A Comparative Study of Performance and Cost-effectiveness of Three Different Single-Use Flexible Ureteroscopes in the Management of Renal Stones: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Cost-effectiveness of single-use flexible ureteroscopes
研究概览
简要总结
The current study aims to compare the performance of three distinct single-use digital flexible ureteroscope types in terms of cost-effectiveness, postoperative complications, operating time, and stone-free rates (SFRs).
详细描述
Retrograde intrarenal surgery (RIRS) is the preferred treatment modality for renal stones measuring less than 20 millimeters (mm). Several types of flexible ureteroscopes are currently available on the market from different manufacturers. However, there is a shortage of comparative studies evaluating the performance of different single-use flexible ureteroscopes.
This study aims to compare the performance of three different single-use digital flexible ureteroscopes in terms of cost-effectiveness, postoperative complications, operative time, and stone-free rates (SFRs).
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 60 years.
- •Presence of renal stones measuring less than 20 millimeters (mm).
排除标准
- •Renal stones larger than 20 millimeters (mm).
- •Uncontrolled bleeding disorders or coagulopathies.
- •Active urinary tract infection.
- •Renal failure.
- •Uncontrolled diabetes mellitus, hypertension, or hepatic dysfunction.
- •Pregnancy.
- •Abnormal urinary tract anatomy or known ureteric stricture.
- •History of previous open ureteric surgery.
研究组 & 干预措施
LithoVue™ (Boston Scientific Corporation)
Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the LithoVue™ single-use digital flexible ureteroscope.
干预措施: LithoVue™ (Boston Scientific Corporation) (Device)
WiScope® (OTU Medical Inc. (Silicon Valley, USA))
Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the WiScope® single-use digital flexible ureteroscope.
干预措施: WiScope® (OTU Medical Inc. (Silicon Valley, USA)) (Device)
Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.)
Participants randomized to this arm will undergo retrograde intrarenal surgery (RIRS) for renal stone management using the single-use digital flexible ureterorenoscope manufactured by Scivita Medical Technology Co., Ltd.
干预措施: Single-Use Ureterorenoscope (Scivita Medical Technology Co., Ltd.) (Device)
结局指标
主要结局
Cost-effectiveness of single-use flexible ureteroscopes
时间窗: 4 weeks postoperatively
Comparison of total procedural cost and stone-free rate among three single-use flexible ureteroscopes used in retrograde intrarenal surgery (RIRS).
次要结局
- Operative Time and Postoperative Complications(up to 4 weeks postoperatively)
研究者
Hesham Elsayed Mohammed
Principal Investigator
Ain Shams University