Hemorrhagic StrokeNCT03827720
Early Feasibility Study of the SENSE Device
A study testing SENSE Device in people with Hemorrhagic Stroke and Ischemic Stroke, run by Sense Diagnostics, LLC at 2 sites in United States.
Trial summary
A single site, study of the SENSE device in up to 20 study subjects, (five healthy controls and five each with ICH, AIS with LVO and AIS without LVO) in whom SENSE can be applied within 24 hours of stroke symptom onset. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemorrhagic Stroke, Ischemic Stroke
- What is being tested?
- SENSE Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- 6 Jun 2019to 4 Jan 2021
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female patients age 22 years and older
- Established diagnosis of AIS (with or without LVO) or ICH within 24 hours of symptom onset
- Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian
- Willingness and ability to comply with 45 minutes of SENSE monitoring per study procedures
- Attending (Treating) physician has indicated that the patient is stable and has approved the patient's participation in the study
Who cannot join
- Female patients who are pregnant or lactating
- Patients with a known seizure disorder or those who have a seizure at stroke onset
- Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the SENSE device monitoring or study participation or may confound the outcome of the study
- Intraventricular hemorrhage requiring emergent ventriculostomy placement on the eligibility CT or MRI
- Secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis, trauma)
- Pontine or infratentorial location of ICH
- In AIS patients, treatment with intravenous alteplase and/or mechanical thrombectomy prior to the initiation of 45 minutes of SENSE monitoring
- Current participation in an interventional clinical trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
TriHealth Hatton Research Institute - Good Samaritan Hospital
Cincinnati, Ohio, 45212
UC Health
Cincinnati, Ohio, 45219
About this study
Official title: An Early Feasibility Study of the SENSE Device in Healthy Volunteers and Patients With Hemorrhagic Stroke, Ischemic Stroke With Large Vessel Occlusion, and Ischemic Stroke Without Large Vessel Occlusion
A single site, study of the SENSE device in up to 20 study subjects, (five healthy controls and five each with ICH, AIS with LVO and AIS without LVO) in whom SENSE can be applied within 24 hours of stroke symptom onset.
Read the detailed description
This will be a single site, study of the SENSE device in up to 20 study subjects, (five healthy controls and five each with ICH, AIS with LVO and AIS without LVO) in whom SENSE can be applied within 24 hours of stroke symptom onset. LVO will be defined as occlusion of the internal carotid artery (ICA) or middle cerebral artery (M1 or M2). All images in stroke patients will be reviewed by an independent neuroradiologist and final diagnoses ascertained by an independent neurologist. The treating clinicians will be blinded to the data collection and SENSE device scanning as described below.
A history and physical examination will be performed by the treating physician, and routine evaluations (including a diagnostic head CT/CT angiogram or MR/MR angiogram). All eligible subjects must have the diagnostic head CT/MR scan and clinical diagnosis of a stroke (ICH, AIS with LVO or AIS without LVO) performed within 24 hours of symptom onset.
Eligible subjects or legally authorized representatives will be approached for enrollment. Prior to obtaining informed consent, concurrence of patients' eligibility for this study and an assertion that the patient is clinically stable will be obtained from the treating team and its attending physician prior to obtaining informed consent. After obtaining informed consent to participate in the study, the SENSE device will be placed on the subject and monitoring will proceed over 45 minutes. A research coordinator will be present at the bedside for the 45 minutes of SENSE monitoring.
After enrollment, routine clinical management will ensue in the emergency department (ED), hospital ward or intensive care unit (ICU) as appropriate. A standard of care head CT with or without CT angiography or MR with or without angiography performed prior to diagnosis will be collected and analyzed. All enrolled AIS subjects must have a CT or MR angiography performed within 24 hours to establish absence or presence of LVO. Study procedures shall not delay, detract or interfere with medically necessary care or with planned treatments.
The SENSE device will be placed on the subject's head, and two small ink dots will be marked on the head corresponding to a known location on the device to allow for the device to be removed and replaced consistently throughout the 45 minutes of testing.
