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A Multicenter Study of RUS NE

NCT06868186 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2025-09-11

No results posted yet for this study

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

Conditions

  • Renal Tumors

Interventions

DEVICE

RUS NE

The RUS NE is an endoscopic imaging treatment planning software program. It creates a patient-specific simulation of the intra-abdominal surgical environments, allowing for the visualization of tumor, vascular structures and intra-abdominal organs during the surgical planning process and the operation. RUS NE utilizes preoperative CT images of the patients to segment tumor, organs, and blood vessels and reconstructs them into a 3D model. Although there is no direct intervention on the patient, the surgeon uses RUS NE as a surgical navigation tool to simulate the surgery before performing the actual procedure.

Sponsors & Collaborators

  • Asan Medical Center

    collaborator OTHER

  • Seoul National University Hospital

    collaborator OTHER

  • Samsung Medical Center

    collaborator OTHER

  • Chonnam National University Hospital

    collaborator OTHER

  • Kyungpook National University Hospital

    collaborator OTHER

  • Severance Hospital

    collaborator OTHER

  • Hutom Corp

    lead INDUSTRY

Principal Investigators

  • Cheryn Song, M.D.,Ph.D. · Asan Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-29
Primary Completion
2025-08-29
Completion
2026-04-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06868186 on ClinicalTrials.gov