ShuntCheck Clinical Validation and ShuntCheck-Micro-Pumper Assessment of CSF Shun

ShuntCheck 临床验证和 ShuntCheck-微泵评估 CSF Shun

• 批准号: 8071595
• 负责人: Marek Swoboda
• 金额: $ 35万
• 依托单位: NEURODX DEVELOPMENT, LLC
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-05-11 至 2013-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8071595
• 关键词: Address; Algorithms; Biosensor; Boston; Brain Death; Brain Injuries; Brain imaging; Cardiac; Cerebral Ventricles; Cerebrospinal Fluid; Cerebrospinal fluid shunts procedure; Child; Childhood; Clinical; Collaborations; Communities; Complication; Data; Development; Device or Instrument Development; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostic Specificity; Exposure to; Failure; Fright; Goals; Headache; Hospitals; Hydrocephalus; Image; Imaging Techniques; Individual; Infection; Investigation; Label; Legal patent; Life; Liquid substance; MRI Scans; Magnetic Resonance Imaging; Marketing; Measures; Medical Device; Methods; Modality; Nature; Nausea; Notification; Obstruction; Operative Surgical Procedures; Outcome; Outpatients; Patients; Pediatric Hospitals; Performance; Phase; Physiologic pulse; Pilot Projects; Procedures; Program Development; Pump; Radiation; Radioisotopes; Reading; Research; Research Design; Risk; Safety; Sample Size; Savings; Shunt Device; Skin Temperature; Small Business Innovation Research Grant; Specificity; Symptoms; Techniques; Technology; Temperature; Testing; Time; Uncertainty; Validation; Work; X-Ray Computed Tomography; base; cerebrospinal fluid flow; clinical decision-making; experience; fluid flow; improved; innovation; mathematical algorithm; meetings; operation; public health relevance; repaired; research clinical testing; tool; vibration

DESCRIPTION (provided by applicant): The goal of this SBIR is to create the first comprehensive set of clinical tools and noninvasive methods for diagnosing cerebrospinal fluid (CSF) shunt obstruction and to validate them to convince clinicians of their clinical value. Hydrocephalus is a common condition in which CSF accumulates in the brain ventricles, potentially leading to brain damage and death. It is corrected by placing a VP shunt that carries excess CSF away. Although enormously successful, shunts eventually fail, usually by obstruction. However, the clinical symptoms of shunt obstruction, primarily including headache and nausea, are non-specific, making shunt failure challenging to diagnose. Suspected obstruction is typically investigated using static MRI and CT scans which are expensive, and require evidence of fluid accumulation in serial images, precluding prediction of shunt failure. Exposure to radiation is also significant in shunted children, who may require several shunt investigations annually. Radionuclide studies, which provide dynamic measures of shunt CSF flow, are invasive and carry the risk of infection. They also have reduced diagnostic specificity due to intermittent shunt flow - patent shunts do not flow continuously leading to a high level of false positive readings. A new, non- invasive test for shunt flow, ShuntCheck, also suffers from reduced specificity due to intermittent shunt flow, leading to questions about the device's accuracy. There are currently no tools for differentiating between intermittently flowing patent shunts and occluded shunts. NeuroDx Development (NeuroDx) has recently developed and bench tested "Micro-Pumper", a small device which is held against the shunt valve during the ShuntCheck test. The device provides specific vibration pulses to the valve, creating a controlled level of CSF flow through the valve. We have shown that the Micro-Pumper, used in combination with ShuntCheck can differentiate between non-flowing patent shunts and occluded or partially occluded shunts. The goal of this Phase 1 project is to validate the accuracy of the ShuntCheck flow/no-flow determination via comparison to MRI flow testing and to test the Micro-Pumper/ShuntCheck combination in a pilot study or pediatric hydrocephalus patients at Children's Hospital Boston. By the end of Phase 2, we anticipate having accumulated sufficient data to enable submission of a pre-market notification (510(k)) to the FDA for the Micro- Pumper (in conjunction with ShuntCheck). The result of this work will be an important change in the diagnostic algorithm currently used to manage hydrocephalus patients. Given the need for a non-invasive method to accurately diagnose shunt failure, the potential savings over alternative methods and the potential for improved patient outcomes, the data from this study will support a diagnostic procedure which is commercially viable and extremely important. PUBLIC HEALTH RELEVANCE: This proposal addresses the need for diagnostic tools for use in a hospital or outpatient setting that work in real-time to quantitatively determine shunt function by creating the first comprehensive set of clinical tools and noninvasive methods for diagnosing cerebrospinal fluid (CSF) shunt obstruction and validating them to convince clinicians of the valuable information available from ShuntCheck(R) (SC) and Micro-Pumper. Obstruction of CSF shunts, a common complication, is currently diagnosed by radiation imaging techniques, such as CT Scan, or by invasive procedures, such as shunt tapping. These new tools will enable shunt obstruction to be diagnosed and will provide a research tool for understanding shunt function.

