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

Launched by HUTOM CORP · Apr 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new surgical navigation system called 'RUS NE' that is used during robot-assisted partial nephrectomy, which is a type of surgery to remove part of a kidney affected by cancer. The trial aims to find out if this new system is safe, effective, and reliable compared to standard surgery methods. Researchers will look at various health indicators during and after surgery to see how well the 'RUS NE' system works.

To participate in this trial, patients must be between 20 and 80 years old, diagnosed with renal cancer, and scheduled for surgery using the 'RUS NE' system. They should have a kidney tumor that is 10 cm or smaller and meet certain health criteria. Participants will need to agree to join the study and sign a consent form. It's important to note that this trial is not yet recruiting participants, but it will help improve surgical techniques in the future.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• • \[Experimental Group\]
• • 1. Patients diagnosed with renal cancer scheduled for robot-assisted partial nephrectomy using the RUS system, aged between 20 and 80 years.
• • 2. Patients who voluntarily consent to participate in this clinical trial and sign the written informed consent form.
• • 3. Patients with a renal tumor measuring ≤10 cm in maximum diameter on preoperative CT imaging.
• • 4. Patients with a RENAL Nephrometry Score between 4 and 12.
• • \[Control Group\]
• • 1. 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.
• • 2. Patients aged between 19 and 79 years.
• • 3. Patients with a renal tumor measuring ≤10 cm in maximum diameter on preoperative CT imaging.
• • 4. Patients with a RENAL Nephrometry Score between 4 and 12.
• • Exclusion Criteria \[Experimental Group\]
• • 1. Patients who do not consent to participate in the clinical trial.
• • 2. Patients whose CT examination does not follow the required protocol for image analysis.
• • 3. Patients with a history of abdominal surgery likely to cause severe adhesions.
• • 4. Patients with a solitary kidney or horseshoe kidney as identified on preoperative CT.
• • 5. Patients scheduled for bilateral nephrectomy.
• • 6. Patients requiring simultaneous resection of other organs in addition to nephrectomy.
• • 7. Patients with a history of abdominal surgery where severe adhesions are expected based on the investigator's judgment.
• • 8. 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).
• • 9. Patients classified as ASA (American Society of Anesthesiologists Physical Status Classification) IV-VI.
• • 10. Patients with a history of psychiatric disorders, alcohol abuse, or other conditions that, in the investigator's judgment, make clinical trial participation inappropriate.
• • 11. Patients who have participated in or are scheduled to participate in another clinical trial (medical device or pharmaceutical) within four weeks prior to screening.
• • 12. Patients deemed unsuitable for clinical trial participation at the investigator's discretion.
• • 13. Patients whose CT images are not suitable for generating 3D images for use with the investigational medical device.
• • \[Control Group\]
• • 1. Patients whose CT data are unavailable.
• • 2. Patients with a history of abdominal surgery with expected or confirmed severe adhesions.
• • 3. Patients with a solitary kidney or horseshoe kidney.
• • 4. Patients who have undergone bilateral nephrectomy.
• • 5. Patients who have undergone simultaneous resection of other organs in addition to nephrectomy.
• • 6. 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).