Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device

A study will be conducted on 100 patients who undergo invasive ICP measurement due to suspected ICP elevation, regardless to etiology. Each enrolled patient will be monitored with the HS-1000 device and data will be collected throughout the entire procedure. Once the data collection is done, results of the non-invasive measurements will be analyzed accordingly. The end-point of the study is to collect at least half an hour of measurements for each participant.

Inclusion criteria

• Adult men and women subjects, aged 18 years old and over at screening visit
• Subjects with neuropathology that the principal investigator considers including in this study.
• Survival expectancy greater than 72 hours
• 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

Exclusion criteria

• Local ear infection
• 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)