Sub Arachnoid HemorrhageNCT02093182
An Innovative Non-invasive Acoustic Approach to Detect and Monitor Cerebral Vasospasm
An observational study of Sub Arachnoid Hemorrhage and Vasospasm, run by HeadSense Medical at 1 site in Israel.
Trial summary
The lack of a precise diagnostic technique for cerebral vasospasm associated with traumatic brain injury (TBI) limits the ability to detect and treat this phenomenon. Surveillance Transcranial Doppler ultrasonography (TCD) is the main medical instrument that is utilized to monitor radiographic vasospasm following TBI… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Sub Arachnoid Hemorrhage, Vasospasm
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento Oct 2014
- Phase
- Observational
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: SAH patients with an expected TCD test
Who may be able to join
- SAH patients with a TCD test
- Male or Female in the age range of 18-85 years
- Expected survival > 14 days
Who cannot join
- Local infection in the ear.
- Pregnant/lactating women
- Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
- 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) Note: As the trial does not affect the patient's management, there is no limitation regarding patient's medications, previous or post study procedures, etc.
- Enrolled patients treatment will not change due to their participation in the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective, Open-Label, Non-Randomized, Study Designed to Evaluate the Correlation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Vasospasm Patients After Sub Arachnoid Hemorrhage
The lack of a precise diagnostic technique for cerebral vasospasm associated with traumatic brain injury (TBI) limits the ability to detect and treat this phenomenon. Surveillance Transcranial Doppler ultrasonography (TCD) is the main medical instrument that is utilized to monitor radiographic vasospasm following TBI, yet has its drawbacks such as inaccuracy, highly operator dependent and more.
HS-1000 device, an investigational vasospasm detection device, has the potential to safely diagnose and assess vasospasm with minimal discomfort to patients, allowing a new modality for vasospasm measurement tool.
We aim to evaluate the correlation between the collected and analyzed data from the HS-1000 device and the clinical findings from the TCD tests post-subarachnoid hemorrhage (SAH) patients.
- Conditions
- Sub Arachnoid Hemorrhage, Vasospasm
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy analysis
The main goal of the study is to check the feasibility of the HeadSense's non-invasive head monitor to check vasospasm in patients which over went SAH. In order to validate the accuracy of the HeadSense's device, a statistical comparison will be done between the acoustic values from the Headsense device and the TCD outcome.
Measured: within the first 30 days
Secondary outcomes (1)
Safety analysis
The HeadSense device is non-invasive and radiation free, therefore no major safety issues are expected.
During the trial, the patient will be monitored to make sure that no danger or damage is caused by the device. Although there is a small chance of adverse events, potential safety issues include:
- Perforation of the ear drum, caused by inserting the device to the patient's ears
- Allergic reaction caused by skin contact with the device (the parts that are attached to the skin are taken from an off the shelf stethoscope, so this is very unlikely to happen)
- Damage to hearing, caused by the generated sound (the sound is 10Db in strength and is being generated for 10 seconds, so hearing damage is very unlikely to happen
Measured: within the first 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Primary completionOct 2014
- Study completionOct 2014
Why it stopped: Agreement not executed between site and sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sub Arachnoid HemorrhageStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- HeadSense Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093182
- Sponsor's protocol ID
- HS-007
- Other IDs
- 0026-14-TLV
- Status last verified
- Dec 2016
- First submitted
- 19 Mar 2014
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Open-Label, Non-Randomized, Study Designed to Evaluate the Correlation of HS-1000 Device Capabilities in the Diagnosis and Assessment of Vasospasm Patients After Sub Arachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT02093182
- Acronym / sponsor ID
- HS-007
- Conditions
- Sub Arachnoid Hemorrhage, Vasospasm
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Agreement not executed between site and sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- HeadSense MedicalIndustry (pharma, biotech, devices)
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 20 Mar 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.
The lack of a precise diagnostic technique for cerebral vasospasm associated with traumatic brain injury (TBI) limits the ability to detect and treat this phenomenon. Surveillance Transcranial Doppler ultrasonography (TCD) is the main medical instrument that is utilized to monitor radiographic vasospasm following TBI, yet has its drawbacks such as inaccuracy, highly operator dependent and more.
HS-1000 device, an investigational vasospasm detection device, has the potential to safely diagnose and assess vasospasm with minimal discomfort to patients, allowing a new modality for vasospasm measurement tool.
We aim to evaluate the correlation between the collected and analyzed data from the HS-1000 device and the clinical findings from the TCD tests post-subarachnoid hemorrhage (SAH) patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- SAH patients with an expected TCD test
Key inclusion criteria (3 listed)
- SAH patients with a TCD test
- Male or Female in the age range of 18-85 years
- Expected survival > 14 days
Key exclusion criteria (6 listed)
- Local infection in the ear.
- Pregnant/lactating women
- Known allergy or hypersensitivity to any of the test materials or contraindication to test materials
- 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) Note: As the trial does not affect the patient's management, there is no limitation regarding patient's medications, previous or post study procedures, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy analysis
Time frame: within the first 30 days
The main goal of the study is to check the feasibility of the HeadSense's non-invasive head monitor to check vasospasm in patients which over went SAH. In order to validate the accuracy of the HeadSense's device, a statistical comparison will be done between the acoustic values from the Headsense device and the TCD outcome.
1 secondary outcome
Safety analysis
Time frame: within the first 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2016.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sub Arachnoid Hemorrhage and Vasospasm, run by HeadSense Medical at 1 site in Israel.
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 3 inclusion and 6 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: withdrawn, as of the sponsor's last update on 22 Dec 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 Israel. 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 was withdrawn before enrolling participants, so there are no results.
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?
Accuracy analysis (time frame: within the first 30 days). 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 22 Dec 2016.