NCT07471711已完成不适用
A Multifunctional Miniature Nephroscope for Percutaneous Nephrolithotomy: Design Features and Initial Linical Exprience
The First Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2022年7月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 216
- 试验地点
- 1
- 主要终点
- Stone-free rate
研究概览
简要总结
The goal of this clinical trial is to introduce a novel multifunctional miniature endoscopic system, namely "Aircraft Nephroscope", for percutaneous nephrolithotomy (PCNL) to treat the patients with urolithiasis. The main questions it aims to answer are:
- Is the "Aircraft Nephroscope" a safe and efficient instrument for PCNL?
- What types of nephrocope the "Aircraft Nephroscope" is and what function does it have? Researchers will observe the surgical outcome through the stone-free rate and compliction rates.
Participants will:
- Undergo PCNL with "Aircraft Nephroscope"
- Follow-up the stone-free rate for 2 weeks after surgery
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serum creatinine (≤200 μmol/l);
- •American Society of Anesthesiology score of 1-3;
- •Agree to undergo PCNL with "Aircraft Nephroscope", provide written informed consent and adhere to the requirements of the trial.
排除标准
- •Patients with histories of renal transplant or urinary diversion;
- •patients with congenital abnormalities;
- •Pregnant patients;
- •Patients with uncorrected coagulopathy and
- •Patients with active urinary tract infections.
研究组 & 干预措施
Charateristcs of a multifunctional miniature nephroscope for percutaneous nephrolithotomy
Experimental
干预措施: percutaneous nephrolithotomy (Procedure)
结局指标
主要结局
Stone-free rate
时间窗: From enrollment to the end of treatment at 2 weeks
次要结局
未报告次要终点
研究者
Yongda Liu
Director of the Urology Department in First Affiliated Hospital of Guangzhou Medical University
The First Affiliated Hospital of Guangzhou Medical University
研究点 (1)
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