描述（由申请人提供）： 该SBIR的目的是创建第一组综合的临床工具和无创方法，用于诊断脑脊液（CSF）分流阻塞，并验证他们使临床医生对其临床价值说服。脑积水是CSF在脑室中积聚的常见疾病，可能导致脑损伤和死亡。通过放置将多余CSF携带的VP分流器纠正。尽管取得了巨大成功，但分流器最终通常会因障碍物而失败。然而，分流阻塞的临床症状，主要包括头痛和恶心，是非特异性的，使分流失败挑战诊断。通常，使用静态MRI和CT扫描来研究可疑的障碍，这些静态MRI和CT扫描需要串行图像中流体积累的证据，从而排除了分流故障的预测。流失的儿童也可能需要每年进行几次分流调查。放射性核素研究提供了分流CSF流动的动态度量，具有侵入性，并承受感染的风险。由于间歇性分流的流动，它们还降低了诊断特异性 - 专利并不会连续流动导致高水平的假阳性读数。对分流流的新的，非侵入性的测试，shuntcheck也因间歇性分流流而导致的特异性降低，导致有关设备准确性的疑问。当前，没有任何工具可区分间歇性流动的专利分流和遮挡分流。 NeuroDX开发（NeuroDX）最近开发并测试了“微型驾驶员”，这是一种小型设备，在洪图检查期间针对分流阀持有。该设备为阀门提供了特定的振动脉冲，从而形成了通过阀门的控制水平的CSF流量。我们已经表明，与平底Check结合使用的微型驾驶器可以区分非流动的专利分流器和遮挡或部分遮挡的分流。该第1阶段项目的目的是通过比较MRI流量测试来验证Shuntcheck流量/无流量测定的准确性，并在一项试验性研究或儿童医院医院患者的PILOT研究或小儿脑积水患者中测试微型Pumper/Shuntcheck组合。到第2阶段结束时，我们预计已经积累了足够的数据，以使Micro-Pumper的FDA提交前市场通知（510（k））（与Shuntcheck结合使用）。这项工作的结果将是目前用于管理脑积水患者的诊断算法的重要变化。考虑到需要一种非侵入性方法来准确诊断分流故障，对替代方法的潜在节省以及改善患者预后的潜力，这项研究的数据将支持一种诊断程序，该程序在商业上可行且极为重要。 公共卫生相关性： 该建议解决了实时使用的诊断工具，以实时工作，以定量确定分流功能，通过创建第一组全面的临床工具和无创方法，用于诊断脑脊液（CSF）分流器障碍物（CSF）分流阻塞，并确保临床医生可从Shunteckeck（Scroce）（Roc）（roc）（roc）（roc）（roc）（roc）（roc）（roc）（roc）。 CSF分流器的阻塞是一种常见的并发症，目前是通过辐射成像技术（例如CT扫描）或通过侵入性手术（例如分流式攻击）诊断的。这些新工具将使分流障碍物被诊断出，并将为理解分流功能提供研究工具。