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This study evaluates the performance of a thermal anisotropy measurement device for non-invasively assessing CSF shunt flow. Patients with an existing implanted shunt and symptoms of shunt malfunction who require shunt revision surgery will be evaluated with the study device to assess flow in CSF shunts as confirmed by surgical outcomes at 7 days. If successful, this study will show that the study device accurately distinguishes between functioning (flowing) and non-functioning (non-flowing) shunts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shunted patients undergoing surgery | Patients with an existing implanted ventriculoperitoneal shunt who are experiencing shunt malfunction symptoms and require shunt revision surgery per standard of care shunt evaluation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal Anisotropy Measurement Device | Device | A wireless device for non-invasively assessing CSF shunt flow |
|
| Measure | Description | Time Frame |
|---|---|---|
| Flowsense Sensitivity | The study device will yield an output of either "flow confirmed" or "flow not confirmed." Based on this assessment and the standard-of-care clinical treatment, each subject will fall into one of the following categories: True Positive (TP): Device outputs "flow not confirmed" AND a shunt revision surgery with confirmed shunt failure is performed False Positive (FP): Device outputs "flow not confirmed" AND either no shunt revision surgery is performed for 7 days or a shunt revision surgery without a confirmed shunt failure is performed True Negative (TN): Device outputs "flow confirmed" AND either no shunt revision surgery is performed for 7 days or a shunt revision surgery without a confirmed shunt failure is performed False Negative (FN): Device outputs "flow confirmed" AND a shunt revision surgery with confirmed shunt failure is performed Study device sensitivity will be calculated as TP / (TP + FN). | Upto 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Study device specificity, diagnostic accuracy, positive predictive value (PPV), negative predictive value (NPV), and diagnostic performance | These secondary endpoints do not have associated success criteria. The study is not powered to achieve statistical significance for these endpoints. | Up to 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric and adult shunt-dependent hydrocephalus patients with an existing ventriculoperitoneal (VP) shunt who are experiencing shunt malfunction symptoms and require shunt revision surgery per standard of care shunt evaluation without use of the study device data will be enrolled in this study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Lisa Somera | Contact | 855-814-3569 | info@rhaeos.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University in St. Louis | St Louis | Missouri | 63110 | 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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