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| ID | Type | Description | Link |
|---|---|---|---|
| 5UG3NS130338 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Neurological Disorders and Stroke (NINDS) | NIH |
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This study evaluates the performance of a device for non-invasively assessing cerebrospinal fluid (CSF) shunt flow over multiple measurements performed by a study subject during activities of daily living and sleep
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Recent Revision | Experimental | Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a history of stable ventricular size, no shunt revision in the previous 2 years, and no current symptoms of shunt failure will be enrolled. |
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| Recent Revision | Experimental | Pediatric hydrocephalus patients with an existing ventricular CSF shunt and a shunt revision in the previous 7 days who the investigator judges will likely be discharged within 4 days of the enrollment date will be enrolled. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wireless thermal anisotropy measurement device | Device | Wireless wearable thermal anisotropy measurement device designed for use at home |
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse Device Effects | The co-primary endpoints in this study are the rate of ADEs and SADEs that occur per wear hour. | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| ADEs and SADEs per wear period | rate of ADEs and SADEs per wear period | 30 days |
| ADEs and SADEs per subject | rate of ADEs and SADEs per subject; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Somera | Contact | 855-814-3569 | clinical@rhaeos.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rhaeos Inc. | Chicago | Illinois | 60642 | 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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| 30 days |
| ADEs and SADEs that preclude the continued use of the study device | rate of ADEs and SADEs that preclude the continued use of the study device | 30 days |
| Device deficiencies resulting in incomplete monitoring data | percent of device deficiencies resulting in incomplete monitoring data | 30 days |
| Local skin reactions per wear session; | number of local skin reactions per wear session; | 30 days |
| Usability score | usability score based on post-study survey | 30 days |