Presence of High Intracranial Pressure Clinical Trial
Official title:
A Prospective, Open-Label, Non-Randomized, Comparative Study Designed to Evaluate the Accuracy and Safety of HS-1000 Device, a Non-Invasive Intracranial Pressure (ICP) Monitor, in Patients Undergoing Invasive ICP Monitoring Procedure for Various Clinical Conditions
Invasive intracranial pressure (ICP) monitoring is highly effective, but involves risks.
HS-1000 measures ICP non-invasively by assessing the acoustic properties of the patient's
head. 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.
The study objective is to compare the accuracy and safety profile of HS-1000, a non-invasive
ICP monitor, to invasive ICP monitoring via an external ventricular drain (EVD)
| Status | Recruiting |
| Enrollment | 100 |
| Est. completion date | January 2017 |
| Est. primary completion date | October 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
| Country | Name | City | State |
|---|---|---|---|
| Germany | Erlangen University | Erlangen | |
| Germany | Klinikum Stuttgart | Stuttgart | |
| United States | Sinai Hospital | Baltimore | Maryland |
| United States | The Johns Hopkins Hospital | Baltimore | Maryland |
| United States | University of Maryland Medical Center | Baltimore | Maryland |
| United States | Metro Health | Cleveland | Ohio |
| United States | University of Miami Hospital | Miami | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| HeadSense Medical |
United States, Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Post-hoc algorithm processing to compare ICP values (mmHg) of the HS-1000 device and invasive ICP monitor collected in each ICP monitoring cycle | 2 months after last patient \ last visit | No | |
| Primary | Incidence of AEs through 48 hours from end of ICP monitoring with HS-1000 device | 48 hours from end of ICP monitoring | Yes | |
| Primary | Rate of ear infections/irritations coded and graded using the adapted CTCAE dictionary provided to the site Principal Investigator (PI) | 48 hours from end of ICP monitoring | Yes |