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Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 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. Identifier: NCT02772471
Recruitment Status : Completed
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Oslo University Hospital
Information provided by (Responsible Party):
HeadSense Medical

Brief Summary:

Invasive intracranial pressure (ICP) monitoring, using modalities such as parenchymal pressure transducer or external ventricular drain (EVD), provides an ICP waveform that encapsulates valuable diagnostic and monitoring clinical information.

HS-1000 device, a proprietary new non-invasive ICP monitor, is expected to display an ICP waveform safely and accurately with minimal discomfort to patients, compared to standard invasive ICP monitoring procedures used at the participating institutions.

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

Detailed Description:
A study will be conducted on 100 patients who undergo invasive ICP measurement due to suspected ICP elevation, regardless to etiology. Each enrolled patient will be monitored with the HS-1000 device and data will be collected throughout the entire procedure. Once the data collection is done, results of the non-invasive measurements will be analyzed accordingly. The end-point of the study is to collect at least half an hour of measurements for each participant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device
Study Start Date : March 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: HS-1000 recording
ICP monitoring will be done in parallel for both HS-1000 and invasive ICP monitoring. HS-1000 ICP monitoring intervals will last at least 30 minutes, continuously depending on the patient's clinical condition.
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 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Adult men and women subjects, aged 18 years old and over at screening visit
  • Subjects with neuropathology that the principal investigator considers including in this study.
  • Survival expectancy greater than 72 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:

  • Local ear infection
  • 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)

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 identifier (NCT number): NCT02772471

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Oslo University Hospital
Oslo, Norway
Sponsors and Collaborators
HeadSense Medical
Oslo University Hospital
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Principal Investigator: Per Kristian Eide, MD, PhD Oslo University Hospital
Publications of Results:
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Responsible Party: HeadSense Medical Identifier: NCT02772471    
Other Study ID Numbers: HS-016
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
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 Injuries
Intracranial Hypertension
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries