NCT04011566招募中不适用
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Specificity of ShuntCheck test
研究概览
简要总结
The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with asymptomatic normal pressure hydrocephalus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Asymptomatic men or women 40 years old or older and have a ventriculoperitoneal shunt placed for normal pressure hydrocephalus and are visiting for routine care.
- •Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker capable of providing valid, signed informed consent.
排除标准
- •Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
- •ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
- •Presence of an interfering open wound or edema over any portion of the ventriculoperitoneal shunt.
结局指标
主要结局
Specificity of ShuntCheck test
时间窗: 15 minutes
Negative Predictive Value of ShuntCheck test
时间窗: 15 minutes
次要结局
- Negative Predictive Value of performing ShuntCheck test twice(60 minutes)
- Specificity of performing ShuntCheck test twice(60 minutes)
研究者
Naomi Abel
Assistant Professor, College of Medicine Neurosurgery
University of South Florida
研究点 (2)
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