NCT00583336Unknown不适用
Physician Preference Study of the Utility of ShuntCheck to Detect Cerebrospinal Fluid (CSF) in Patients With Ventriculo-Peritoneal CSF Shunts
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested
研究概览
简要总结
ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction.
Secondarily, the ShuntCheck test will yield the clearest results when patients are tested sitting up (or alternatively while supine)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be 0 - 85 years of age, of any race or sex with parent consent for minors
- •Subjects must have a chronically indwelling ventriculo-peritoneal shunt that is palpable along the clavicle.
- •Subjects must be physically stable as determined by the physician.
排除标准
- •Subjects with the presence of an open wound at the shunt site that could interfere with the collection of ShuntCheck data.
- •Subjects unable to lie supine with head elevated 30 degrees or less
- •Subjects who have had shunt surgery within two weeks.
- •Inability or unwillingness of subject to endure the test.
- •Other judgments of the investigator.
结局指标
主要结局
ShuntCheck result of "Flow Confirmed" for asymptomatic shunted patients tested
时间窗: Tested in single visit
次要结局
- ShuntCheck result of "Flow Not Confirmed" for symptomatic shunted patients with shunt obstruction(Single visit)
研究者
研究点 (2)
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