Intracerebral HemorrhageNCT03038087
A Study to Test the SENSE Device in Patients With Intracranial Hemorrhage
A study testing SENSE Device in people with Intracerebral Hemorrhage and Stroke, Acute, run by Sense Diagnostics, LLC at 1 site in United States.
Trial summary
The purpose of this research study is to find out whether a device for monitoring bleeding in patients with acute hemorrhagic stroke will show similar findings as CT scans performed to evaluate the stroke. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Intracerebral Hemorrhage, Stroke, Acute, Stroke Hemorrhagic
- 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
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Feb 2017to 31 Dec 2017
- Phase
- Interventional
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients age 22 years and older
- Diagnostic head CT scan within 24 hours of primary spontaneous ICH symptom onset
- ICH >3mL and <90mL, as measured by the ABC method
- 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 schedule for study procedures
Who cannot join
- Female patients who are pregnant or lactating
- Patients with any history of seizure or 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
- Any intraventricular hemorrhage on the diagnostic (pre-enrollment) CT with planned placement of an intraventricular catheter
- Secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis, trauma)
- Planned withdrawal of care within 24 hours of enrollment
Show all 12Show fewer
- Planned surgical evacuation within 24 hours of enrollment
- Current participation in a medical or surgical interventional clinical trial
- Presence of subdural, epidural or aneurysmal subarachnoid hemorrhage on diagnostic scan
- Planned continued use or prescribed use during the study of medications that, in the investigator's best clinical judgment, are known or suspected to lower the seizure threshold
- Planned continued use of medications that, in the investigator's best clinical judgment, could increase the chances for subsequent uncontrolled hemorrhage
- Planned or current use of continuous EEG monitoring
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
About this study
Official title: An Early Feasibility Study to Evaluate the User Interfaces and Sensitivity of the SENSE Device in Patients With Intracranial Hemorrhage
The purpose of this research study is to find out whether a device for monitoring bleeding in patients with acute hemorrhagic stroke will show similar findings as CT scans performed to evaluate the stroke.
Read the detailed description
This will be a prospective, observational, single site, first-in-man study of the SENSE device in up to 10 study subjects with primary spontaneous ICH. The treating clinicians will be blinded to the data collection and SENSE device scanning as described below.
All eligible subjects must have the diagnostic head CT scan (CT) demonstrating hemorrhage performed within 6 hours of symptom onset. While ICH and TBI patients may be evaluated in future studies, this early feasibility study is limited to primary spontaneous ICH patients only, given the relative homogeneity of this population compared with the TBI population.
Eligible subjects or legally authorized representatives will be approached for enrollment. After obtaining informed consent to participate in the study, a baseline study head CT will be performed to establish the hemorrhage volume; and the SENSE device will be placed on the subject within 15 minutes of this CT, or as soon as practicable, for initiation of monitoring. This repeat CT (after the diagnostic CT) is necessary since hemorrhage expansion (HE) occurs early in the clinical course, and the hemorrhage volume may have changed between the diagnostic CT and placement of the SENSE monitor.
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 to evaluate for HE will be performed at 12 (±6) hours after the baseline study head CT. Finally, a study head CT will be performed at 72 (±12) hours to evaluate cerebral edema. Any head CT performed for clinical deterioration as standard of care between the baseline and 72 hour study CTs will also be collected and analyzed.
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 testing. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. If the SENSE device is removed to perform the CT or SENSE monitoring is temporarily suspended, the SENSE device will be replaced; and SENSE monitoring will resume within 15 minutes, or as soon as practicable, after each CT scan. A SENSE measurement obtained within 15 minutes of each CT scan, or as soon as practicable thereafter, will be used for comparison with data analysis.
- Conditions
- Intracerebral Hemorrhage, Stroke, Acute, Stroke Hemorrhagic
- Being tested
- SENSE Device
- Medical subject headings
- Cerebral Hemorrhage, Stroke, Hemorrhagic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SENSE DeviceDevice
The SENSE device transmits a low power tailored electro-magnetic pulse across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:
- A molded plastic headpiece containing the antenna array, and
- A processing control unit.
The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device.
| Study group | Role | What they receive |
|---|---|---|
| SENSE Device Monitoring in ICH Patients | Experimental | The SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:
1. A molded plastic headpiece containing the antenna array, and
2. A processing control unit that contains:
1. The driving electronics for the array;
2. A spectrum analyzer coupled with a computer; and,
3. The operating software that controls the device function and data acquisition, processing and archiving.
For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam. Receives: Device: SENSE Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Serious Device-related Adverse Events
Number of subjects who experienced a serious device-related adverse event or seizure.
Measured: Up to 6 Weeks
Number of Patients Correctly Identified by SENSE With Hemorrhage Expansion (HE) or no Hemorrhage Expansion (NHE) Within 12 Hours.
The SENSE device continuously monitored patients for hemorrhage expansion (HE) defined as a greater than 3 ml increase in ICH volume. ICH volumes were determined from the CT scans by a neuroradiologist. The concordance of SENSE determination of HE or NHE with the CT results was determined.
Measured: 12 Hours
Secondary outcomes (1)
Feasibility of the SENSE Device in a Clinical Environment
Number of patients where data was successfully acquired, downloaded, and analyzed.
