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NCT Number: NCT06868186

A Multicenter Study of RUS NE

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

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Key information

Conditions

Renal Tumors Adenocarcinoma Carcinoma Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chonnam National University Hospital, Kwangju, Jeollanam-do, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RUS NE

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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)

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheryn Song, M.D.,Ph.D.

CONTACT

[email protected]

82-2-3010-5992

Suh Min Kim, M.D.,Ph.D.

CONTACT

[email protected]

82-2-6956-0426

Sponsors and collaborators

Lead sponsor

Hutom Corp

Industry

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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