Clinical trial NCT06868186: A Multicenter Study of RUS NE
Official title: A Multicenter, Randomized, Parallel-group Study to Evaluate Efficacy of Surgical Navigation System 'RUS NE' in Patient Underwent Robot-assisted Partial Nephrectomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Renal Tumors
Keywords: renal tumor
robot assisted partial nephrectomy
3D model
surgical navigation
Lead sponsor: Hutom Corp
Sponsor class: INDUSTRY
Collaborators: name: Asan Medical Center
name: Seoul National University Hospital
name: Samsung Medical Center
name: Chonnam National University Hospital
name: Kyungpook National University Hospital
name: Severance Hospital
First posted: 2025-03-10
Enrollment: 204
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: After selecting subjects and obtaining informed consent, randomization will be conducted. Robot-assisted partial nephrectomy will be performed using RUS NE or without using software. Parameters-associated with operation or clinical outcomes will be evaluated during hospitalization period or through outpatient follow-ups for up to 3 months after discharge.

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

Primary outcomes:
measure: Operative time
timeFrame: The operative day (operative day ± 5 days)
Secondary outcomes:
measure: Tumor and vessel identification time
timeFrame: The operative day (operative day ± 5 days)
measure: Resection volume
timeFrame: From the postoperative 1week to the postoperative 5 weeks
measure: Postoperative complications
timeFrame: From the postoperative 8 weeks to the postoperative 16 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Cheryn Song, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lee S, Lee HY, Song C. Assessment of Feasibility and Outcomes of RUS Surgical Navigation System During Robot-Assisted Partial Nephrectomy for Small Renal Masses. Int J Urol. 2025 May;32(5):576-583. doi: 10.1111/iju.70014. Epub 2025 Feb 13.