- Conditions
- Hemorrhagic Stroke, Ischemic Stroke
- Being tested
- SENSE Device
- Medical subject headings
- Hemorrhagic Stroke, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSE DeviceDevice
Also called CT Scan
Non-invasive radiofrequency (RF) sensor
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Healthy volunteers monitored with Sense Device Receives: Device: SENSE Device |
| Intracranial Hemorrhage | Experimental | Intracranial hemorrhage patients monitored with Sense Device Receives: Device: SENSE Device |
| Acute Ischemic Stroke with LOV | Experimental | Acute Ischemic Stroke patients that have large vessel occlusion monitored with SENSE Device Receives: Device: SENSE Device |
| AIS without LOV | Experimental | Ischemic Stroke patients that do not have large vessel occlusion monitored with SENSE device Receives: Device: SENSE Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of SENSE signal with CT scan for stroke severity (location), hemorrhage volume (ABC method) and AIS LOV status (presence and location)
The change in received power (PR) measured by the SENSE device will be calculated and the accuracy of the SENSE algorithm will be tested for the SENSE measurement that correspond with diagnostic CT scan for stroke severity, hemorrhage volume and in the case of AIS, presence or absence of LVO..
Measured: 45 minutes
Secondary outcomes (2)
Number of participants that completed the 45 mins monitoring session with the Sense Device successfully through confirmation that all planned data has been collected.
The ability to process collected data in a manner that allows application and use of the SENSE device in a clinical environment through assessment of all participants that have complete SENSE Device data.
Measured: 45 minutes
Number of participants with adverse events (AE), unanticipated adverse device effects (UADE) and serious adverse events (SAE) as defined in the protocol.
Preliminary estimate of the safety of the device when used in a clinical setting through tabulation and summary of AEs, UADEs and SAEs.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start6 Jun 2019
- Primary completion19 Nov 2020
- Study completion4 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhagic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The Sensor Evaluation of Neurologic Status in Emergencies (SENSE) device (Sense Diagnostics LLC; Cincinnati, OH) is a non-invasive radiofrequency (RF) sensor that detects and monitors intracranial hemorrhage (ICH).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sense Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andrew Ringer, MD, Principal investigator, TriHealth Hatton Research Institute - Good Samaritan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827720
- Sponsor's protocol ID
- SENSE-002
- Status last verified
- Jul 2021
- First submitted
- 28 Jan 2019
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility Study of the SENSE Device in Healthy Volunteers and Patients With Hemorrhagic Stroke, Ischemic Stroke With Large Vessel Occlusion, and Ischemic Stroke Without Large Vessel Occlusion
- ClinicalTrials.gov ID
- NCT03827720
- Acronym / sponsor ID
- SENSE-002
- Conditions
- Hemorrhagic Stroke, Ischemic Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sense Diagnostics, LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Jun 2019 (actual)
- Primary completion
- 19 Nov 2020 (actual)
- Study completion
- 4 Jan 2021 (actual)
- First posted
- 1 Feb 2019 (actual)
- 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.
A single site, study of the SENSE device in up to 20 study subjects, (five healthy controls and five each with ICH, AIS with LVO and AIS without LVO) in whom SENSE can be applied within 24 hours of stroke symptom onset.
Detailed description
This will be a single site, study of the SENSE device in up to 20 study subjects, (five healthy controls and five each with ICH, AIS with LVO and AIS without LVO) in whom SENSE can be applied within 24 hours of stroke symptom onset. LVO will be defined as occlusion of the internal carotid artery (ICA) or middle cerebral artery (M1 or M2). All images in stroke patients will be reviewed by an independent neuroradiologist and final diagnoses ascertained by an independent neurologist. The treating clinicians will be blinded to the data collection and SENSE device scanning as described below.
A history and physical examination will be performed by the treating physician, and routine evaluations (including a diagnostic head CT/CT angiogram or MR/MR angiogram). All eligible subjects must have the diagnostic head CT/MR scan and clinical diagnosis of a stroke (ICH, AIS with LVO or AIS without LVO) performed within 24 hours of symptom onset.
