A Randomized, Controlled, Prospective, Single Blind Clinical Evaluation of BackStop in Patients Undergoing Intraureteric Stone Lithotripsy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no".
研究概览
简要总结
The purpose of this clinical study is to evaluate BackStop, a polymer-based device that is intended to be used during ureteroscopic lithotripsy to prevent retrograde stone migration. It is a water soluble polymer with reverse thermosensitive properties; the polymer exists as a liquid at low temperature (below 17 C) and rapidly transitions to a high viscosity gel at body temperature (i.e. in the ureter). BackStop is injected above the stones in the ureter and is intended to prevent retrograde migration of stones during ureteroscopic lithotripsy. Upon completion of the lithotripsy procedure, BackStop dissolves naturally or by irrigation.
The study hypothesis is that a greater proportion of patients will experience no retropulsion of a kidney stone when BackStop is used versus no anti-retropulsion device when undergoing intracorporeal lithotripsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Patient with a solitary, radio-opaque ureteral stone in the proximal ureter.
- •Clinical indication for treatment by ureteroscopic lithotripsy.
- •Minimum 18 years old (or any institutional age limits for participation in clinical study).
- •Patients must be willing and able to participate in any follow-up visits, as required.
- •Patients must provide informed consent.
排除标准
- 未提供
研究组 & 干预措施
BackStop
Intracorporeal lithotripsy with the use of an anti-retropulsion device.
干预措施: BackStop (Device)
Control
No anti-retropulsion device will be used during lithotripsy.
干预措施: Intracorporeal lithotripsy without the use of an anti-retropulsion device (Device)
结局指标
主要结局
Ability of BackStop™ to minimize migration stone fragments in the proximal ureter will and reported as "yes" or "no".
时间窗: intra-operative
次要结局
- Extent of residual fragments remaining in ureter at the follow-up visit 2 to 4 weeks post-procedure.(one month)
- In the event that stone fragments migrate retrograde, there may be a need for the physician to employ additional procedures(one month)