Status:
UNKNOWN
An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an External Ventricular Drainage (EVD) Device
Lead Sponsor:
HeadSense Medical
Conditions:
Presence of High Intracranial Pressure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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,...
Detailed Description
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 l...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2017
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02284217
Start Date
December 1 2014
End Date
January 1 2017
Last Update
April 29 2016
Active Locations (7)
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1
University of Miami Hospital
Miami, Florida, United States, 33136
2
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
3
Sinai Hospital
Baltimore, Maryland, United States, 21215
4
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287