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CompletedNCT02772471Updated May 13, 2016

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

An interventional study of HS-1000 in Brain Injuries and Intracranial Hypertension, sponsored by HeadSense Medical. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-13.

Sponsored by HeadSense Medical · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Brain Injuries
  • Intracranial Hypertension

Keywords

  • intracranial pressure
  • noninvasive monitoring
03

In context

Brain Injuries

2,125 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.

This study's enrollment of 40 is below the median of 48 across 1,341 interventional studies indexed under Brain Injuries.

Browse Brain Injuries studies →

Lead sponsor

HeadSense Medical is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • 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

Interventions

  • DeviceHS-1000
06

What researchers measure

Primary outcomes

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

    Time frame: 30 minutes

07

Study locations

1 site
  • Oslo University Hospital
    Oslo, Norway
08

References and documents

Publications

  • 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. PubMed 26997563 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2014, a primary completion of Dec 2014 and a completion of Dec 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 12, 2016
First posted
May 13, 2016
Start
Mar 2014
Primary completionActual
Dec 2014
CompletionActual
Dec 2014
Last update
May 13, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02772471
Lead sponsor
HeadSense Medical
Collaborators
Oslo University Hospital
Responsible party
Sponsor
First posted
May 13, 2016
Start date
Mar 2014
Primary completion
Dec 2014
Completion
Dec 2014
Last update
May 13, 2016

Study contacts

Per Kristian Eide, MD, PhD
principal investigator · Oslo University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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