NCT03339388终止不适用
Multi-Center Feasibility Study of Enhanced Lithotripsy System (ELS) in The Treatment of Urinary Stone Disease
Avvio Medical8 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2017年12月8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
- 13
- 试验地点
- 8
- 主要终点
- Proportion of study participants with Serious Device and/or Serious Procedure-Related Adverse Events (Safety)
研究概览
简要总结
This is a single arm, multi-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, multi-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 90 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥ 18 years to ≤ 75 years.
- •One urinary stone-apparent on a computed tomography (CT) scan within 14 days prior to study enrollment
- •Stone size, as estimated by pre-procedure CT, with all dimensions 15 mm or less.
- •Provides written informed consent
- •Understands and accepts the study requirements
排除标准
- •Age less than 18 years of age or over 75 years of age
- •Diagnosis of radiolucent stones
- •Diagnosis of stones in the lower pole of kidney
- •History of cystinuria
- •Urine pH below 5.5
- •Current untreated urinary tract infection
- •Pregnancy
- •Coagulation abnormality or taking prescription anticoagulants. Aspirin usage will be discontinued at least 7 days prior to enrollment at the discretion of the attending physician.
- •Mobility issues - unable to comfortably lie still for up to 30 minutes or unable to roll from back to side
- •Known hypersensitivity to conductivity gel
- •Vulnerable individuals (mentally disabled, physically disabled, prisoner, etc.)
- •Body mass index greater than 35
- •American Society of Anesthesiologists (ASA) score of 3 or greater general anesthesia risk level
- •Known sensitivity to possible medications used before, during, or after the ELS procedure, including but not limited to the following: sedative agents, general anaesthetics, topical anaesthetics, and opioid analgesics.
- •Enrollment in another research study or previous participation within 30 days of enrollment.
结局指标
主要结局
Proportion of study participants with Serious Device and/or Serious Procedure-Related Adverse Events (Safety)
时间窗: 90 days
Incidence of Serious Device and/or Serious Procedure-Related adverse events
次要结局
- Stone-free status(30 days)
研究者
研究点 (8)
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