NCT00721461已完成1 期
Probe Study of the Tolerability of an Investigational Electroporation Device, MedPulser (Trademark) DNA Delivery System (DDS) in Healthy Adults 18 to 35 Years of Age
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 主要终点
- Assess the tolerability of the MedPulser DDS device.
研究概览
简要总结
A study to evaluate the tolerability of electrostimulation applications with an investigational device known as the MedPulser DDS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be between the ages of 18 and 35
- •Woman who are able to become pregnant must use an acceptable form of birth control
排除标准
- •You are breast feeding
- •You have taken any type of pain reliever within 12 hours of electrostimulation
- •You have participated in another clinical study within 4 weeks of starting this study or plan to participate in another clinical study while participating in this study
- •You have muscle atrophy, weakness or neuromuscular disorder
研究组 & 干预措施
1
Experimental
V930
干预措施: V930 (Biological)
结局指标
主要结局
Assess the tolerability of the MedPulser DDS device.
时间窗: Severity of pain will be measured at time of treatment and 1, 5, 10, and 20 minutes and 24 hours after electrostimulation.
次要结局
未报告次要终点
研究者
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