Actively Recruiting
A Multicenter Study of RUS NE
Led by Hutom Corp · Updated on 2025-09-11
204
Participants Needed
4
Research Sites
52 weeks
Total Duration
On this page
Sponsors
H
Hutom Corp
Lead Sponsor
A
Asan Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Multicenter Study of RUS NE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with renal tumor and scheduled for robot-assisted partial nephrectomy
- Renal tumor diameter of 7 cm or below
- Age between 19 and 80 years
- Able to understand the trial and voluntarily sign informed consent before participation
You will not qualify if you...
- Having a solitary kidney or horseshoe kidney
- Undergoing bilateral nephrectomy
- Undergoing surgery other than partial nephrectomy
- History of abdominal surgery with expected severe intra-abdominal adhesion affecting surgical outcomes
- Severe chronic kidney disease (eGFR < 45, calculated with EPI-CKI equation)
- American Society of Anesthesiologists physical status classification IV to VI
- History of psychosis or alcohol abuse, or expected poor adherence to study schedule
- Participation in another clinical study within 4 weeks before screening
- Considered inappropriate for study participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Chonnam National University Hospital
Kwangju, Jeollanam-do, South Korea
Actively Recruiting
2
Asan Medical Center
Seoul, South Korea
Actively Recruiting
3
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
4
Severance Hospital
Seoul, South Korea
Actively Recruiting
Research Team
C
Cheryn Song, M.D.,Ph.D.
CONTACT
S
Suh Min Kim, M.D.,Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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