An observational study in Sub Arachnoid Hemorrhage and Vasospasm, sponsored by HeadSense Medical. Withdrawn at 1 site in Israel. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-12-22.
Sponsored by HeadSense Medical · Observational
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.
509 studies on the registry are indexed under Subarachnoid Hemorrhage; 124 are open to participants now.
Browse Subarachnoid Hemorrhage studies →HeadSense Medical is the lead sponsor of 11 studies on the registry; none are open to participants now.
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SAH patients with an expected TCD test
Exclusion Criteria:
Enrolled patients treatment will not change due to their participation in the trial
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.
Time frame: within the first 30 days
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: * Perforation of the ear drum, caused by inserting the device to the patient's ears * Allergic reaction caused by skin contact with the device (the parts that are attached to the skin are taken from an off the shelf stethoscope, so this is very unlikely to happen) * Damage to hearing, caused by the generated sound (the sound is 10Db in strength and is being generated for 10 seconds, so hearing damage is very unlikely to happen
Time frame: within the first 48 hours
This study is withdrawn, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.
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