Measured: Up to 72 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2017 (estimated)
- Study start23 Feb 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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 Intracerebral 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sense Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William Knight, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03038087
- Sponsor's protocol ID
- SENSE-001
- Status last verified
- Dec 2021
- First submitted
- 19 Jan 2017
- Last updated
- 7 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Feasibility Study to Evaluate the User Interfaces and Sensitivity of the SENSE Device in Patients With Intracranial Hemorrhage
- ClinicalTrials.gov ID
- NCT03038087
- Acronym / sponsor ID
- SENSE-001
- Conditions
- Intracerebral Hemorrhage, Stroke, Acute, Stroke Hemorrhagic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Sense Diagnostics, LLCIndustry (pharma, biotech, devices)
- Study start
- 23 Feb 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 31 Jan 2017 (estimated)
- Results
- Posted 1 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to find out whether a device for monitoring bleeding in patients with acute hemorrhagic stroke will show similar findings as CT scans performed to evaluate the stroke.
Detailed description
This will be a prospective, observational, single site, first-in-man study of the SENSE device in up to 10 study subjects with primary spontaneous ICH. The treating clinicians will be blinded to the data collection and SENSE device scanning as described below.
All eligible subjects must have the diagnostic head CT scan (CT) demonstrating hemorrhage performed within 6 hours of symptom onset. While ICH and TBI patients may be evaluated in future studies, this early feasibility study is limited to primary spontaneous ICH patients only, given the relative homogeneity of this population compared with the TBI population.
Eligible subjects or legally authorized representatives will be approached for enrollment. After obtaining informed consent to participate in the study, a baseline study head CT will be performed to establish the hemorrhage volume; and the SENSE device will be placed on the subject within 15 minutes of this CT, or as soon as practicable, for initiation of monitoring. This repeat CT (after the diagnostic CT) is necessary since hemorrhage expansion (HE) occurs early in the clinical course, and the hemorrhage volume may have changed between the diagnostic CT and placement of the SENSE monitor.
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 to evaluate for HE will be performed at 12 (±6) hours after the baseline study head CT. Finally, a study head CT will be performed at 72 (±12) hours to evaluate cerebral edema. Any head CT performed for clinical deterioration as standard of care between the baseline and 72 hour study CTs will also be collected and analyzed.
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 testing. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. If the SENSE device is removed to perform the CT or SENSE monitoring is temporarily suspended, the SENSE device will be replaced; and SENSE monitoring will resume within 15 minutes, or as soon as practicable, after each CT scan. A SENSE measurement obtained within 15 minutes of each CT scan, or as soon as practicable thereafter, will be used for comparison with data analysis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SENSE Device Monitoring in ICH Patients | Experimental | Device: SENSE DeviceThe SENSE device transmits a low power tailored electro-magnetic (EM) pulse in the radio-frequency range across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts: 1. A molded plastic headpiece containing the antenna array, and 2. A processing control unit that contains: 1. The driving electronics for the array; 2. A spectrum analyzer coupled with a computer; and, 3. The operating software that controls the device function and data acquisition, processing and archiving. For this study, the research personnel will place the headset over the subject's head. The headset will be sized to fit snuggly. Each headset is marked with a unique headset identification number. The patient-contacting components of the molded plastic form are made from a medical grade (USP Class VI), biocompatible plastic and foam. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female patients age 22 years and older
- Diagnostic head CT scan within 24 hours of primary spontaneous ICH symptom onset
- ICH >3mL and <90mL, as measured by the ABC method
- 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 schedule for study procedures
Key exclusion criteria (12 listed)
- Female patients who are pregnant or lactating
- Patients with any history of seizure or 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
- Any intraventricular hemorrhage on the diagnostic (pre-enrollment) CT with planned placement of an intraventricular catheter
- 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 DeviceThe SENSE device transmits a low power tailored electro-magnetic pulse across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts: 1. A molded plastic headpiece containing the antenna array, and 2. A processing control unit. The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device. | Device | SENSE Device Monitoring in ICH Patients |
Primary outcome
Number of Patients With Serious Device-related Adverse Events
Time frame: Up to 6 Weeks
Number of subjects who experienced a serious device-related adverse event or seizure.
Number of Patients Correctly Identified by SENSE With Hemorrhage Expansion (HE) or no Hemorrhage Expansion (NHE) Within 12 Hours.
Time frame: 12 Hours
The SENSE device continuously monitored patients for hemorrhage expansion (HE) defined as a greater than 3 ml increase in ICH volume. ICH volumes were determined from the CT scans by a neuroradiologist. The concordance of SENSE determination of HE or NHE with the CT results was determined.
1 secondary outcome
Feasibility of the SENSE Device in a Clinical Environment
Time frame: Up to 72 Hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
William Knight, MD principal investigator
University of Cincinnati
1 site 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 Intracerebral Hemorrhage and Stroke, Acute, run by Sense Diagnostics, LLC at 1 site 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 12 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 7 Dec 2021. 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 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 1 Oct 2021). 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 Patients With Serious Device-related Adverse Events (time frame: Up to 6 Weeks). The study lists 2 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 7 Dec 2021.