NCT01885468已完成不适用
X-Ray Verified Accuracy of the Aesculap - Miethke proGAV Adjustable Shunt Pressure Setting Verification Instrument
Aesculap, Inc.2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2013年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Level of agreement between the proGAV® verification instrument measurement and X-ray control measurements.
研究概览
简要总结
This study is to verify the use of a hand held tool to verify the new setting of a hydrocephalus shunt (proGAV). This tool would be used in place of an Xray of the patient's head, which is how settings are verified currently.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Implanted with proGAV Requiring adjustment Implant must be palpable under the skin
排除标准
- •Unwilling to consent Implanted within 7 days of inclusion visit
结局指标
主要结局
Level of agreement between the proGAV® verification instrument measurement and X-ray control measurements.
时间窗: 1day
次要结局
未报告次要终点
研究者
研究点 (2)
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