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| Name | Class |
|---|---|
| NeuroDx Development | INDUSTRY |
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The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with pseudotumor cerebri.
The purpose of the study is to determine if the ShuntCheck test can correctly identify flow or no flow in a ventriculoperitoneal shunt in patients with pseudotumor cerebri.
Flow may be limited due to slit ventricles
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ShuntCheck | Participants will be administered the ShuntCheck diagnostic test. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ShuntCheck | Diagnostic Test | The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of ShuntCheck test | 15 minutes | |
| Negative Predictive Value of ShuntCheck test | 15 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of performing ShuntCheck test twice | 60 minutes | |
| Negative Predictive Value of performing ShuntCheck test twice | 60 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will consist of asymptomatic PTC research subjects who have a VP shunt with a single ventricular catheter implanted for PTC and are visiting for routine care.
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| Name | Affiliation | Role |
|---|---|---|
| Naomi Abel, MD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida Department of Neurological Surgery and Brain Repair | Tampa | Florida | 33606 | United States |
At present there is no plan to share any individual participant data.
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| ID | Term |
|---|---|
| D011559 | Pseudotumor Cerebri |
| ID | Term |
|---|---|
| D019586 | Intracranial Hypertension |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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