A Double-Blinded Comparison of the Accuracy of ShuntCheck, a Non-Invasive Device

非侵入性设备 ShuntCheck 准确性的双盲比较

• 批准号: 8057207
• 负责人: Marek Swoboda
• 金额: $ 21万
• 依托单位: NEURODX DEVELOPMENT, LLC
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-01 至 2015-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8057207
• 关键词: Abbreviations; Abdomen; Accident and Emergency department; Address; Adult; Algorithms; Animal Model; Biomedical Engineering; Blinded; Brain; Cerebral Ventricles; Cerebrospinal Fluid; Cerebrospinal fluid shunts procedure; Characteristics; Clinic; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Computer software; Creation of ventriculo-peritoneal shunt; Data; Dementia; Detection; Development; Devices; Diagnosis; Diagnostic; Diagnostic Sensitivity; Diagnostic Specificity; Disease; Double-Blind Method; Drops; Early Diagnosis; Enrollment; Failure; Gait; Goals; Gold; Hand; Hospitals; Housing; Hydrocephalus; Image; Impairment; Infection; Injection of therapeutic agent; Label; Liquid substance; Measurement; Measures; Methods; Monitor; Movement; Neurosurgeon; Normal Pressure Hydrocephalus; Obstruction; Outcome; Outcome Study; Outpatients; Pathway interactions; Patients; Performance; Peritoneal; Phase; Pilot Projects; Positioning Attribute; Printing; Procedures; Process; Radioisotopes; Radionuclide Imaging; Relative (related person); Risk; Savings; Schedule; Screening Result; Sensitivity and Specificity; Serious Adverse Event; Shunt Device; Skin Temperature; Small Business Innovation Research Grant; Specificity; Symptoms; Syndrome; Techniques; Temperature; Test Result; Testing; Time; Translating; Urinary Incontinence; Validation; Work; X-Ray Computed Tomography; base; blind; design; diagnostic accuracy; experience; fluid flow; human study; improved; micturition urgency; pressure; prospective; standard of care; subcutaneous; tool; validation studies

DESCRIPTION (provided by applicant): This Phase 1 SBIR will develop a non-invasive alternative to radionuclide shunt patency testing for evaluating Normal Pressure Hydrocephalus (NPH) patients with suspected shunt malfunction. Hydrocephalus is a disorder of cerebrospinal fluid dynamics that is commonly treated by placing a shunt that carries excess fluid from the brain to the abdomen. While this treatment is generally successful, shunts inevitably fail, usually by obstruction. The clinical signs of shunt obstruction, the gradual decline into dementia-like symptoms, make shunt failure challenging to diagnose. Suspected obstruction in NPH patients is typically investigated using an invasive radionuclide shunt patency study. There are currently no non-invasive, non- radiological techniques for the early diagnosis of shunt obstruction. NeuroDx Development (NeuroDx) is developing a tool, ShuntCheck, for rapid, non-invasive measurement of CSF flow through a VP shunt by transcutaneous temperature detection as cooled CSF moves through the shunt tubing. The resulting hand-held device is a convenient method for rapidly determining shunt function. Key to translating this device into the NPH clinic is the completion of a clinical validation study to compare the device's diagnostic sensitivity and specificity to radionuclide testing. The goal of this Phase 1 project is to complete a 25 patient clinical study of ShuntCheck compared to radionuclide. In Phase 2, we anticipate conducting a multi-center outcomes study of ShuntCheck as a shunt patency test for NPH patients. This study will be conducted as a pivotal trial and will be used to support expanded labeling for ShuntCheck. The result of this study could be an important change in the diagnostic algorithm currently used to manage symptomatic NPH 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 product 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 supporting a clinical study comparing the accuracy of a non-invasive device, ShuntCheck, to the current invasive gold standard, radionuclide testing, in diagnosing shunt malfunction in adult normal pressure hydrocephalus (NPH) patients. The results of this study could support an important change in the standard diagnostic pathway currently used to manage symptomatic NPH patients.

描述（由申请人提供）：该1期SBIR将开发一种非侵入性替代放射性核素分流管通畅试验，用于评估怀疑分流管功能障碍的常压脑积水（NPH）患者。脑积水是一种脑脊液动力学紊乱，通常通过放置分流器将多余的液体从大脑输送到腹部来治疗。虽然这种治疗通常是成功的，但分流不可避免地会失败，通常是由于阻塞。分流管阻塞的临床症状，逐渐下降到痴呆样症状，使得分流管衰竭难以诊断。NPH患者疑似梗阻通常采用侵入性放射性核素分流术进行通畅研究。目前还没有无创的、非放射的技术来早期诊断分流梗阻。NeuroDx Development （NeuroDx）正在开发一种名为ShuntCheck的工具，该工具可以在冷却后的脑脊液通过分流管移动时，通过经皮温度检测，快速、无创地测量脑脊液通过VP分流管的流量。由此产生的手持装置是一种快速确定分流功能的方便方法。将该设备转化为NPH临床的关键是完成临床验证研究，将该设备的诊断敏感性和特异性与放射性核素测试进行比较。这个一期项目的目标是完成一项25例患者的临床研究，将ShuntCheck与放射性核素进行比较。在第二阶段，我们预计将对ShuntCheck进行多中心结果研究，作为NPH患者的分流通畅测试。该研究将作为关键试验进行，并将用于支持ShuntCheck的扩展标签。这项研究的结果可能是目前用于治疗有症状的NPH患者的诊断算法的一个重要改变。考虑到需要一种非侵入性方法来准确诊断分流失败，与其他方法相比，潜在的节省和改善患者预后的潜力，这项研究的数据将支持一种具有商业可行性和极其重要的产品。