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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02773888
Recruitment Status : Suspended (Recruitment temporarily held for site retraining)
First Posted : May 16, 2016
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
HeadSense Medical

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.


Condition or disease Intervention/treatment Phase
Intracranial Hypertension Brain Injuries Stroke Hydrocephalus Brain Neoplasms Device: HS-1000 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: An Evaluation of Non-Invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an Intraparenchymal Pressure Monitoring Device
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HS-1000 recording
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.
Device: HS-1000



Primary Outcome Measures :
  1. Number of ICP values obtained by the HS device that correlate to ICP using current standards [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Incidence of adverse events during and after recording sessions [ Time Frame: 96 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

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): NCT02773888


Locations
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Japan
Kuki General Hospital
Saitama, Japan
National Defense Medical College Hospital
Saitama, Japan
Juntendo University Shizuoka Hospital
Shizuoka, Japan
Nippon Medical School
Tokyo, Japan
Tokyo Jikei University Kashiwa Hospital
Tokyo, Japan
Sponsors and Collaborators
HeadSense Medical
Investigators
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Principal Investigator: Katsuji Shima National Defense Medical College
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Responsible Party: HeadSense Medical
ClinicalTrials.gov Identifier: NCT02773888    
Other Study ID Numbers: HS-018
First Posted: May 16, 2016    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by HeadSense Medical:
intracranial pressure
noninvasive monitoring
Additional relevant MeSH terms:
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Brain Neoplasms
Brain Injuries
Hydrocephalus
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms