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Clinical Trials in South Korea / NCT06945640
Enrolling by invitation Not applicable

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

NCT06945640 · tracked via the Priya Life Science South Korea tracker
Sponsor
Hutom Corp
Phase
Not applicable
Started
2025-04-30
Last updated
2025-09-16

Condition(s) studied

Kidney NeoplasmNephrectomySurgical Navigation SystemsRenal MassRobot-assisted Urological Surgery

Investigational drug(s) / intervention(s)

RUS NE

RUS NE: RUS NE is a surgical navigation system designed for use in robot-assisted partial nephrectomy. It reconstructs CT images into 3D models, providing visualization of tumor and vascular structures to enhance surgical precision and optimize resection planning. This system aids in reducing resection volume and improving operative outcomes by integrating anatomical insights into the surgical workflow.

Study 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.

Eligibility

Sex
ALL
Min age
20 Years
Max age
80 Years
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Asan Medical Center Seoul South Korea

More Hutom Corp trials in South Korea

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06945640 on ClinicalTrials.gov ↗ ← All trials in South Korea