FlexStone Enabled Kidney Stone Retrieval
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Successful retrieval of kidney stones
研究概览
简要总结
This study investigates if additional basket control in helpful during retrieval of kidney stones especially those that are difficult to reach for standard baskets.
详细描述
The clinical practice at Vanderbilt University Medical Center will perform standard flexible ureteroscopy (fURS) procedures using conventional stone retrieval baskets, the EndoTheia FlexStone basket, laser fibers for intracorporeal lithotripsy , and any other fURS accessory devices as determined by the surgeon. If renal calculi are present which the physician deems retrieval of would benefit from the added aimability of the EndoTheia FlexStone basket will be used.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 to 80 years of age
- •Able to provide written informed consent
- •Have renal stones present and are appropriate candidates for fURS
排除标准
- •Females who are pregnant. As part of routine pre-operative care, all females of childbearing potential will undergo either urine or blood pregnancy testing.
- •Cancer positive subjects or any patients currently undergoing any treatment or therapy to treat, cure, or mitigate cancer.
- •Patients with active urinary tract infection or anatomy that complicates retrograde access to the ureter and kidney
- •Patients who do not meet inclusion criteria
- •Patients who are unable or unwilling to provide informed consent
研究组 & 干预措施
Kidney Stone Retrieval
All patients in this group will have the EndoTheia FlexStone basket used to assist in the retrieval of kidney stones
干预措施: Kidney Stone Retrieval (Device)
结局指标
主要结局
Successful retrieval of kidney stones
时间窗: Day 1 Post-Intervention
The primary end point of this feasibility study is to demonstrate that the additional basket aimability of the device enables basket to capture stones in difficult to reach locations such as the lower pole.
次要结局
未报告次要终点