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This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow. Patients with an existing implanted shunt will wear the device to acquire longitudinal data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feasibility Assessment Cohort | Experimental | Non-invasive device data acquisition; study is not interventional |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal Anisotropy Measurement Device | Device | The study device is a non-invasive sensor that is placed on the study subject's skin overlying an existing implanted CSF shunt. It uses an integrated thermal actuator and temperature sensors to assess shunt flow. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin Temperature | Exploratory assessment of thermal skin measurements taken with the study device | up to 90 days |
| Acceleration | Exploratory assessment of accelerometer measurements taken with the study device | up to 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Somera | Contact | 855-814-3569 | info@rhaeos.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampa Marriott Water Street | Recruiting | Tampa | Florida | 33602 | United States |
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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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| Ann & Robert H. Lurie Children's Hospital of Chicago | Withdrawn | Chicago | Illinois | 60611 | United States |
| MATTER | Recruiting | Chicago | Illinois | 60611 | United States |
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| Northwest Special Recreation Association | Recruiting | Rolling Meadows | Illinois | 60008 | United States |
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