NCT04309383已完成不适用
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Pseudotumor Cerebri
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 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 pseudotumor cerebri.
详细描述
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 pseudotumor cerebri.
Flow may be limited due to slit ventricles
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old or older Adult men or women who possess a VP shunt placed for PTC;
- •Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent;
- •Subjects will be asymptomatic visiting for routine care at 2-4 weeks post op
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 VP 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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