Status:
WITHDRAWN
ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients
Lead Sponsor:
NeuroDx Development
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Normal Pressure Hydrocephalus
Eligibility:
All Genders
35-90 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to examine the role of ShuntCheck and MR Imaging in evaluating the presence or absence of Shunt Obstruction in the patients of Hydrocephalus or Idiopathic Intracranial Hyp...
Detailed Description
This study aims to correlate findings of ShuntCheck and MRI with the Radionuclide patency study. Patients will be enrolled if they have Hydrocephalus or IIH, present with symptoms of shunt obstruction...
Eligibility Criteria
Inclusion
- Adult Patients \> 35 years capable and willing to consent for their participation or consent obtained from a legal guardian.
- Patients with an indwelling shunt and clinical assessment strongly suggestive of shunt obstruction
- Patients are candidates for shunt patency procedures in the elective extension
Exclusion
- Patients \<35 years of age
- Patients with symptoms attributable to valve malfunction or shunt infection
- Patients who need urgent shunt replacement and therefore cannot wait for the SHUNTCHECK evaluation of shunt patency.
- Patients with edema or wound of skin overlying the shunt tissue.
- Patients not capable or not willing to consent to participate in the study
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00793416
Start Date
November 1 2008
End Date
August 1 2012
Last Update
October 29 2013
Active Locations (1)
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1
Johns Hopkins Medical Center
Baltimore, Maryland, United States, 21287