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

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)

Study Overview

• Status: Unknown
• Conditions: Presence of High Intracranial Pressure
• Intervention / Treatment: Device: EVD

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

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Incidence of AEs through 48 hours from end of ICP monitoring with HS-1000 device	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)	48 hours from end of ICP monitoring

Collaborators and Investigators

• Sponsor: HeadSense Medical
• Investigators: Principal Investigator: Alessandro Olivi, MD, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: November 3, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 5, 2014

Study Record Updates

• Last Update Posted (Estimate): April 29, 2016
• Last Update Submitted That Met QC Criteria: April 27, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: HS-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No