Presence of High Intracranial PressureNCT02284217
An Evaluation of Non-invasive ICP Monitoring in Patients Undergoing Invasive ICP Monitoring Via an External Ventricular Drainage (EVD) Device
A study testing EVD in people with Presence of High Intracranial Pressure, run by HeadSense Medical at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Presence of High Intracranial Pressure
- What is being tested?
- EVD
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Dec 2014to Jan 2017
- 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
- Patients undergoing invasive ICP monitoring via an external ventricular drainage (EVD) device for clinical management
- Survival expectancy greater than one week
- 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
- Subject with ear disease, ear trauma
- Subjects with a bony abnormality (skull defect)
- Subjects with severe head trauma in which the location and/or severity of the skull fracture(s), i.e. frank skull fracture or major joint dislocations may jeopardize HeadSense monitoring procedure
- Subjects with cerebral fluid (CSF) leakage from the ear (CSF Otorrhea)
- 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
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites, 5 recruiting
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
E Francois Aldrich, M.B.,Ch.B., 410-328-0937, FAldrich@Smail.umaryland.edu
E Francois Aldrich, M.B.,Ch.B.
- Not yet recruiting
Sinai Hospital
Baltimore, Maryland, 21215
Michael A. Williams, MD, FAAN, 410-601-6490, michwill@lifebridgehealth.org
Michael A. Williams, MD, FAAN
- Not yet recruiting
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Alessandro Olivi, MD, 410-245-2206, aolivi@jhmi.edu
Neeraj Naval, MD, (410) 409-8087, nnaval1@jhmi.edu
- Not yet recruiting
Metro Health
Cleveland, Ohio, 44109
Michael Steinmetz, MD, 216-251-6990, msteinmetz@metrohealth.org
Michael Steinmetz, MD
- Not yet recruiting
University of Miami Hospital
Miami, Florida, 33136
Jonathan Jagid, MD, 305-298-4594, JJagid@med.miami.edu
Enrique Ginzburg, MD
Germany2 sites, 2 recruiting
- Recruiting
Erlangen University
Erlangen, 91054
Rudolf Rammensee, MD, 09131-85-33001, rudolf.rammensee@uk-erlangen.de
Rudolf Rammensee, MD
- Not yet recruiting
Klinikum Stuttgart
Stuttgart, 70174
Oliver Ganslandt, MD, 0711 278-33700, o.ganslandt@klinikum-stuttgart.de
Oliver Ganslandt, MD
About this study
Official title: A Prospective, Open-Label, Non-Randomized, Comparative Study Designed to Evaluate the Accuracy and Safety of HS-1000 Device, a Non-Invasive Intracranial Pressure (ICP) Monitor, in Patients Undergoing Invasive ICP Monitoring Procedure for Various Clinical Conditions
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 new 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.
The study objective is to compare the accuracy and safety profile of HS-1000, a non-invasive ICP monitor, to invasive ICP monitoring via an external ventricular drain (EVD)
Read the detailed description
HS-1000 device, a proprietary new 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
- Conditions
- Presence of High Intracranial Pressure
- Being tested
- EVD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EVDDevice
ICP monitoring will be done in parallel for both HS-1000 and ICP monitoring via an EVD device (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals will last from 30 minutes to 6 hours, continuously depending on the patient's clinical condition. Each such interval may occur three times a day or more depending on the clinical condition of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients with invasive ICP monitor (EVD) | Experimental | Hospitalized patients who have already been implanted with an invasive ICP monitor. Eligible patients will be enrolled into the study and HS-1000 headset portion of the device will be placed in their ears. Receives: Device: EVD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-hoc algorithm processing to compare ICP values (mmHg) of the HS-1000 device and invasive ICP monitor collected in each ICP monitoring cycle
Measured: 2 months after last patient \ last visit
Incidence of AEs through 48 hours from end of ICP monitoring with HS-1000 device
Measured: 48 hours from end of ICP monitoring
Rate of ear infections/irritations coded and graded using the adapted CTCAE dictionary provided to the site Principal Investigator (PI)
Measured: 48 hours from end of ICP monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionOct 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Presence of High Intracranial PressureStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeadSense Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alessandro Olivi, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284217
- Sponsor's protocol ID
- HS-009
- Status last verified
- Apr 2016
- First submitted
- 3 Nov 2014
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open-Label, Non-Randomized, Comparative Study Designed to Evaluate the Accuracy and Safety of HS-1000 Device, a Non-Invasive Intracranial Pressure (ICP) Monitor, in Patients Undergoing Invasive ICP Monitoring Procedure for Various Clinical Conditions
- ClinicalTrials.gov ID
- NCT02284217
- Acronym / sponsor ID
- HS-009
- Conditions
- Presence of High Intracranial Pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- HeadSense MedicalIndustry (pharma, biotech, devices)
- Study start
- Dec 2014
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 5 Nov 2014 (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 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 new 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.
The study objective is to compare the accuracy and safety profile of HS-1000, a non-invasive ICP monitor, to invasive ICP monitoring via an external ventricular drain (EVD)
Detailed description
HS-1000 device, a proprietary new 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
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with invasive ICP monitor (EVD) | Experimental | Device: EVDHospitalized patients who have already been implanted with an invasive ICP monitor. Eligible patients will be enrolled into the study and HS-1000 headset portion of the device will be placed in their ears. |
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
- Patients undergoing invasive ICP monitoring via an external ventricular drainage (EVD) device for clinical management
- Survival expectancy greater than one week
- 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 (8 listed)
- Subject with ear disease, ear trauma
- Subjects with a bony abnormality (skull defect)
- Subjects with severe head trauma in which the location and/or severity of the skull fracture(s), i.e. frank skull fracture or major joint dislocations may jeopardize HeadSense monitoring procedure
- Subjects with cerebral fluid (CSF) leakage from the ear (CSF Otorrhea)
- Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
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 |
|---|---|---|
| EVDICP monitoring will be done in parallel for both HS-1000 and ICP monitoring via an EVD device (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals will last from 30 minutes to 6 hours, continuously depending on the patient's clinical condition. Each such interval may occur three times a day or more depending on the clinical condition of the patient. | Device | Patients with invasive ICP monitor (EVD) |
Primary outcome
Post-hoc algorithm processing to compare ICP values (mmHg) of the HS-1000 device and invasive ICP monitor collected in each ICP monitoring cycle
Time frame: 2 months after last patient \ last visit
Incidence of AEs through 48 hours from end of ICP monitoring with HS-1000 device
Time frame: 48 hours from end of ICP monitoring
Rate of ear infections/irritations coded and graded using the adapted CTCAE dictionary provided to the site Principal Investigator (PI)
Time frame: 48 hours from end of ICP monitoring
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Individual participant dataSharing planned: No
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.
Alessandro Olivi, MD principal investigator
Johns Hopkins University
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EVD in people with Presence of High Intracranial Pressure, run by HeadSense Medical at 7 sites in 2 countries.
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 8 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: status not confirmed, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nichol McBee, MPH, CCRP ((410) 614-6996, nmcbee@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-hoc algorithm processing to compare ICP values (mmHg) of the HS-1000 device and invasive ICP monitor collected in each ICP monitoring cycle (time frame: 2 months after last patient \ last visit). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2016.