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Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device

Primary Purpose

Brain Injuries, Intracranial Hypertension

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
HS-1000
Sponsored by
HeadSense Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Injuries focused on measuring intracranial pressure, noninvasive monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Oslo University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HS-1000 recording

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2016
Last Updated
May 12, 2016
Sponsor
HeadSense Medical
Collaborators
Oslo University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02772471
Brief Title
Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device
Official Title
Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HeadSense Medical
Collaborators
Oslo University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Intracranial Hypertension
Keywords
intracranial pressure, noninvasive monitoring

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HS-1000 recording
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
HS-1000
Primary Outcome Measure Information:
Title
Number of ICP values obtained by the HS device that correlate to ICP using current standards
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Per Kristian Eide, MD, PhD
Organizational Affiliation
Oslo University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oslo University Hospital
City
Oslo
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26997563
Citation
Levinsky A, Papyan S, Weinberg G, Stadheim T, Eide PK. Non-invasive estimation of static and pulsatile intracranial pressure from transcranial acoustic signals. Med Eng Phys. 2016 May;38(5):477-84. doi: 10.1016/j.medengphy.2016.02.009. Epub 2016 Mar 17.
Results Reference
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Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device

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