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

This study is currently recruiting participants.
Verified April 2016 by HeadSense Medical
Sponsor:
ClinicalTrials.gov Identifier:
NCT02284217
First Posted: November 5, 2014
Last Update Posted: April 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
HeadSense Medical
  Purpose

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)


Condition Intervention
Presence of High Intracranial Pressure Device: EVD

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Further study details as provided by HeadSense Medical:

Primary Outcome Measures:
  • Post-hoc algorithm processing to compare ICP values (mmHg) of the HS-1000 device and invasive ICP monitor collected in each ICP monitoring cycle [ Time Frame: 2 months after last patient \ last visit ]
  • Incidence of AEs through 48 hours from end of ICP monitoring with HS-1000 device [ Time Frame: 48 hours from end of ICP monitoring ]
  • Rate of ear infections/irritations coded and graded using the adapted CTCAE dictionary provided to the site Principal Investigator (PI) [ Time Frame: 48 hours from end of ICP monitoring ]

Estimated Enrollment: 100
Study Start Date: December 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients with invasive ICP monitor (EVD)
Hospitalized patients who have already been implanted with an invasive ICP monitor. Eligible patients will be enrolled into the study and HS-1000 headset portion of the device will be placed in their ears.
Device: EVD
ICP monitoring will be done in parallel for both HS-1000 and ICP monitoring via an EVD device (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals will last from 30 minutes to 6 hours, continuously depending on the patient's clinical condition. Each such interval may occur three times a day or more depending on the clinical condition of the patient.

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 levels to the physicians
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02284217


Contacts
Contact: Nichol McBee, MPH, CCRP (410) 614-6996 nmcbee@jhmi.edu

Locations
United States, Florida
University of Miami Hospital Not yet recruiting
Miami, Florida, United States, 33136
Contact: Jonathan Jagid, MD    305-298-4594    JJagid@med.miami.edu   
Sub-Investigator: Enrique Ginzburg, MD         
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
Contact: E Francois Aldrich, M.B.,Ch.B.    410-328-0937    FAldrich@Smail.umaryland.edu   
Sub-Investigator: E Francois Aldrich, M.B.,Ch.B.         
Sinai Hospital Not yet recruiting
Baltimore, Maryland, United States, 21215
Contact: Michael A. Williams, MD, FAAN    410-601-6490    michwill@lifebridgehealth.org   
Sub-Investigator: Michael A. Williams, MD, FAAN         
The Johns Hopkins Hospital Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Alessandro Olivi, MD    410-245-2206    aolivi@jhmi.edu   
Contact: Neeraj Naval, MD    (410) 409-8087    nnaval1@jhmi.edu   
Principal Investigator: Alessandro Olivi, MD         
United States, Ohio
Metro Health Not yet recruiting
Cleveland, Ohio, United States, 44109
Contact: Michael Steinmetz, MD    216-251-6990    msteinmetz@metrohealth.org   
Sub-Investigator: Michael Steinmetz, MD         
Germany
Erlangen University Recruiting
Erlangen, Germany, 91054
Contact: Rudolf Rammensee, MD    09131-85-33001    rudolf.rammensee@uk-erlangen.de   
Sub-Investigator: Rudolf Rammensee, MD         
Klinikum Stuttgart Not yet recruiting
Stuttgart, Germany, 70174
Contact: Oliver Ganslandt, MD    0711 278-33700    o.ganslandt@klinikum-stuttgart.de   
Sub-Investigator: Oliver Ganslandt, MD         
Sponsors and Collaborators
HeadSense Medical
Investigators
Principal Investigator: Alessandro Olivi, MD Johns Hopkins University
  More Information

Responsible Party: HeadSense Medical
ClinicalTrials.gov Identifier: NCT02284217     History of Changes
Other Study ID Numbers: HS-009
First Submitted: November 3, 2014
First Posted: November 5, 2014
Last Update Posted: April 29, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No