An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device


Phase N/A Results N/A

Eligibility Criteria

Inclusion Criteria

- Male and female subjects, aged 14 years old and over at screening visit
- Patient with invasive ICP monitor due to suspected ICP elevation, regardless of etiology
- Survival expectancy greater than 48 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

- Subject with ear disease, ear trauma
- Subject with a punctured or discontinuous dura layer (must be intact)
- Subject with cerebral fluid (CSF) leakage
- 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)