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

NCT02284217 | Unknown DMC

• 1 other identifier: HS-009
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 7

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, 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)

Conditions

Presence of High Intracranial Pressure

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Patients with invasive ICP monitor (EVD)

EXPERIMENTAL

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

Interventions

EVD DEVICE

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.

Patients with invasive ICP monitor (EVD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• HeadSense Medical: lead

Study Sites (7)

University of Miami Hospital

Miami, Florida, 33136, United States

NOT YET RECRUITING

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

Sinai Hospital

Baltimore, Maryland, 21215, United States

NOT YET RECRUITING

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

NOT YET RECRUITING

Metro Health

Cleveland, Ohio, 44109, United States

NOT YET RECRUITING

Erlangen University

Erlangen, 91054, Germany

RECRUITING

Klinikum Stuttgart

Stuttgart, 70174, Germany

NOT YET RECRUITING

Study Officials

• Alessandro Olivi, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nichol McBee, MPH, CCRP

CONTACT

(410) 614-6996; nmcbee@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2014
• First Posted: November 5, 2014
• Study Start: December 1, 2014
• Primary Completion: October 1, 2016
• Study Completion: January 1, 2017
• Last Updated: April 29, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2); US (5)