An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device

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Brief Title

An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device

Official Title

An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device

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 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.
    

Detailed Description

      A prospective study will be conducted on 80 patients with an inserted invasive
      intraparenchymal ICP monitor. Once a patient undergoes invasive ICP monitoring, has a life
      expectancy of greater than 48 hours and is 14 years old and over at the screening visit, and
      has an intact/continuous dura layer, the patient will become a candidate for enrollment into
      the study. If the patient signs the informed consent or the patient's legal authorized
      representative signs on the patient's behalf, the patient will be enrolled into the trial.
      Each enrolled patient will be monitored in parallel to the invasive ICP monitor with the
      HeadSense's device. Once the data collection is complete, results will be analyzed by
      comparing ICP readings from both devices.

      The primary end-point of the study is to collect 60-120 minutes of ICP monitoring data over
      two sessions of 30-60 minutes each for 80 neurosurgery patients of any etiology. The
      secondary endpoint of this study is evaluate the safety of the device as measured by
      incidence of adverse events and serious adverse events over each subject's 96 hours of
      participation.
    


Study Type

Interventional


Primary Outcome

Number of ICP values obtained by the HS device that correlate to ICP using current standards

Secondary Outcome

 Incidence of adverse events during and after recording sessions

Condition

Intracranial Hypertension

Intervention

HS-1000

Study Arms / Comparison Groups

 HS-1000 recording
Description:  ICP readings will be recorded in parallel from both the invasive ICP monitor, and HeadSense's non-invasive ICP monitor. Each recording session will be done until an aggregate of at least 30 minutes worth of quality data is collected, depending on the patient's clinical condition. For each patient, two recording sessions will be completed for 30-60 minutes each for 120 minutes total.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

80

Start Date

December 2015

Completion Date

December 2017

Primary Completion Date

December 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Male and female subjects, aged 14 years old and over at screening visit

          -  Patient with invasive ICP monitor due to suspected ICP elevation, regardless of
             etiology

          -  Survival expectancy greater than 48 hours

          -  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

          -  Subject with a punctured or discontinuous dura layer (must be intact)

          -  Subject with cerebral fluid (CSF) leakage

          -  Known allergy or hypersensitivity to any of the test materials or contraindication to
             test materials

          -  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)
      

Gender

All

Ages

14 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Katsuji Shima, , 

Location Countries

Japan

Location Countries

Japan

Administrative Informations


NCT ID

NCT02773888

Organization ID

HS-018


Responsible Party

Sponsor

Study Sponsor

HeadSense Medical


Study Sponsor

Katsuji Shima, Principal Investigator, National Defense Medical College


Verification Date

February 2017