NCT00763711终止1 期
Injectable Bulking Agent Needle Guide
Carbon Medical Technologies4 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2008年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 17
- 试验地点
- 4
- 主要终点
- to evaluate the consistency of the location of the injection site and resulting location of bulking effect
研究概览
简要总结
The purpose of this study is to evaluate the use of the Needle Guide as an assist in properly guiding an injection needle into the appropriate tissue plane during an injectable bulking agent procedure in women using a FDA approved injectable bulking agent. The injectable bulking agent will be Durasphere EXP.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals satisfying the "Indications" and "Contraindications" criteria in the Durasphere EXP Directions for Use may participate.
排除标准
- 未提供
结局指标
主要结局
to evaluate the consistency of the location of the injection site and resulting location of bulking effect
时间窗: at procedure
Safety will be demonstrated through an analysis of morbidity and complication rates, (if any), associated with the use of the Needle Guide.
时间窗: 1 week
次要结局
- to evaluate the comparative ease of the injection procedure using the Bulking Agent Needle Guide as compared to the traditional transurethral or periurethral injection technique.(at procedure)
研究者
研究点 (4)
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