ShuntCheck Versus Radionuclide in Evaluating Shunt Function in Symptomatic NPH Patients (SCNPH)
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.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
|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|
- Sensitivity and specificity of ShuntCheck vs SPS [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
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.
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Radionuclide SPS
Radionuclide Shunt Patency Study
Device: ShuntCheck test
Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing
Other Name: ShuntCheck
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01323764
|Contact: Michael A Williams, MD||(410) firstname.lastname@example.org|
|United States, Maryland|
|Sinai Hospital of Baltimore, LifeBridge Health||Recruiting|
|Baltimore, Maryland, United States, 21215|
|Contact: Michael A Williams, MD 410-601-1900 email@example.com|
|Principal Investigator: Michael A Williams, MD|
|Sub-Investigator: Robin K Wilson, MD, PhD|
|Sub-Investigator: Carol Wamboldt, CRNP|
|Principal Investigator:||Michael A Williams, MD||Sinai Hospital of Baltimore, LifeBridge Health|
|Study Chair:||Sherman C Stein, MD||NeuroDx Development|
|Study Director:||Marek Swoboda, PhD||NeuroDx Development|