Status:
UNKNOWN
Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus
Lead Sponsor:
University of South Florida
Collaborating Sponsors:
NeuroDx Development
Conditions:
Hydrocephalus, Normal Pressure
Eligibility:
All Genders
40+ years
Brief Summary
The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstru...
Detailed Description
The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstru...
Eligibility Criteria
Inclusion
- Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction.
- Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as "surrogates" in this protocol) capable of providing valid, signed informed consent
Exclusion
- Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction;
- ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated;
- Presence of an interfering open wound or edema over any portion of the VP shunt.
Key Trial Info
Start Date :
January 24 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04309487
Start Date
January 24 2020
End Date
January 1 2025
Last Update
June 1 2022
Active Locations (1)
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1
University of South Florida Department of Neurological Surgery and Brain Repair
Tampa, Florida, United States, 33606