A Multicenter Study of RUS NE
ConditionRenal Tumors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19-80
SponsorHutom Corp
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
RUS NE
DeviceThe 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.
Treatment groups
204 Participants
are divided into 2 treatment groupsGroup A: Experimental GroupExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Operative time
The duration of time between starting a surgical incision to the last sutures of the operation.
Time frame
The operative day (operative day ± 5 days)Secondary outcomes
1
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
Time frame
The operative day (operative day ± 5 days)2
Resection volume
Calculated from the 3-dimensional lengths from the resected renal specimen using ellipsoid formula (π/6XYZ)
Time frame
From the postoperative 1week to the postoperative 5 weeks3
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.
Time frame
From the postoperative 8 weeks to the postoperative 16 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hutom Corp
Lead sponsor
Asan Medical Center
Collaborator
Seoul National University Hospital
Collaborator
Samsung Medical Center
Collaborator
Chonnam National University Hospital
Collaborator
Kyungpook National University Hospital
Collaborator
Severance Hospital
Collaborator
Source ClinicalTrials.gov