A Multicenter Study of RUS NE

Hutom

Status

Enrolling

Conditions

Renal Tumors

Treatments

Device: RUS NE

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06868186

HTK-001

Details and patient eligibility

About

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

Full 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.

Enrollment

204 estimated patients

Sex

All

Ages

19 to 80 years old

Volunteers

No Healthy Volunteers

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