Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
204 participants
INTERVENTIONAL
2025-04-29
2026-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* 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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of 'RUS NE' in Robot-Assisted Partial Nephrectomy: Efficacy, Safety, and Stability
NCT06945640
a Prospective Trial Comparing Robot-assisted Partial Nephrectomy Versus Laparoscopic Partial Nephrectomy
NCT03900364
Effects of Recruitment Maneuver in Patients Undergoing Robotic Assisted Radical Prostatectomy
NCT02013011
Robot-assisted Laparoscopic Partial Nephrectomy Via the Extraperitoneal Approach in the Prone Position Versus the Lateral Position
NCT06572501
Single-Port RAS Using Da Vinci SP Surgical System for UTUC Patients
NCT06987552
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Experimental Group
Experimental group will undergo robot-assisted partial nephrectomy for renal tumor using RUS NE.
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.
Control arm
Experimental group will undergo robot-assisted partial nephrectomy for renal tumor without using RUS NE.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
19 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Asan Medical Center
OTHER
Seoul National University Hospital
OTHER
Samsung Medical Center
OTHER
Chonnam National University Hospital
OTHER
Kyungpook National University Hospital
OTHER
Severance Hospital
OTHER
Hutom Corp
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Cheryn Song, M.D.,Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chonnam National University Hospital
Kwangju, Jeollanam-do, South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HTK-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.