Renal TumorsNCT06868186
A Multicenter Study of RUS NE
A study testing RUS NE in people with Renal Tumors, run by Hutom Corp at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Renal Tumors
- 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
- 204 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 29 Apr 2025to 30 Apr 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
Chonnam National University Hospital
Kwangju, Jeollanam-do
Eu Chang Hwang, 82-61-379-7114, urohwang@gmail.com
- Recruiting
Asan Medical Center
Seoul
Cheryn Song, M.D.,Ph.D., cherynsong@amc.seoul.kr
- Recruiting
Samsung Medical Center
Seoul
minyong Kang, 82-2-3410-1138, dr.minyong.kang@gmail.com
- Recruiting
Severance Hospital
Seoul
Lee, 82-2-2228-1004, LEESEH@yuhs.ac
About this study
Official title: 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
Read the 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.
- Conditions
- Renal Tumors
- Being tested
- RUS NE
- Keywords
- renal tumor, robot assisted partial nephrectomy, 3D model, surgical navigation
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUS NEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Experimental group will undergo robot-assisted partial nephrectomy for renal tumor using RUS NE. Receives: Device: RUS NE |
| Control arm | No intervention | Experimental group will undergo robot-assisted partial nephrectomy for renal tumor without using RUS NE. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
The duration of time between starting a surgical incision to the last sutures of the operation.
Measured: The operative day (operative day ± 5 days)
Secondary outcomes (3)
Tumor and vessel identification time
The duration of time between starting manipulation of the surgeon console to the finishing dissection of the hilum and perinephric fat
Measured: The operative day (operative day ± 5 days)
Resection volume
Calculated from the 3-dimensional lengths from the resected renal specimen using ellipsoid formula (π/6XYZ)
Measured: From the postoperative 1week to the postoperative 5 weeks
Postoperative complications
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.
Measured: From the postoperative 8 weeks to the postoperative 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start29 Apr 2025
- Primary completion29 Aug 2025
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hutom Corp
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center, Seoul National University Hospital, Samsung Medical Center, Chonnam National University Hospital, Kyungpook National University Hospital, Severance Hospital
- Responsible party
- Sponsor
- Investigators
- Cheryn Song, M.D.,Ph.D., Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06868186
- Sponsor's protocol ID
- HTK-001
- Status last verified
- Aug 2025
- First submitted
- 28 Feb 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee S, Lee HY, Song C. Assessment of Feasibility and Outcomes of RUS Surgical Navigation System During Robot-Assisted Partial Nephrectomy for Small Renal Masses. Int J Urol. 2025 May;32(5):576-583. doi: 10.1111/iju.70014. Epub 2025 Feb 13.
PubMed 39945060
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Parallel-group Study to Evaluate Efficacy of Surgical Navigation System 'RUS NE' in Patient Underwent Robot-assisted Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT06868186
- Acronym / sponsor ID
- HTK-001
- Conditions
- Renal Tumors
- Keywords
- renal tumor, robot assisted partial nephrectomy, 3D model, surgical navigation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Hutom CorpIndustry (pharma, biotech, devices)
- Collaborators
- Asan Medical Center, Seoul National University Hospital, Samsung Medical Center, Chonnam National University Hospital, Kyungpook National University Hospital, Severance Hospital
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 10 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: RUS NEExperimental group will undergo robot-assisted partial nephrectomy for renal tumor using RUS NE. |
| Control arm | No intervention | –Experimental group will undergo robot-assisted partial nephrectomy for renal tumor without using RUS NE. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RUS NEThe 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. | Device | Experimental Group |
Primary outcome
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.
3 secondary outcomes
Tumor and vessel identification time
Time frame: The operative day (operative day ± 5 days)
Resection volume
Time frame: From the postoperative 1week to the postoperative 5 weeks
Postoperative complications
Time frame: From the postoperative 8 weeks to the postoperative 16 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Results publication: PubMed 39945060Lee S, Lee HY, Song C. Assessment of Feasibility and Outcomes of RUS Surgical Navigation System During Robot-Assisted Partial Nephrectomy for Small Renal Masses. Int J Urol. 2025 May;32(5):576-583. doi: 10.1111/iju.70014. Epub 2025 Feb 13.
- Individual participant dataSharing planned: Undecided
Related trials for Renal Tumors
Active, not recruitingPhase 1/2
A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024)
Renal Cell Carcinoma
RecruitingObservational study
A Natural History Study of Metabolic Sizing in Health and Disease
Metabolic Disorders, Cancer
RecruitingPhase 2
Testing of Bevacizumab, Erlotinib, and Atezolizumab in Combination for Advanced-Stage Kidney Cancer
Hereditary Leiomyomatosis and Renal Cell Carcinoma, Papillary Renal Cell Carcinoma
Not yet recruiting
A Multicenter Randomized Open-Label Trial Evaluating ctDNA-Guided Interruption Versus Standard of Care Immune-Checkpoint Inhibitor (ICI) Therapy In Patients With Advanced / Metastatic Solid Tumors.
NSCLC (Advanced Non-small Cell Lung Cancer), NSCLC (Non-small Cell Lung Cancer)
Recruiting
Stereotactic Body RadioTherapy With Continuous Tracking for Primary and Secondary Renal Cancer
Renal Cancer, Renal Secondary Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cheryn Song, M.D.,Ph.D. principal investigator
Asan Medical Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RUS NE in people with Renal Tumors, run by Hutom Corp at 4 sites 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 4 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 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 4 sites 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?
Contact Cheryn Song, M.D.,Ph.D. (82-2-3010-5992, cherynsong@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: The operative day (operative day ± 5 days)). 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 NCT06868186, which also lists 1 linked publication.
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 11 Sep 2025.