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
Hutom Corp
204 participants
Apr 29, 2025
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria4
- 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 Criteria9
- 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
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.
Locations(4)
View Full Details on ClinicalTrials.gov
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NCT06868186