Ischemic StrokeNCT01643525
Study to Test Sensitivity and Specificity of Passive Wave Pressure Device in Determining Ischemic Stroke
An observational study of Ischemic Stroke, run by Jan Medical, Inc. at 3 sites in United States.
Trial summary
That the Jan Medical Nautilus NeuroWaveTM system provides significantly higher sensitivity to hyper acute ischemic stroke than does CT. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Nautilus NeuroWaveTM System
- Type of treatment
- Medical device
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2012to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with stroke symptoms that are being evaluated for stroke or healthy subjects that have no cerebrovascular disease and are not being evaluated for symptoms of stroke.
Who may be able to join
- Symptoms consistent with stroke with known onset < 12 hours prior to enrollment and planned recording with the Nautilus NeuroWave System
- Suspected pathology of following vessels: internal carotid artery, ACA, MCA, PCA, basilar or other anterior or posterior cerebral vessels or normal anatomy
- Subject is planned to undergo standard stroke triage imaging protocol
- Able to understand and provide signed informed consent, or have a Legally Authorized Representative willing to provide informed consent on subject's behalf
Who cannot join
- Known to meet hospital criteria for brain death
- Not a candidate for CT, MRI
- unknown time of stroke symptom onset.
- Psychologically unstable and not able to cooperate
- Not suitable for participation in this study in the opinion of the Investigator
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Johns Hopkins Hospital
Baltimore, Maryland, 21205-1911
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Howard County General Hospital
Columbia, Maryland, 21044
About this study
Official title: A NonRandomized, Multicenter, NonSig Risk Study With a NonInv, Passive PressureWave Method of Diagnosing Cerebral Anomalies to Develop a Diag. Algorithm for Cerebral Isch and to Test Sens./Spec. of This Algorithm in Determining Isch Stroke
That the Jan Medical Nautilus NeuroWaveTM system provides significantly higher sensitivity to hyper acute ischemic stroke than does CT.
Read the detailed description
In spite of the fact that approximately 800,000 strokes are diagnosed in the United States each year, many physicians and patients have approached the management of stroke with a sense of futility. However, within the past 2 decades, following the advent of computerized tomography (CT), medical interest has turned toward stroke and effective interventions to treat and prevent it have received attention.
CT and/or magnetic resonance imaging (MRI) are the typical diagnostic tools used in the event of a stroke alert. These studies are done on an emergent or urgent basis, since, to be effective, treatments for ischemic and hemorrhagic stroke must be delivered soon after onset of the illness. In an effort to institute an appropriate therapeutic regime, laboratory and structural diagnostic studies are required to be done as rapidly as possible to determine pathological etiology, size, and location of concern.
The speed at which a diagnosis is made and a treatment plan established often determines patient outcome and any associated complications. This is especially true when evaluating patients for ischemic stroke where there is a narrow 3 hour window of opportunity in which to resolve the clot with IV .before permanent neurological impairment results, and up to 8 additional hours with the use if intra arterial (IA) t-PA or interventional mechanical embolectomy procedures are utilized. Current treatment modalities include pharmacologic thrombolytic drugs utilized to disrupt or dissolve clots located in the distal vasculature or mechanical intervention in larger vessels. Since many patients do not recognize the symptoms of stroke they do not seek medical attention immediately. Significant time is then often lost from the onset of the stroke before seeking medical help / treatment.
Although the current technologies are quite adequate as diagnostic tools for hemorrhagic stroke and for identifying subdural hematomas, and other pooled blood abnormalities which would preclude t-PA therapy, they are largely ineffective at positively identifying stroke during the limited therapeutic window of time. Positive identification of ischemia itself is rarely possible or practical with CT or within the limited therapeutic window. As such the diagnostic determination and associated treatment decisions are based on the unsatisfactory basis of exclusion.
- Conditions
- Ischemic Stroke
- Being tested
- Nautilus NeuroWaveTM System
- Keywords
- Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nautilus NeuroWaveTM SystemDevice
Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with Stroke Symptoms | Suspected stroke subjects that present to hospital with stroke symptoms and are evaluated for stroke Receives: Device: Nautilus NeuroWaveTM System | |
| Normal Cohort | Subjects that are not being evaluated for stroke and are confirmed to have no cerebrovascular disease Receives: Device: Nautilus NeuroWaveTM System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Device Related Adverse Events
Count the number of participants with device related adverse events
Measured: 2-3 days, at subject exit (variation of subject exit date depended on when subject obtained their radiology imaging to confirm ischemic stroke)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Insufficient Subject Recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ischemic StrokeStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jan Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Nyquist, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643525
- Sponsor's protocol ID
- NA_00069985
- Status last verified
- Jul 2024
- First submitted
- 29 Jun 2012
- Last updated
- 8 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A NonRandomized, Multicenter, NonSig Risk Study With a NonInv, Passive PressureWave Method of Diagnosing Cerebral Anomalies to Develop a Diag. Algorithm for Cerebral Isch and to Test Sens./Spec. of This Algorithm in Determining Isch Stroke
- ClinicalTrials.gov ID
- NCT01643525
- Acronym / sponsor ID
- NA_00069985
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Insufficient Subject Recruitment
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Jan Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2012 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Posted 19 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
That the Jan Medical Nautilus NeuroWaveTM system provides significantly higher sensitivity to hyper acute ischemic stroke than does CT.
