Brain InjuriesNCT02772471
Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device
A study testing HS-1000 in people with Brain Injuries and Intracranial Hypertension, run by HeadSense Medical at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Intracranial Hypertension
- What is being tested?
- HS-1000
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Brain Injuries, Intracranial Hypertension
- Being tested
- HS-1000
- Keywords
- intracranial pressure, noninvasive monitoring
- Medical subject headings
- Brain Injuries, Intracranial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-1000Device
| Study group | Role | What they receive |
|---|---|---|
| HS-1000 recording | Experimental | 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. Receives: Device: HS-1000 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ICP values obtained by the HS device that correlate to ICP using current standards
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2016 (estimated)
- Study startMar 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- HeadSense Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Oslo University Hospital
- Responsible party
- Sponsor
- Investigators
- Per Kristian Eide, MD, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772471
- Sponsor's protocol ID
- HS-016
- Status last verified
- May 2016
- First submitted
- 12 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of the ICP Waveform Tracing Capabilities and Safety of HS-1000 Device
- ClinicalTrials.gov ID
- NCT02772471
- Acronym / sponsor ID
- HS-016
- Conditions
- Brain Injuries, Intracranial Hypertension
- Keywords
- intracranial pressure, noninvasive monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- HeadSense MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Oslo University Hospital
- Study start
- Mar 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 13 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HS-1000 recording | Experimental | Device: HS-1000ICP 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-1000 | Device | HS-1000 recording |
Primary outcome
Number of ICP values obtained by the HS device that correlate to ICP using current standards
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Results publication: PubMed 26997563Levinsky 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Kristian Eide, MD, PhD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HS-1000 in people with Brain Injuries and Intracranial Hypertension, run by HeadSense Medical at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ICP values obtained by the HS device that correlate to ICP using current standards (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02772471, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.