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A Multicenter Study of RUS NE

RecruitingNAAges 19 Years - 80 YearsAllHutom Corp
NCT06868186 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • RUS NE
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Where

4 sites
Chonnam National University Hospital
Kwangju, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Severance Hospital
Seoul, South Korea
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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