NCT06868186Recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 204 (estimated)
- First submitted
- 28 Feb 2025
- Start date
- 29 Apr 2025
- Primary completion date
- 29 Aug 2025
- Lead sponsor
- Hutom Corp
- Diseases
- Kidney cancer
- NCT number
- NCT06868186
What you commit to
- Study type: Interventional
- Planned participants: 204
- From 29 Apr 2025 to the primary completion date, 29 Aug 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Individuals with a history of abdominal surgery and are expected to have severe intra-abdominal adhesion influencing the surgical outcomes
- Individuals with a history of psychosis, alcohol abuse or are expected not to adhere to the schedule of the clinical study
Lab values
- Individuals with severe chronic kidney disease (eGFR \< 45, calculated with EPI-CKI equation)
Other
- Individuals with solitary kidney or horseshoe kidney
- Individuals undergo bilateral nephrectomy
- Individuals undergo operation other than partial nephrecotmy
- Individuals with American society of anesthesiologists physical status classification (ASA) IV-VI
- 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
Who the study is looking for
- 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
Age in the registry: 19 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chonnam National University Hospital Coordinator of this site? Confirm its status | Kwangju | South Korea | Recruiting |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Severance hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.