A Multicenter, Randomized, Parallel-group Study to Evaluate Efficacy of Surgical Navigation System 'RUS NE' in Patient Underwent Robot-assisted Partial Nephrectomy

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Chonnam National University Hospital
RECRUITING
Kwangju
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
Cheryn Song, M.D.,Ph.D.
cherynsong@amc.seoul.kr
82-2-3010-5992
Backup
Suh Min Kim, M.D.,Ph.D.
smkim@hutom.co.kr
82-2-6956-0426
Time Frame
Start Date: 2025-04-29
Estimated Completion Date: 2026-04-30
Participants
Target number of participants: 204
Treatments
Experimental: Experimental Group
Experimental group will undergo robot-assisted partial nephrectomy for renal tumor using RUS NE.
No_intervention: Control arm
Experimental group will undergo robot-assisted partial nephrectomy for renal tumor without using RUS NE.
Related Therapeutic Areas
Sponsors
Collaborators: Seoul National University Hospital, Samsung Medical Center, Asan Medical Center, Chonnam National University Hospital, Severance Hospital, Kyungpook National University Hospital
Leads: Hutom Corp

This content was sourced from clinicaltrials.gov

Similar Clinical Trials