RUS NE surgical navigation for robot-assisted partial nephrectomy
Official title: A Multicenter, Randomized, Parallel-group Study to Evaluate Efficacy of Surgical Navigation System 'RUS NE' in Patient Underwent Robot-assisted Partial Nephrectomy
Run by Hutom Corp · NCT06868186 · Data updated 2026-11-12
This trial will test whether the RUS NE surgical navigation software helps surgeons perform robot-assisted partial nephrectomy faster for adults with renal tumors.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 19 Years to 80 Years |
| Sex | All |
| Enrollment | 204 (estimated) |
| Sponsor | Hutom Corp Industry-sponsored |
| Locations | 4 sites (Kwangju, Jeollanam-do and 3 other locations) |
| Status | Recruiting |
| Started | April 29, 2025 |
| Main results expected | August 29, 2025 |
| Study ends | April 30, 2026 |
| Registry record updated | September 11, 2025 |
| Trial ID | NCT06868186 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 19–80 with a renal tumor 7 cm or smaller who are scheduled for robot-assisted partial nephrectomy and can provide informed consent are the ideal candidates.
✕Probably not a fit
Patients with solitary or horseshoe kidneys, those undergoing bilateral nephrectomy or non-partial procedures, people with severe chronic kidney disease (eGFR <45), high ASA class (IV–V), or expected severe intra-abdominal adhesions are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multicenter, randomized controlled trial enrolling 204 adults with renal tumors undergoing robot-assisted partial nephrectomy across six centers in South Korea. Participants are randomized 1:1 to surgery using the RUS NE endoscopic imaging treatment planning software or to standard robot-assisted partial nephrectomy without the software. The primary target is a 10% reduction in operation time, with intraoperative parameters and clinical outcomes collected during hospitalization and up to three months after discharge. The software has shown reliability in prior studies and the trial will run for 24 months from IRB approval to assess feasibility and clinical efficacy.
Why it matters
Potential benefit: If successful, RUS NE could shorten operation times and improve intraoperative planning, potentially reducing anesthesia exposure and surgical complications for patients.
How similar studies have gone: Prior smaller studies have reported the RUS NE software to be reliable for surgical planning, but randomized data showing improved clinical outcomes are limited.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Chonnam National University Hospital
Kwangju, Jeollanam-do, South Korea Recruiting -
Asan Medical Center
Seoul, South Korea Recruiting -
Samsung Medical Center
Seoul, South Korea Recruiting -
Severance Hospital
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Cheryn Song, M.D.,Ph.D. — Asan Medical Center
- Study coordinator: Cheryn Song, M.D.,Ph.D.
- Email: cherynsong@amc.seoul.kr
- Phone: 82-2-3010-5992
Similar studies
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This project will test whether combining MRI images with tumor biopsy genetics and tissue mapping can help guide treatment choices for adults with small (≤4 cm) kidney tumors who are having surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.