Evaluation of 'RUS NE' in Robot-Assisted Partial Nephrectomy: Efficacy, Safety, and Stability

• Study Objectives

• Efficacy Evaluation: Comparison of resection volume, operative time, and blood loss between the experimental group (RUS NE-assisted) and the control group (standard procedure).

o Analysis of whether RUS NE facilitates accurate tumor localization to minimize resection margins.

• Stability Evaluation: Validation of CT turn-around time, accuracy of 3D image reconstruction, and system functionality.

• Assessment of the device's reliability and stability in a real surgical environment.
• Study Methods

• Study Design: Retrospective and prospective, single-center, comparative study.
• Study Population: Patients scheduled for robot-assisted partial nephrectomy.
• Study Period: From IRB approval to December 31, 2025.

• Sample Size: 80 patients (20 in the experimental group, 60 in the control group).
• Control group selection: Propensity Score Matching (1:3) applied to match previously treated patients.
• Study Endpoints Primary Endpoint: Resection volume: To assess renal function preservation. Secondary Endpoints: Operative time, stage-specific time, blood loss, hospital stay, and postoperative complications.

Stability Evaluation: CT turn-around time, accuracy of 3D modeling, and adequacy of vascular and tumor reconstruction.

Inclusion criteria

[Experimental Group]

• Patients diagnosed with renal cancer scheduled for robot-assisted partial nephrectomy using the RUS system, aged between 20 and 80 years.
• Patients who voluntarily consent to participate in this clinical trial and sign the written informed consent form.
• Patients with a renal tumor measuring ≤10 cm in maximum diameter on preoperative CT imaging.
• Patients with a RENAL Nephrometry Score between 4 and 12.

[Control Group]

• Patients diagnosed with renal cancer who underwent robot-assisted partial nephrectomy using the standard surgical method at the institution between January 1, 2020, and January 23, 2025.
• Patients aged between 19 and 79 years.
• Patients with a renal tumor measuring ≤10 cm in maximum diameter on preoperative CT imaging.
• Patients with a RENAL Nephrometry Score between 4 and 12.

Exclusion criteria

[Experimental Group]

• Patients who do not consent to participate in the clinical trial.
• Patients whose CT examination does not follow the required protocol for image analysis.
• Patients with a history of abdominal surgery likely to cause severe adhesions.
• Patients with a solitary kidney or horseshoe kidney as identified on preoperative CT.
• Patients scheduled for bilateral nephrectomy.
• Patients requiring simultaneous resection of other organs in addition to nephrectomy.
• Patients with a history of abdominal surgery where severe adhesions are expected based on the investigator's judgment.
• Patients with severe renal dysfunction at the time of screening (serum creatinine level ≥1.5 times the upper limit of normal for the study site) or CKD stage 3 (eGFR <60).
• Patients classified as ASA (American Society of Anesthesiologists Physical Status Classification) IV-VI.
• Patients with a history of psychiatric disorders, alcohol abuse, or other conditions that, in the investigator's judgment, make clinical trial participation inappropriate.
• Patients who have participated in or are scheduled to participate in another clinical trial (medical device or pharmaceutical) within four weeks prior to screening.
• Patients deemed unsuitable for clinical trial participation at the investigator's discretion.
• Patients whose CT images are not suitable for generating 3D images for use with the investigational medical device.

[Control Group]

• Patients whose CT data are unavailable.
• Patients with a history of abdominal surgery with expected or confirmed severe adhesions.
• Patients with a solitary kidney or horseshoe kidney.
• Patients who have undergone bilateral nephrectomy.
• Patients who have undergone simultaneous resection of other organs in addition to nephrectomy.
• Patients with renal dysfunction (serum creatinine level ≥1.5 times the upper limit of normal for the study site) or CKD stage 3 (eGFR <60).