ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients (SCNPH)
A Double- Blinded Comparison of the Accuracy of ShuntCheck, a Non-Invasive Device, to Radionuclide Shunt Patency Test in Evaluating Shunt Function in Patients With Adult Hydrocephalus With Possible Shunt Obstruction
研究概览
详细说明
The primary objective is to demonstrate that the accuracy of SC and SC+MP for determining whether a VP shunt is patent or obstructed is statistically no different than the accuracy of the accepted standard test, radionuclide shunt patency study, when performed simultaneously.
A secondary objective is to determine SC and SC+MP results in the presence of possible partial obstruction, which defined as subjects with radionuclide clearance measured by T1/2 of 8 to 10 minutes.
A secondary objective is to compare ShuntCheck flow rate results to simultaneous radionuclide clearance as measured by T1/2. A secondary objective is to demonstrate that ShuntCheck flow rate results are statistically equivalent to simultaneous radionuclide clearance measured by T1/2
研究类型
注册 (预期的)
阶段
- 第四阶段
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21215
- Sinai Hospital of Baltimore, LifeBridge Health
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adult men or women > 35 years of age;
- 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;
- Possess a shunt placed for AH;
- A radionuclide shunt patency study has been ordered because of suspected shunt obstruction
- Subject is willing and able to return to the treating physician for evaluation of the outcome of the shunt patency study
Exclusion Criteria:
- 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;
- Subject is unwilling or unable to return to the treating physician for the SPS and ShuntCheck testing.
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Radionuclide SPS
Radionuclide Shunt Patency Study
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Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Sensitivity and specificity of ShuntCheck vs SPS
大体时间：Day 1
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The primary efficacy objective is the sensitivity and specificity of the ShuntCheck test. The performance of ShuntCheck test will be compared to the radionuclide scanning done on the day of ShuntCheck administration. Primary efficacy of the SC and SC+MP test will be determined by comparing SC and SC+MP performance to results of radionuclide scanning according to a standard 2 x 2 table, with a Positive test result defined as evidence of shunt obstruction. |
Day 1
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合作者和调查者
调查人员
- 首席研究员：Michael A Williams, MD、Sinai Hospital of Baltimore, LifeBridge Health
- 学习椅：Sherman C Stein, MD、NeuroDx Development
- 研究主任：Marek Swoboda, PhD、NeuroDx Development
出版物和有用的链接
有用的网址
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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