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

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$210,038.00
Award Year:
2011
Program:
SBIR
Phase:
Phase I
Contract:
1R43NS067770-01A1
Award Id:
n/a
Agency Tracking Number:
R43NS067770
Solicitation Year:
2011
Solicitation Topic Code:
NINDS
Solicitation Number:
PA09-206
Small Business Information
3333 Street Road, SUITE 210, Bensalem, PA, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
828682240
Principal Investigator:
MAREK SWOBODA
(215) 645-1280
dr.marekswoboda@gmail.com
Business Contact:
FREDERICK FRITX
(609) 865-4426
ffritz@neurodx.com
Research Institute:
Stub




Abstract
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 cooledCSF 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 tomanage 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 productwhich 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.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government