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

Korábbi kezelés

• Patients requiring simultaneous resection of other organs in addition to nephrectomy.
• 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 who have undergone simultaneous resection of other organs in addition to nephrectomy.

Más betegség

• Patients with a history of abdominal surgery likely to cause severe adhesions.
• Patients with a history of abdominal surgery where severe adhesions are expected based on the investigator's judgment.
• Patients with a history of psychiatric disorders, alcohol abuse, or other conditions that, in the investigator's judgment, make clinical trial participation inappropriate.
• Patients with a history of abdominal surgery with expected or confirmed severe adhesions.

Laborértékek

• 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 with renal dysfunction (serum creatinine level ≥1.5 times the upper limit of normal for the study site) or CKD stage 3 (eGFR <60).

Egyéb

• 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 solitary kidney or horseshoe kidney as identified on preoperative CT.
• Patients scheduled for bilateral nephrectomy.
• Patients classified as ASA (American Society of Anesthesiologists Physical Status Classification) IV-VI.
• 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 solitary kidney or horseshoe kidney.
• Patients who have undergone bilateral nephrectomy.

• [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.