RecruitingNot ApplicableNCT06868186

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

Sponsor

Hutom Corp

Enrollment

204 participants

Start Date

Apr 29, 2025

Study Type

INTERVENTIONAL

Conditions

Renal Tumors

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

Min Age: 19 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new real-time ultrasound system used during robot-assisted kidney surgery to help surgeons more precisely remove small kidney tumors while preserving as much healthy kidney tissue as possible. **You may be eligible if...** - You have been diagnosed with a kidney tumor - The tumor is 7 cm or smaller - You are between 19 and 80 years old - You are scheduled for robot-assisted partial nephrectomy (a minimally invasive surgery to remove part of the kidney) - You are able to give voluntary informed consent **You may NOT be eligible if...** - Your tumor is larger than 7 cm - You have had previous kidney surgery on the same kidney - You have serious health conditions that make surgery unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERUS 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

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NCT06868186

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