A Multicenter Study of RUS NE

September 10, 2025 updated by: Hutom Corp

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

204

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Suh Min Kim, M.D.,Ph.D.
  • Phone Number: 82-2-6956-0426
  • Email: smkim@hutom.co.kr

Study Locations

  • South Korea
      • Seoul, South Korea
      • Seoul, South Korea
      • Seoul, South Korea
        • Recruiting
        • Severance Hospital
        • Contact:
    • Jeollanam-do
      • Kwangju, Jeollanam-do, South Korea
        • Recruiting
        • Chonnam National University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
Experimental group will undergo robot-assisted partial nephrectomy for renal tumor using RUS NE.
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.
No Intervention: Control arm
Experimental group will undergo robot-assisted partial nephrectomy for renal tumor without using RUS NE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Operative time
Time Frame: The operative day (operative day ± 5 days)
The duration of time between starting a surgical incision to the last sutures of the operation.
The operative day (operative day ± 5 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor and vessel identification time
Time Frame: 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
The operative day (operative day ± 5 days)
Resection volume
Time Frame: 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)
From the postoperative 1week to the postoperative 5 weeks
Postoperative complications
Time Frame: 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.
From the postoperative 8 weeks to the postoperative 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hutom Corp

Collaborators

Samsung Medical Center
Asan Medical Center
Chonnam National University Hospital
Seoul National University Hospital
Kyungpook National University Hospital
Severance Hospital

Investigators

  • Principal Investigator: Cheryn Song, M.D.,Ph.D., Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 29, 2025

Primary Completion (Actual)

August 29, 2025

Study Completion (Estimated)

April 30, 2026

Study Registration Dates

First Submitted

February 28, 2025

First Submitted That Met QC Criteria

March 5, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 10, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HTK-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Renal Tumors

Clinical Trials on RUS NE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe