The LARC Robot Simplifies Renal Access In Percutaneous Nephrolithotomy (PCNL)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- AdventHealth
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Stone-Free Rate (SFR)
研究概览
简要总结
This study is being done to evaluate a new robotic system that helps urologists more precisely reach the kidney during surgery to remove large kidney stones. The procedure, called percutaneous nephrolithotomy (PCNL), is typically used for people who have large or difficult-to-remove kidney stones.
Traditionally, many urologists rely on radiologists to place a tube into the kidney before surgery. This can cause delays, require multiple procedures, and increase costs. The robotic system being studied - called LARC - is designed to help the urologist safely and accurately guide a needle directly into the kidney during the surgery, without needing a separate procedure beforehand.
The robot uses live X-ray images to help align the instruments. Although parts of the robot have been approved by the U.S. FDA, the version used in this study is still investigational and not yet approved for this specific purpose.
The study will take place at AdventHealth Celebration and include up to 45 adult patients who are scheduled for PCNL surgery. Participants will be followed for up to 1 month after surgery, and doctors will look at outcomes such as the success of the procedure, the number of kidney stones removed, complications, time in surgery, and radiation exposure.
This research may help make kidney stone surgery safer, faster, and more effective in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney stones larger than 2 cm
- •Staghorn renal calculi
- •Lower pole stones less than 2 cm
- •Anatomical abnormalities that reduce the likelihood of spontaneous stone fragment passage, such as:
- •Horseshoe kidney
- •Calyceal diverticulum
- •Ectopic or dystopic kidney
- •Stones that are refractory to prior treatment (e.g., ESWL or ureteroscopy)
- •Suspected malignant tumors or masses located in the planned renal access tract
排除标准
- •Pregnancy
- •Active urinary tract infection (UTI) or untreated sepsis
- •Known bleeding disorders or uncorrectable coagulopathy despite medical management
- •Use of anticoagulant medications (e.g., warfarin, heparin, or DOACs) that cannot be safely discontinued
- •Allergy to contrast media that cannot be pre-medicated or managed
- •Severe cardiopulmonary comorbidities that contraindicate anesthesia or PCNL
- •Inability to provide informed consent
- •Participation in another investigational study that may interfere with study outcomes
结局指标
主要结局
Stone-Free Rate (SFR)
时间窗: Within 30 days post-procedure
Proportion of participants with no residual kidney stones larger than 4 mm, as determined by imaging (non-contrast CT, KUB X-ray, or renal ultrasound).
Procedure Success Rate
时间窗: During procedure (Day 0)
Proportion of procedures in which the urologist was able to successfully obtain renal access and complete the PCNL using the LARC robotic system, without converting to manual or radiologist-assisted access.
次要结局
- Estimated Blood Loss (EBL)(During procedure (Day 0))
- Operative Time(During procedure (Day 0))
- Radiation Exposure(During procedure (Day 0))
- Postoperative Complications(Up to 30 days post-procedure)
- Number of Access Attempts(During procedure (Day 0))