| NCT ID | NCT06868186 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hutom Corp |
| Condition | Renal Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 204 participants |
| Start Date | 2025-04-29 |
| Primary Completion | 2025-08-29 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 204 participants in total. It began in 2025-04-29 with a primary completion date of 2025-08-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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 o
Frequently Asked Questions
Who can join the NCT06868186 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, up to 80 Years, studying Renal Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06868186 currently recruiting?
Yes, NCT06868186 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hutom Corp to inquire about joining.
Where is the NCT06868186 trial being conducted?
This trial is being conducted at Kwangju, South Korea, Seoul, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT06868186 clinical trial?
NCT06868186 is sponsored by Hutom Corp. The trial plans to enroll 204 participants.