partial nephrectomy for renal tumor using RUS NE.
- interventionNames
- Device: RUS NE
- type
- NO_INTERVENTION
- label
- Control arm
- description
- Experimental group will undergo robot-assisted partial nephrectomy for renal tumor without using RUS NE.
Primary outcomes (1)
- measure
- Operative time
- timeFrame
- The operative day (operative day ± 5 days)
- description
- The duration of time between starting a surgical incision to the last sutures of the operation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTLee 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