RECRUITINGINTERVENTIONAL

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

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form form Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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, the surgeon uses RUS NE as a surgical navigation tool to simulate the surgery before performing the actual procedure.

Locations (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