HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to safely and accurately monitor ICP with minimal discomfort to patients, and provide information about normal or elevated ICP levels to the physicians
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Adult men and women subjects, aged 18 years old and over at screening visit
Patients undergoing invasive ICP monitoring via an external ventricular drainage (EVD) device for clinical management
Survival expectancy greater than one week
Subject or legal authorized representative (per local regulation) is able and willing to comply with the requirements of the protocol
Subject or legal authorized representative (per local regulation) is able to understand and sign written informed consent to participate in the study
You may not be if
Subject with ear disease, ear trauma
Subjects with a bony abnormality (skull defect)
Subjects with severe head trauma in which the location and/or severity of the skull fracture(s), i.e. frank skull fracture or major joint dislocations may jeopardize HeadSense monitoring procedure
Subjects with cerebral fluid (CSF) leakage from the ear (CSF Otorrhea)
Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
For women of childbearing potential: pregnancy (positive pregnancy test) or breast-feeding
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)
