A Multicenter Study of RUS NE
Recruiting now · Not applicable
Conditions studied: Renal Tumors
In brief
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
Key facts
- Study ID
- NCT06868186
- Run by
- Hutom Corp
- People needed
- 204
- Starts
- 2025-04-29
- Expected to finish
- 2026-04-30
- Last updated by the study team
- 2025-09-11
Who can join
Age: 19 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Chonnam National University Hospital — Kwangju, Jeollanam-do, South Korea (enrolling)
- Asan Medical Center — Seoul, South Korea (enrolling)
- Samsung Medical Center — Seoul, South Korea (enrolling)
- Severance Hospital — Seoul, South Korea (enrolling)
Full record on ClinicalTrials.gov
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