Evaluation of 'RUS NE' in Robot-Assisted Partial Nephrectomy: Efficacy, Safety, and Stability (NCT06945640) | Clinical Trial Compass
By InvitationNot Applicable
Evaluation of 'RUS NE' in Robot-Assisted Partial Nephrectomy: Efficacy, Safety, and Stability
South Korea80 participantsStarted 2025-04-30
Plain-language summary
This study is a retrospective and prospective comparative study evaluating the efficacy, safety, and stability of the surgical navigation system 'RUS NE' in robot-assisted partial nephrectomy. The study aims to compare intraoperative and postoperative clinical indicators between the experimental group and the control group to verify the clinical effectiveness and stability of RUS NE. This research is conducted as part of the 2025 Corporate Verification Support Project of the Global Innovative Medical Technology Verification Support Center at Asan Medical Center (ARIS Project Number: A20250116) and is supported by the Korea Health Industry Development Institute's healthcare technology research and development program.
Who can participate
Age range20 Years ā 80 Years
SexALL
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Inclusion criteria
ā. Patients diagnosed with renal cancer scheduled for robot-assisted partial nephrectomy using the RUS system, aged between 20 and 80 years.
ā. Patients who voluntarily consent to participate in this clinical trial and sign the written informed consent form.
ā. Patients with a renal tumor measuring ā¤10 cm in maximum diameter on preoperative CT imaging.
ā. Patients with a RENAL Nephrometry Score between 4 and 12.
ā. 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.
ā. Patients aged between 19 and 79 years.
ā. Patients with a renal tumor measuring ā¤10 cm in maximum diameter on preoperative CT imaging.
ā. Patients with a RENAL Nephrometry Score between 4 and 12.
Exclusion criteria
ā. Patients who do not consent to participate in the clinical trial.
ā. Patients whose CT examination does not follow the required protocol for image analysis.
ā. Patients with a history of abdominal surgery likely to cause severe adhesions.
ā. Patients with a solitary kidney or horseshoe kidney as identified on preoperative CT.
ā. Patients scheduled for bilateral nephrectomy.
ā. Patients requiring simultaneous resection of other organs in addition to nephrectomy.
ā. Patients with a history of abdominal surgery where severe adhesions are expected based on the investigator's judgment.
ā. Patients with severe renal dysfunction at the time of screening (serum creatinine level ā„1.5 times the upper limit of normal for the study site) or CKD stage 3 (eGFR \<60).