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This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FlowSense | This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FlowSense | Device | This study compares the performance of two generations of non-invasive cerebrospinal fluid (CSF) shunt flow assessment devices. Measurements of functional implanted shunts and off-shunt locations will assess the diagnostic non-inferiority of the second-generation device to the first-generation device. |
| Measure | Description | Time Frame |
|---|---|---|
| Study Device Sensitivity | Study device sensitivity will be calculated as TP / (TP + FN). | Approximately 1 hour |
| Study Device Specificity | Study device specificity will be calculated as TN / (TN + FP) | Approximately 1 hour |
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Inclusion criteria
Exclusion criteria
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Pediatric and adult patients with an existing ventricular shunt will be enrolled in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa Marriott Water Street | Tampa | Florida | 33602 | United States | ||
| Rhaeos, Inc. |
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| ID | Term |
|---|---|
| D006849 | Hydrocephalus |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Chicago |
| Illinois |
| 60654 |
| United States |
| Northwest Special Recreation Association | Rolling Meadows | Illinois | 60008 | United States |