An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an External Ventricular Drainage (EVD) Device

  • STATUS
    Not Recruiting
  • participants needed
    100
  • sponsor
    HeadSense Medical
Updated on 21 January 2021
Investigator
Rudolf Rammensee, MD
Primary Contact
Erlangen University (8.7 mi away) Contact
+6 other location

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, 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)

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 levels to the physicians

Details
Condition Presence of High Intracranial Pressure
Treatment EVD
Clinical Study IdentifierNCT02284217
SponsorHeadSense Medical
Last Modified on21 January 2021

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