NCT03195920终止不适用
Feasibility Study of an Enhanced Lithotripsy System in the Treatment of Urinary Stone Disease
Avvio Medical2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2017年7月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Proportion of subjects with serious device-related adverse events (safety)
研究概览
简要总结
This is a single arm, single center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones.
详细描述
This is a single arm, single center study to assess the safety and efficacy of a form of extracorporeal lithotripsy, called the Enhanced Lithotripsy System, to treat urinary stones. Subjects will be treated up to 2 times with the Enhanced Lithotripsy System and followed for 30 days after the last treatment session.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals presenting with one urinary stone-apparent on a computed tomography scan within the last 14 days
- •Males and females aged 18 or older
- •Capable of giving informed consent, and willing to have the informed consent process videotaped
- •Stone size, as estimated by pre-operative computed tomography, with all dimensions 15 mm or less.
排除标准
- •Individuals under 18 years of age
- •Individuals with radiolucent stones
- •Individuals with stones in the lower pole of kidney
- •Individuals not following up in the treating hospital
- •Individuals with history of cystinuria
- •Individuals with urine pH below 5.5
- •Individuals with untreated urinary tract infection
- •Individuals who are not willing to use adequate method of contraception during the study period
- •Women who are pregnant, lactating or planning pregnancy during the study period
- •Individuals with a coagulation abnormality or taking prescription anticoagulants.
- •Individuals with mobility issues who are unable to comfortably lie still for up to 30 minutes or roll from their back to their side
- •Individuals belonging to a vulnerable group (pregnant, mentally disabled, physically disabled, prisoner, etc.)
- •Individuals with a body mass index greater than 35
- •Individuals with ASA score of 3 or greater general anesthesia risk level
- •Known sensitivity to possible medications used before, during, or after the treatment procedure, including but not limited to the following: sedative agents, general anesthetics, topical anesthetics, and opioid analgesics
结局指标
主要结局
Proportion of subjects with serious device-related adverse events (safety)
时间窗: 30 days after last treatment session
Safety: Proportion of subjects with serious device-related adverse events
次要结局
- Successful treatment of urinary stone(14 days after last treatment session)
研究者
研究点 (2)
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