The Impact of Ureteral Access Sheath Design on Ease of Placement and Ureteral Wall Injury During Flexible Ureteroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 主要终点
- Number of Participants With Successful Sheath Placement
研究概览
简要总结
The purpose of this study is to assess whether one of two ureteral access sheaths is safer for patients undergoing ureteroscopy. Both sheaths are FDA approved devices and commercially available. The investigators will compare the ability of sheaths to access the kidney through the ureter and will compare damage done to the ureter after completion of the procedure. Access sheaths are standard of care for this procedure; this study seeks to optimize outcomes for patients.
Patients undergoing ureteroscopy who do not have ureteral stents in place and who have not had an ipsilateral procedure within 90 days will be recruited and consented.
详细描述
The purpose of this study is to compare two ureteral access sheaths in how the sheaths damage the ureter during flexible ureteroscopy.
Condition Intervention Kidney Stones Nephrolithiasis Urolithiasis Device: Cook Flexor or Boston Scientific Navigator HD
Study Type: Interventional Study Design: Intervention Model: Two group randomized assignment Masking: Single blind Primary Purpose: Treatment
Primary Outcome Measures:
• Successful placement of sheath (yes or no).
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
- Single (Care Provider)
盲法说明
Videos will be analyzed by blinded urologists who will rate the extent of ureteral damage on a standardized scale of 0 to 4 according to the study published by Traxer et al. 2013. After the study, subjects will not be contacted.
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
- •Patients planned for ureteroscopy
- •Current CT scan within 90-days before the operation
- •Able to give informed consent
- •Ages 18 years and older
排除标准
- •Inability to give informed consent
- •Age less than 18 years
- •Stones in the ureter
- •Having previous ipsilateral ureteral or renal surgery within 90 days
- •Having stents placed in ipsilateral ureter within 90 days
研究组 & 干预措施
Cook Flexor
ureteral access sheath
干预措施: Cook Flexor (Device)
Boston Scientific Navigator HD
ureteral access sheath
干预措施: Boston Scientific Navigator (Device)
结局指标
主要结局
Number of Participants With Successful Sheath Placement
时间窗: One time point - at the beginning of the procedure
The surgeon documents whether there was Successful placement of sheath (yes or no)
次要结局
- Ease of Sheath Placement(One time point - at the completion of the procedure)
- Number of Participants With Injury to the Ureter(One time point - at the completion of the procedure)
研究者
Manoj Monga, MD
Director of Endourology and Stone Disease
The Cleveland Clinic