Comparative Study on the Efficacy of the Ureteral Access Sheath With Integrated Suction FANS Versus the Standard Sheath in Patients With Renal Calculi Undergoing Ureterorenoscopy and Laser Lithotripsy: a Prospective, Randomized, Interventional, Single-center Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 134
- 试验地点
- 1
- 主要终点
- Radiological stone-free rate (absence of residual fragments >=4 mm) assessed by low-dose non-contrast CT scan
研究概览
简要总结
This is a prospective, interventional single blinded, randomized, single-center study designed to compare the efficacy of a ureteral access sheath with integrated suction (FANS) versus a standard ureteral access sheath (UAS) in patients undergoing ureterorenoscopy and laser lithotripsy for renal stones. The hypothesis is that the use of the FANS device improves stone-free rates and reduces postoperative infectious complications compared to the standard sheath.
详细描述
Single-center, prospective, randomized, interventional, single blinded study. Participants with renal calculi undergoing ureterorenoscopy and laser lithotripsy will be randomized in a 1:1 ratio to receive either a standard ureteral access sheath (UAS) or the FANS (Flexible and Navigable Suction) sheath. Randomization will be stratified by stone characteristics, specifically stone density (≤1000 vs >1000 HU) and stone volume (<500 vs ≥500 mm³), as recorded on preoperative imaging, to reduce potential imbalance between study arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Participant is willing and able to provide written informed consent before any study-specific procedures are performed.
- •Male or female, aged 18 years or older.
- •Diagnosed with renal calculi ≥5 mm in diameter, confirmed by imaging, and eligible for fURS with laser lithotripsy according to European Association of Urology (EAU) guidelines.
- •In stable general health and fit for elective endoscopic surgery under general anesthesia.
- •Willing and able to comply with all study-related procedures, including follow-up imaging and clinical assessments.
排除标准
- •Solitary kidney (monorenal patients).
- •Untreated positive urine culture or ongoing urinary tract infection not resolved with appropriate antibiotic therapy prior to surgery.
- •Known anatomical abnormalities of the urinary tract that may interfere with ureteroscopic access or device placement (e.g., ureteral stricture, congenital malformations).
- •Pregnancy or breastfeeding at the time of enrollment or planning pregnancy during the study period. In all female patients, a Gravindex test is performed on the day of admission; contraceptive measures are not required
- •Concomitant ureteral stone
- •Ureteral stenosis
- •Known allergy or hypersensitivity to materials used in the investigational or control ureteral access sheath.
- •Any severe comorbid condition (e.g., uncontrolled cardiovascular disease, severe coagulopathy, active malignancy) that in the opinion of the investigator would interfere with study participation or increase procedural risk.
- •Any psychological, cognitive, or social condition that may limit the ability to provide informed consent or comply with follow-up procedures.
研究组 & 干预措施
Standard Ureteral Access Sheath (UAS)
Participants receive the standard ureteral access sheath during ureterorenoscopy and laser lithotripsy.
干预措施: Standard ureteral access sheath (Device)
FANS Ureteral Access Sheath (Elephant-II)
Participants receive the Flexible and Navigable Suction (FANS) ureteral access sheath during ureterorenoscopy and laser lithotripsy.
干预措施: Flexible and Navigable Suction (FANS) Ureteral Access Sheath (Device)
结局指标
主要结局
Radiological stone-free rate (absence of residual fragments >=4 mm) assessed by low-dose non-contrast CT scan
时间窗: Within 3 months (+/- 1 month) post-procedure
Proportion of participants classified as stone-free based on radiological evaluation using low-dose non-contrast computed tomography. Stone-free status is defined as absence of residual stone fragments \>=4 mm.
次要结局
未报告次要终点
研究者
Luca Villa
Medical Doctor
IRCCS San Raffaele