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| ID | Type | Description | Link |
|---|---|---|---|
| 0026-14-TLV | Other Identifier | Tel Aviv Sourasky Medical Center |
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The lack of a precise diagnostic technique for cerebral vasospasm associated with traumatic brain injury (TBI) limits the ability to detect and treat this phenomenon. Surveillance Transcranial Doppler ultrasonography (TCD) is the main medical instrument that is utilized to monitor radiographic vasospasm following TBI, yet has its drawbacks such as inaccuracy, highly operator dependent and more.
HS-1000 device, an investigational vasospasm detection device, has the potential to safely diagnose and assess vasospasm with minimal discomfort to patients, allowing a new modality for vasospasm measurement tool.
We aim to evaluate the correlation between the collected and analyzed data from the HS-1000 device and the clinical findings from the TCD tests post-subarachnoid hemorrhage (SAH) patients.
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| Measure | Description | Time Frame |
|---|---|---|
| Accuracy analysis | The main goal of the study is to check the feasibility of the HeadSense's non-invasive head monitor to check vasospasm in patients which over went SAH. In order to validate the accuracy of the HeadSense's device, a statistical comparison will be done between the acoustic values from the Headsense device and the TCD outcome. | within the first 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety analysis | The HeadSense device is non-invasive and radiation free, therefore no major safety issues are expected. During the trial, the patient will be monitored to make sure that no danger or damage is caused by the device. Although there is a small chance of adverse events, potential safety issues include:
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Inclusion Criteria:
Exclusion Criteria:
Enrolled patients treatment will not change due to their participation in the trial
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SAH patients with an expected TCD test
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tel Aviv Sourasky Medical Center | Tel Aviv | 64239 | Israel |
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| within the first 48 hours |