Status:
ENROLLING_BY_INVITATION
Evaluation of 'RUS NE' in Robot-Assisted Partial Nephrectomy: Efficacy, Safety, and Stability
Lead Sponsor:
Hutom Corp
Collaborating Sponsors:
Asan Medical Center
Conditions:
Kidney Neoplasm
Nephrectomy
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief 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 stu...
Detailed Description
1\. Study Objectives 1. Efficacy Evaluation: Comparison of resection volume, operative time, and blood loss between the experimental group (RUS NE-assisted) and the control group (standard procedure)...
Eligibility Criteria
Inclusion
- 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).
Exclusion
Key Trial Info
Start Date :
April 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06945640
Start Date
April 30 2025
End Date
February 1 2026
Last Update
September 16 2025
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea