NCT02093182

An Innovative Non-invasive Acoustic Approach to Detect and Monitor Cerebral Vasospasm

A Retrospective, Open-Label, Non-Randomized, Study Designed to Evaluate the Correlation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Vasospasm Patients After Sub Arachnoid Hemorrhage

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: HeadSense Medical · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Sub Arachnoid Hemorrhage
• Vasospasm

Timeline

• Primary completion: 2014-10-01
• Completion: 2014-10-01
• First posted: 2014-03-20
• Last updated: 2016-12-22

Locations

1 site across 1 country: Israel