Eligible subjects or legally authorized representatives will be approached for enrollment. Prior to obtaining informed consent, concurrence of patients' eligibility for this study and an assertion that the patient is clinically stable will be obtained from the treating team and its attending physician prior to obtaining informed consent. After obtaining informed consent to participate in the study, the SENSE device will be placed on the subject and monitoring will proceed over 45 minutes. A research coordinator will be present at the bedside for the 45 minutes of SENSE monitoring.
After enrollment, routine clinical management will ensue in the emergency department (ED), hospital ward or intensive care unit (ICU) as appropriate. A standard of care head CT with or without CT angiography or MR with or without angiography performed prior to diagnosis will be collected and analyzed. All enrolled AIS subjects must have a CT or MR angiography performed within 24 hours to establish absence or presence of LVO. Study procedures shall not delay, detract or interfere with medically necessary care or with planned treatments.
The SENSE device will be placed on the subject's head, and two small ink dots will be marked on the head corresponding to a known location on the device to allow for the device to be removed and replaced consistently throughout the 45 minutes of testing.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The Sensor Evaluation of Neurologic Status in Emergencies (SENSE) device (Sense Diagnostics LLC; Cincinnati, OH) is a non-invasive radiofrequency (RF) sensor that detects and monitors intracranial hemorrhage (ICH).
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Device: SENSE DeviceHealthy volunteers monitored with Sense Device |
| Intracranial Hemorrhage | Experimental | Device: SENSE DeviceIntracranial hemorrhage patients monitored with Sense Device |
| Acute Ischemic Stroke with LOV | Experimental | Device: SENSE DeviceAcute Ischemic Stroke patients that have large vessel occlusion monitored with SENSE Device |
| AIS without LOV | Experimental | Device: SENSE DeviceIschemic Stroke patients that do not have large vessel occlusion monitored with SENSE device |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients age 22 years and older
- Established diagnosis of AIS (with or without LVO) or ICH within 24 hours of symptom onset
- Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian
- Willingness and ability to comply with 45 minutes of SENSE monitoring per study procedures
- Attending (Treating) physician has indicated that the patient is stable and has approved the patient's participation in the study
Key exclusion criteria (8 listed)
- Female patients who are pregnant or lactating
- Patients with a known seizure disorder or those who have a seizure at stroke onset
- Presence or history of any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for the SENSE device monitoring or study participation or may confound the outcome of the study
- Intraventricular hemorrhage requiring emergent ventriculostomy placement on the eligibility CT or MRI
- Secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis, trauma)
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 |
|---|---|---|
| SENSE DeviceAlso: CT ScanNon-invasive radiofrequency (RF) sensor | Device | AIS without LOV, Acute Ischemic Stroke with LOV, Control, Intracranial Hemorrhage |
Primary outcome
Correlation of SENSE signal with CT scan for stroke severity (location), hemorrhage volume (ABC method) and AIS LOV status (presence and location)
Time frame: 45 minutes
The change in received power (PR) measured by the SENSE device will be calculated and the accuracy of the SENSE algorithm will be tested for the SENSE measurement that correspond with diagnostic CT scan for stroke severity, hemorrhage volume and in the case of AIS, presence or absence of LVO..
2 secondary outcomes
Number of participants that completed the 45 mins monitoring session with the Sense Device successfully through confirmation that all planned data has been collected.
Time frame: 45 minutes
Number of participants with adverse events (AE), unanticipated adverse device effects (UADE) and serious adverse events (SAE) as defined in the protocol.
Time frame: 7 days
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 2 Jul 2021.
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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.
Andrew Ringer, MD principal investigator
TriHealth Hatton Research Institute - Good Samaritan Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SENSE Device in people with Hemorrhagic Stroke and Ischemic Stroke, run by Sense Diagnostics, LLC at 2 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 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: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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?
Correlation of SENSE signal with CT scan for stroke severity (location), hemorrhage volume (ABC method) and AIS LOV status (presence and location) (time frame: 45 minutes). 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 2 Jul 2021.