ClearPetra™ Vacuum-Assisted Ureteral Access Sheath Optimization of Irrigation and Suction Parameters in FANS-Assisted Flexible Ureteroscopy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Stone-Free Rate (SFR)
研究概览
简要总结
Kidney stones are commonly treated with flexible ureteroscopy, a minimally invasive procedure in which a small scope is passed through the urinary tract to reach and treat stones in the kidney. Flexible and navigable suction access sheaths (FANS), such as the ClearPetra™ system, allow irrigation and suction to be used during the procedure to help remove stone fragments.
The purpose of this randomized study is to compare two different irrigation and suction pressure settings used with the ClearPetra™ FANS system during flexible ureteroscopy. Approximately 100 adults undergoing ureteroscopy for kidney stones will be randomly assigned to either a higher-flow setting or a moderate-flow setting. The study will compare stone clearance, operative characteristics, and postoperative outcomes to determine which setting provides the most effective and safe treatment conditions.
详细描述
This is a prospective, single-center, single-blinded, randomized controlled trial evaluating two predefined irrigation and suction pressure configurations using the ClearPetra™ 11/13 Fr Flexible and Navigable Suction Access Sheath (FANS) during retrograde intrarenal surgery (RIRS).
Approximately 100 adult patients undergoing flexible ureteroscopy for treatment of kidney stones with a total stone burden of 1.0 to 2.5 cm will be enrolled. Participants will be randomized in a 1:1 ratio to one of two treatment groups. The high-flow group will undergo RIRS using irrigation at 250 mmHg with an automated irrigation pump and suction at 200 mmHg. The moderate-flow group will undergo RIRS using irrigation at 150 mmHg and suction at 120 mmHg.
The primary objective is to evaluate the effect of these irrigation and suction settings on procedural and postoperative outcomes. The primary outcome is stone-free status assessed by postoperative computed tomography approximately three months after surgery. Stone-free status is defined in the protocol as no residual stone fragments greater than 2 mm.
Secondary outcomes include basket use, total operative time, laser time, total laser energy, and postoperative infection within 30 days. Additional exploratory assessments will evaluate the ability of the FANS sheath to reach the upper and lower pole calyces, sheath length selection, intraoperative deflection characteristics, and the amount of sheath remaining outside the patient during upper-pole access.
Participants will undergo clinical care and follow-up according to standard practice. Follow-up information will be collected approximately three months after surgery, and long-term follow-up will continue for up to 12 months to assess subsequent stone events, additional treatments or reinterventions, and available stone-related imaging.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1Male or female participants aged 18 years or older. 2-Undergoing flexible ureteroscopy for retrograde intrarenal surgery. 3-Total stone burden between 1.0 and 2.5 cm.
排除标准
- •1Undergoing bilateral stone treatment during the same procedure. 2-Known genitourinary anatomical abnormalities. 3-Uncorrected coagulopathy. 4-Urinary diversion. 5-Chronic external urinary catheter. 6-Pregnancy. 7-Immunosuppression. 8-Participation in another clinical research study during the duration of this trial, unless the investigator determines on a case-by-case basis that participation in the other study will not adversely affect the outcomes or integrity of this trial.
研究组 & 干预措施
High-Flow FANS Setting
Participants will undergo retrograde intrarenal surgery (RIRS) using the ClearPetra™ vacuum-assisted ureteral access sheath with irrigation pressure of 250 mmHg using an automated irrigation pump and suction pressure of 200 mmHg.
干预措施: ClearPetra™ FANS - High-Flow Setting (Device)
Moderate-Flow FANS Setting
Participants will undergo retrograde intrarenal surgery (RIRS) using the ClearPetra™ vacuum-assisted ureteral access sheath with irrigation pressure of 150 mmHg using an automated irrigation pump and suction pressure of 120 mmHg.
干预措施: ClearPetra™ FANS - Moderate-Flow Setting (Device)
结局指标
主要结局
Stone-Free Rate (SFR)
时间窗: Approximately 3 months postoperatively
Stone-free status will be assessed using postoperative imaging. Stone free is defined as no residual stone fragments greater than 2 mm visible on imaging. The proportion of participants meeting this definition will be compared between the two study arms.
次要结局
未报告次要终点