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Kidney NeoplasmHTK_002NCT06945640

Evaluation of 'RUS NE' in Robot-Assisted Partial Nephrectomy: Efficacy, Safety, and Stability

A study testing RUS NE in people with Kidney Neoplasm and Nephrectomy, run by Hutom Corp at 1 site in South Korea.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study is a retrospective and prospective comparative study evaluating the efficacy, safety, and stability of the surgical navigation system 'RUS NE' in robot-assisted partial nephrectomy. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
RUS NE
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSouth Korea
Study dates
30 Apr 2025to Feb 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • [Experimental Group]
  • Patients diagnosed with renal cancer scheduled for robot-assisted partial nephrectomy using the RUS system, aged between 20 and 80 years.
  • Patients who voluntarily consent to participate in this clinical trial and sign the written informed consent form.
  • Patients with a renal tumor measuring ≤10 cm in maximum diameter on preoperative CT imaging.
  • Patients with a RENAL Nephrometry Score between 4 and 12.
  • [Control Group]
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  • Patients diagnosed with renal cancer who underwent robot-assisted partial nephrectomy using the standard surgical method at the institution between January 1, 2020, and January 23, 2025.
  • Patients aged between 19 and 79 years.
  • Patients with a renal tumor measuring ≤10 cm in maximum diameter on preoperative CT imaging.
  • Patients with a RENAL Nephrometry Score between 4 and 12.

Who cannot join

  • Patients who do not consent to participate in the clinical trial.
  • Patients whose CT examination does not follow the required protocol for image analysis.
  • Patients with a history of abdominal surgery likely to cause severe adhesions.
  • Patients with a solitary kidney or horseshoe kidney as identified on preoperative CT.
  • Patients scheduled for bilateral nephrectomy.
  • Patients requiring simultaneous resection of other organs in addition to nephrectomy.
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  • Patients with a history of abdominal surgery where severe adhesions are expected based on the investigator's judgment.
  • Patients with severe renal dysfunction at the time of screening (serum creatinine level ≥1.5 times the upper limit of normal for the study site) or CKD stage 3 (eGFR <60).
  • Patients classified as ASA (American Society of Anesthesiologists Physical Status Classification) IV-VI.
  • Patients with a history of psychiatric disorders, alcohol abuse, or other conditions that, in the investigator's judgment, make clinical trial participation inappropriate.
  • Patients who have participated in or are scheduled to participate in another clinical trial (medical device or pharmaceutical) within four weeks prior to screening.
  • Patients deemed unsuitable for clinical trial participation at the investigator's discretion.
  • Patients whose CT images are not suitable for generating 3D images for use with the investigational medical device.
  • [Control Group]
  • Patients whose CT data are unavailable.
  • Patients with a history of abdominal surgery with expected or confirmed severe adhesions.
  • Patients with a solitary kidney or horseshoe kidney.
  • Patients who have undergone bilateral nephrectomy.
  • Patients who have undergone simultaneous resection of other organs in addition to nephrectomy.
  • Patients with renal dysfunction (serum creatinine level ≥1.5 times the upper limit of normal for the study site) or CKD stage 3 (eGFR <60).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

South Korea1 site

  • Asan Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Evaluation of the Efficacy, Safety, and Stability of the Surgical Navigation System 'RUS NE' in Robot-Assisted Partial Nephrectomy: A Retrospective and Prospective Comparative Study

This study is a retrospective and prospective comparative study evaluating the efficacy, safety, and stability of the surgical navigation system 'RUS NE' in robot-assisted partial nephrectomy. The study aims to compare intraoperative and postoperative clinical indicators between the experimental group and the control group to verify the clinical effectiveness and stability of RUS NE. This research is conducted as part of the 2025 Corporate Verification Support Project of the Global Innovative Medical Technology Verification Support Center at Asan Medical Center (ARIS Project Number: A20250116) and is supported by the Korea Health Industry Development Institute's healthcare technology research and development program.

Read the detailed description
  1. Study Objectives
  2. Efficacy Evaluation: Comparison of resection volume, operative time, and blood loss between the experimental group (RUS NE-assisted) and the control group (standard procedure).
  • Analysis of whether RUS NE facilitates accurate tumor localization to minimize resection margins.
  1. Stability Evaluation: Validation of CT turn-around time, accuracy of 3D image reconstruction, and system functionality.
  • Assessment of the device's reliability and stability in a real surgical environment.
  1. Study Methods
  • Study Design: Retrospective and prospective, single-center, comparative study.
  • Study Population: Patients scheduled for robot-assisted partial nephrectomy.
  • Study Period: From IRB approval to December 31, 2025.
  • Sample Size: 80 patients (20 in the experimental group, 60 in the control group).
  • Control group selection: Propensity Score Matching (1:3) applied to match previously treated patients.
  1. Study Endpoints Primary Endpoint: Resection volume: To assess renal function preservation. Secondary Endpoints: Operative time, stage-specific time, blood loss, hospital stay, and postoperative complications.

Stability Evaluation: CT turn-around time, accuracy of 3D modeling, and adequacy of vascular and tumor reconstruction.

Being tested
RUS NE
Keywords
Kidney Neoplasms, Nephrectomy, Image-Guided Surgery, Surgical Navigation Systems, Robot-assisted partial nephrectomy
Medical subject headings
Kidney Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RUS NEDevice

    RUS NE is a surgical navigation system designed for use in robot-assisted partial nephrectomy. It reconstructs CT images into 3D models, providing visualization of tumor and vascular structures to enhance surgical precision and optimize resection planning. This system aids in reducing resection volume and improving operative outcomes by integrating anatomical insights into the surgical workflow.

Study groups in NCT06945640
Study groupRoleWhat they receive
RUS NE GroupExperimentalIndividuals undergo robot-assisted partial nephrectomy using RUS NE
Receives: Device: RUS NE
Standard Surgery GroupNo interventionIndividuals undergo robot-assisted partial nephrectomy without using RUS NE. The individuals of this group were selected from the historical group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Resection volume

    Resection volume were measured by ellipsoid formula. The maximum longitudinal length of the resected kidney specimen is measured along the X-axis, with perpendicular measurements taken along the Y and Z axes. The volume is estimated using the formula: (π/6) × X × Y × Z.

    Measured: At the time of surgery

Secondary outcomes (1)

  1. Operative time

    The total amount time for robot-assisted partial nephrectomy, including the time for surgical console manipulation

    Measured: At the time of surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2025
  2. Study start30 Apr 2025
  3. Primary completion10 Jun 2025
  4. Study completionFeb 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06945640
Sponsor's protocol ID
2025-0278
Other IDs
A20250116
Acronym
HTK_002
Status last verified
Apr 2025
First submitted
10 Apr 2025
Last updated
16 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing RUS NE in people with Kidney Neoplasm and Nephrectomy, run by Hutom Corp at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Resection volume (time frame: At the time of surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06945640.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.

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