A Multicenter Study of RUS NE

Launched by HUTOM CORP · Mar 5, 2025

Keywords

ClinConnect Summary

This clinical trial is testing a new system called the RUS NE Surgical Navigation System to see if it can help doctors perform kidney surgery more efficiently. The study will involve 204 patients who have been diagnosed with a renal tumor (a tumor in the kidney) and are scheduled to have a specific type of surgery called robotic-assisted partial nephrectomy, where only part of the kidney is removed. The goal is to see if using the RUS NE system can reduce the time it takes to perform the surgery by 10% compared to traditional methods.

To participate, patients need to be between 19 and 80 years old, have a tumor that is 7 cm or smaller, and be able to understand and agree to the study after receiving an explanation. Unfortunately, some individuals won't be able to participate, including those with certain kidney conditions or previous surgeries that could affect the results. If eligible, participants can expect to be part of a study that aims to improve surgical outcomes for future patients. This study will take place over 24 months across six medical centers in South Korea and is currently not recruiting patients yet.

Gender

ALL

Eligibility criteria

• 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