A Multicenter Study of RUS NE

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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

Primary outcome measure(s)

• Operative time — The operative day (operative day ± 5 days)
  The duration of time between starting a surgical incision to the last sutures of the operation.

Trial sites (4)

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