An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an External Ventricular Drainage (EVD) Device
Status unconfirmed · Not applicable
Conditions studied: Presence of High Intracranial Pressure
In brief
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)
Key facts
- Study ID
- NCT02284217
- Run by
- HeadSense Medical
- People needed
- 100
- Starts
- 2014-12-01
- Expected to finish
- 2017-01-01
- Last updated by the study team
- 2016-04-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify 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 qualify 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)
Where it is running
- Erlangen University — Erlangen, Germany (enrolling)
- University of Maryland Medical Center — Baltimore, Maryland, United States (enrolling)
- University of Miami Hospital — Miami, Florida, United States
- Metro Health — Cleveland, Ohio, United States
- Klinikum Stuttgart — Stuttgart, Germany
- The Johns Hopkins Hospital — Baltimore, Maryland, United States
- Sinai Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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