NCT04309487招募中不适用
Diagnostic Accuracy of ShuntCheck Compared With Radionuclide Shunt Patency Test to Detect Shunt Flow Obstruction in Patients With Normal Pressure Hydrocephalus - A Cross-sectional Analytic Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study
研究概览
简要总结
The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.
详细描述
The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction.
- •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
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
Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study
时间窗: 60 Minutes
Sensitivity of ShuntCheck compared to radionuclide shunt patency study
时间窗: 15 minutes
次要结局
未报告次要终点
研究者
Naomi Abel
Assistant Professor, College of Medicine Neurosurgery
University of South Florida
研究点 (2)
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