A Multicenter Study of RUS NE

Not Applicable

Not yet recruiting

• Conditions: Renal Tumors

• Registration Number: NCT06868186
• Lead Sponsor: Hutom Corp

Brief Summary

This sponsor-initiated, randomized controlled clinical trial aims to demonstrate the clinical efficacy of RUS NE Surgical Navigation System in patients undergoing robotic-assisted partial nephrectomy. The trial will compare the experimental group (n=102) using RUS NE with a control group (n=102), aiming to show an 10% reduction in operation time. The study will involve 6 medical centers in South Korea in patient recruitment and evaluate the clinical efficacy and feasibility of the software, which has been shown to be reliable in previous studies.

* Investigational Medical Device: RUS NE (Endoscopic Imaging Treatment Planning Software)

* Clinical Trial duration: 24 months from IRB approval -Target number of subjects: Total of 204 participants

Detailed Description

After selecting subjects and obtaining informed consent, randomization will be conducted. Robot-assisted partial nephrectomy will be performed using RUS NE or without using software. Parameters-associated with operation or clinical outcomes will be evaluated during hospitalization period or through outpatient follow-ups for up to 3 months after discharge.

Study Timeline

• Study First Submitted: 2025-02-28
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-16
• Last Update Posted: 2025-04-22
• Study Start: 2025-05-01
• Primary Completion: 2025-05-01
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 204

Inclusion Criteria

• Individuals who were diagnosed with renal tumor and undergo robot-assisted partial nephrectomy
• The diameter of renal tumor is 7cm or below
• Individuals aged between 19 and 80
• Individuals who, before participating in the clinical trial, undergo an interview in a separate place, understand sufficient explanation of the purpose and content of the trial, and voluntarily sign informed consent form

Exclusion Criteria

• Individuals with solitary kidney or horseshoe kidney
• Individuals undergo bilateral nephrectomy
• Individuals undergo operation other than partial nephrecotmy
• Individuals with a history of abdominal surgery and are expected to have severe intra-abdominal adhesion influencing the surgical outcomes
• Individuals with severe chronic kidney disease (eGFR < 45, calculated with EPI-CKI equation)
• Individuals with American society of anesthesiologists physical status classification (ASA) IV-VI
• Individuals with a history of psychosis, alcohol abuse or are expected not to adhere to the schedule of the clinical study
• Individuals who were participated in other clinical study within 4 weeks of screening
• Individuals who are thought to be inappropriate to participate to the clinical trial by the investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Operative time	The operative day (operative day ± 5 days)	The duration of time between starting a surgical incision to the last sutures of the operation.

Secondary Outcome Measures

Name	Time	Method
Tumor and vessel identification time	The operative day (operative day ± 5 days)	The duration of time between starting manipulation of the surgeon console to the finishing dissection of the hilum and perinephric fat
Resection volume	From the postoperative 1week to the postoperative 5 weeks	Calculated from the 3-dimensional lengths from the resected renal specimen using ellipsoid formula (π/6XYZ)
Postoperative complications	From the postoperative 8 weeks to the postoperative 16 weeks	Incidence of postoperative complications occurred within 4 weeks after the operation. The complications include urine leak, acute kidney injury, renal hemorrhage, fluid collection, abscess, and pulmonary or cardiac complications.

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of