NCT01862601已完成1 期
Study to Evaluate the Safety and Performance of the JetTouch Needle-Free Endoscopic Injection System to Deliver Saline Into the Bladder Wall of Healthy Subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Safety of the JetTouch system to deliver saline into the bladder wall.
研究概览
简要总结
This research study is being done to see how well the JetTouch Needle-Free Endoscopic Injection System is able to deliver a solution safely into the bladder wall. The JetTouch Needle-Free Endoscopic Injection System is a jet injector that allows fluids to be injected into the bladder without using a needle. It is hoped that this method will provide a reliable and consistent method to deliver drugs into the bladder wall.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy individuals (male and female) aged 18-55 without urinary complaints or documented urinary tract dysfunctions.
排除标准
- •Unable or unwilling to sign Informed Consent Form or comply with study requirements
- •Non-English speaking
- •Currently enrolled in another clinical trial
- •Undergone treatments given into the bladder in the past 4 weeks
- •Female subject and has a positive urine pregnancy test at the time of screening/procedure or intends to become pregnant while enrolled
- •Female subject and is currently breast feeding
- •Female subject and has given birth in past 6 months
- •Current or history of chronic urinary tract infections
- •Current or history of chronic hematuria
- •Current or history of bladder cancer
- •History of major surgery in the last 6 months
- •Current or history of bleeding disorders
- •Currently taking anticoagulants
- •Taking aspirin and is unable to discontinue treatment for 2 weeks prior to bladder injection
- •Taking NSAIDS and is unable to discontinue 48 hours prior to bladder injection
- •Platelet count, prothrombin time/INR (PT/INR) and partial thromboplastin time (PTT) outside the normal limits of the laboratories established reference ranges
- •Current or history of any of the following: neurogenic bladder, radiation to pelvic area, inflammation of the bladder wall because of tuberculosis, schistosomiasis, bladder or ureteric calculi
- •Known hypersensitivity to any of the agents used in the injection (FLEXLINE-Bladder® Attachment material, lidocaine, saline, Indigo Carmine dye or Ciprofloxacin)
- •Current or history of any medical condition that in the opinion of the Investigator would make them an unsuitable candidate for this study.
结局指标
主要结局
Safety of the JetTouch system to deliver saline into the bladder wall.
时间窗: within 14 days of the JetTouch procedure
Ability of the JetTouch system to deliver saline into the bladder wall.
时间窗: At the JetTouch procedure
次要结局
- Subject feedback question regarding the procedure.(At the JetTouch procedure)
- Physician feedback on the use of the JetTouch system.(At the JetTouch Procedure)
- Physician feedback on perceived subject tolerability of the JetTouch injection procedure.(At the JetTouch procedure.)
研究者
研究点 (3)
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