A Multicenter, Randomized, Parallel-group Study to Evaluate Efficacy of Surgical Navigation System 'RUS NE' in Patient Underwent Robot-assisted Partial Nephrectomy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 204
- 试验地点
- 4
- 主要终点
- Operative time
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Operative time
时间窗: The operative day (operative day ± 5 days)
The duration of time between starting a surgical incision to the last sutures of the operation.
次要结局
- Tumor and vessel identification time(The operative day (operative day ± 5 days))
- Resection volume(From the postoperative 1week to the postoperative 5 weeks)
- Postoperative complications(From the postoperative 8 weeks to the postoperative 16 weeks)