Normal Pressure Hydrocephalus Clinical Trial
Official title:
Accuracy of ShuntCheck and MRI in Detection of Shunt Obstruction in Patients Receiving Shunt Patency Test
Verified date | October 2013 |
Source | NeuroDx Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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 Hypertension (IIH) undergoing radionuclide test for suspected shunt obstruction. This is an exploratory study to determine how a non-invasive device can assist in detection of presence of flow in these patients.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 2012 |
Est. primary completion date | August 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 35 Years to 90 Years |
Eligibility |
Inclusion Criteria: 1. Adult Patients > 35 years capable and willing to consent for their participation or consent obtained from a legal guardian. 2. Patients with an indwelling shunt and clinical assessment strongly suggestive of shunt obstruction 3. Patients are candidates for shunt patency procedures in the elective extension Exclusion Criteria: 1. Patients <35 years of age 2. Patients with symptoms attributable to valve malfunction or shunt infection 3. Patients who need urgent shunt replacement and therefore cannot wait for the SHUNTCHECK evaluation of shunt patency. 4. Patients with edema or wound of skin overlying the shunt tissue. 5. Patients not capable or not willing to consent to participate in the study |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins Medical Center | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
NeuroDx Development | Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction | Pre and post shunt revision surgery | No | |
Secondary | To assess any adverse events that arise from conducting ShuntCheck test To assess the cost effectiveness of ShuntCheck screening upon completion of the study | Pre and post shunt revision surgery | Yes |
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