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

HeadSense Medical

Status: Withdrawn

Conditions: Sub Arachnoid Hemorrhage; Vasospasm

Study type: Observational

Funder types: Industry

Identifiers

NCT02093182

0026-14-TLV (Other Identifier)

HS-007

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• SAH patients with a TCD test
• Male or Female in the age range of 18-85 years
• Expected survival > 14 days

Exclusion criteria

• Local infection in the ear.
• Pregnant/lactating women
• Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
• Subjects currently enrolled in or less than 30 days post-participation in other investigational device or drug study(s), or receiving other investigational agent(s)
• Any condition that may jeopardize study participation (e.g., abnormal clinical or laboratory finding) or interpretation of study results, or may impede the ability to obtain informed consent (e.g., mental condition) Note: As the trial does not affect the patient's management, there is no limitation regarding patient's medications, previous or post study procedures, etc.

Enrolled patients treatment will not change due to their participation in the trial