Detailed description
In spite of the fact that approximately 800,000 strokes are diagnosed in the United States each year, many physicians and patients have approached the management of stroke with a sense of futility. However, within the past 2 decades, following the advent of computerized tomography (CT), medical interest has turned toward stroke and effective interventions to treat and prevent it have received attention.
CT and/or magnetic resonance imaging (MRI) are the typical diagnostic tools used in the event of a stroke alert. These studies are done on an emergent or urgent basis, since, to be effective, treatments for ischemic and hemorrhagic stroke must be delivered soon after onset of the illness. In an effort to institute an appropriate therapeutic regime, laboratory and structural diagnostic studies are required to be done as rapidly as possible to determine pathological etiology, size, and location of concern.
The speed at which a diagnosis is made and a treatment plan established often determines patient outcome and any associated complications. This is especially true when evaluating patients for ischemic stroke where there is a narrow 3 hour window of opportunity in which to resolve the clot with IV .before permanent neurological impairment results, and up to 8 additional hours with the use if intra arterial (IA) t-PA or interventional mechanical embolectomy procedures are utilized. Current treatment modalities include pharmacologic thrombolytic drugs utilized to disrupt or dissolve clots located in the distal vasculature or mechanical intervention in larger vessels. Since many patients do not recognize the symptoms of stroke they do not seek medical attention immediately. Significant time is then often lost from the onset of the stroke before seeking medical help / treatment.
Although the current technologies are quite adequate as diagnostic tools for hemorrhagic stroke and for identifying subdural hematomas, and other pooled blood abnormalities which would preclude t-PA therapy, they are largely ineffective at positively identifying stroke during the limited therapeutic window of time. Positive identification of ischemia itself is rarely possible or practical with CT or within the limited therapeutic window. As such the diagnostic determination and associated treatment decisions are based on the unsatisfactory basis of exclusion.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with Stroke Symptoms | – | Device: Nautilus NeuroWaveTM SystemSuspected stroke subjects that present to hospital with stroke symptoms and are evaluated for stroke |
| Normal Cohort | – | Device: Nautilus NeuroWaveTM SystemSubjects that are not being evaluated for stroke and are confirmed to have no cerebrovascular disease |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with stroke symptoms that are being evaluated for stroke or healthy subjects that have no cerebrovascular disease and are not being evaluated for symptoms of stroke.
Key inclusion criteria (4 listed)
- Symptoms consistent with stroke with known onset < 12 hours prior to enrollment and planned recording with the Nautilus NeuroWave System
- Suspected pathology of following vessels: internal carotid artery, ACA, MCA, PCA, basilar or other anterior or posterior cerebral vessels or normal anatomy
- Subject is planned to undergo standard stroke triage imaging protocol
- Able to understand and provide signed informed consent, or have a Legally Authorized Representative willing to provide informed consent on subject's behalf
Key exclusion criteria (5 listed)
- Known to meet hospital criteria for brain death
- Not a candidate for CT, MRI
- unknown time of stroke symptom onset.
- Psychologically unstable and not able to cooperate
- Not suitable for participation in this study in the opinion of the Investigator
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 |
|---|---|---|
| Nautilus NeuroWaveTM SystemNon-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke. | Device | Normal Cohort, Subjects with Stroke Symptoms |
Primary outcome
Number of Participants With Device Related Adverse Events
Time frame: 2-3 days, at subject exit (variation of subject exit date depended on when subject obtained their radiology imaging to confirm ischemic stroke)
Count the number of participants with device related adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Paul Nyquist principal investigator
Johns Hopkins University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Jan Medical, Inc. at 3 sites in United States.
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 4 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: stopped early, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 19 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Device Related Adverse Events (time frame: 2-3 days, at subject exit (variation of subject exit date depended on when subject obtained their radiology imaging to confirm ischemic stroke)). 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 8 Jul 2024.