- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00793416
ShuntCheck Accuracy in Detecting Shunt Obstruction Normal Pressure Hydrocephalus (NPH) Patients
Accuracy of ShuntCheck and MRI in Detection of Shunt Obstruction in Patients Receiving Shunt Patency Test
Study Overview
Status
Conditions
Intervention / Treatment
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 and will need to undergo shunt patency test and an MRI along with standard of care radionuclide study. The ShuntCheck study will be conducted in a clinic, doctor's office or in an emergency room by the treating physician or by trained health care professionals.
Also, patients who are found with shunt obstruction as diagnosed by Radionuclide study will undergo shunt revision and the findings of the study will be correlated with operative findings. Post Shunt replacement patients who also receive adjustable valve will be evaluated with shunt Check, before and after adjustment of valves to detect changes in flow as detected by shunt check.
This is an exploratory study to determine how a non-invasive device can assist in detection of presence of flow in these patients.
Approximately 20 subjects will be enrolled in a single site in this proof of concept, physician sponsored study. An approved, commercial device will be available to the site prior to start of the study.
Study Type
Phase
- Phase 4
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ShuntCheck measure
All patients will have ShuntCheck measurements along with radionuclide shunt patency testing.
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Shunt flow detection based upon ShuntCheck results compared to radionuclide test results
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exploratory Evaluation of the Utility of ShuntCheck in detection of ShuntFlow in patients admitted with potential shunt obstruction
Time Frame: Pre and post shunt revision surgery
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Pre and post shunt revision surgery
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To assess any adverse events that arise from conducting ShuntCheck test To assess the cost effectiveness of ShuntCheck screening upon completion of the study
Time Frame: Pre and post shunt revision surgery
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Pre and post shunt revision surgery
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Daniele Rigamonti, MD, Johns Hopkins School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NDX01-22-2003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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