Intrarenal Pressure Monitoring Via Flexible and Navigable Suction Ureteral Access Sheath in Retrograde Intrarenal Surgery: A Pilot Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Operative Time
研究概览
简要总结
This study evaluates the use of a novel intrarenal pressure (IRP)-monitoring flexible and navigable suction ureteral access sheath (FANS) in retrograde intrarenal surgery (RIRS) for renal stones. The prospective clinical trial compares its efficacy and safety against conventional FANS in 100 patients. The primary outcomes include IRP monitoring accuracy, operative time, stone-free rate (SFR), and complication rates, with the aim of improving stone retrieval efficiency and procedural safety in RIRS. This trial seeks to validate the innovative device's role in expanding RIRS indications, especially for large renal stones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18-75 years old) diagnosed with renal stones (size ≤4 cm) and suitable for retrograde intrarenal surgery (RIRS).
- •Willing to provide informed consent.
- •No significant renal, cardiac, or systemic diseases that may interfere with the surgical procedure or the study.
- •Preoperative intravenous pyelography (IVP) showing no significant ureteral stricture.
排除标准
- •Patients with active urinary tract infections (UTIs) or fever at the time of surgery.
- •Pregnancy or breastfeeding women.
- •Patients with a history of severe renal disease (e.g., chronic kidney disease stage 3 or higher).
- •History of prior ureteral or renal surgery that may affect the anatomy.
- •Patients with uncontrolled comorbidities such as uncontrolled diabetes, hypertension, or cardiovascular disease.
- •Patients who are unwilling or unable to comply with the study protocol.
结局指标
主要结局
Operative Time
时间窗: Measured during the surgical procedure, from the start of the surgery to the end of the procedure (estimated duration: 30-60 minutes per patient).
The primary outcome will be the total operative time, measured from the insertion of the endoscope into the urethra to the completion of stent placement. This outcome will assess the efficiency of stone retrieval when using either the IRP-monitoring FANS or the conventional FANS.
次要结局
- Stone-Free Rate (SFR)(24-48 hours post-surgery, based on CT scan results.)
- Postoperative Complications(Evaluated within 30 days post-surgery.)
研究者
Guohua Zeng
Vice president
The First Affiliated Hospital of Guangzhou Medical University