Hydrocephalus Clinical Trial
Official title:
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
The purpose of this study is to compare the accuracy of ShuntCheck (SC) and ShuntCheck plus Micro-Pumper (SC+MP) to radionuclide shunt patency testing (SPS) in evaluating shunt function in patients with adult hydrocephalus (AH) implanted with ventriculoperitoneal (VP) shunts when shunt obstruction is suspected and a diagnostic procedure such as radionuclide shunt patency testing (SPS) is required.
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
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
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