Ischemic Stroke Clinical Trial
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
NCT number | NCT03827720 |
Other study ID # | SENSE-002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 6, 2019 |
Est. completion date | January 4, 2021 |
Verified date | July 2021 |
Source | Sense Diagnostics, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 4, 2021 |
Est. primary completion date | November 19, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years and older |
Eligibility | Inclusion Criteria: 1. Male or female patients age 22 years and older 2. Established diagnosis of AIS (with or without LVO) or ICH within 24 hours of symptom onset 3. Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian 4. Willingness and ability to comply with 45 minutes of SENSE monitoring per study procedures 5. Attending (Treating) physician has indicated that the patient is stable and has approved the patient's participation in the study Exclusion Criteria: 1. Female patients who are pregnant or lactating 2. Patients with a known seizure disorder or those who have a seizure at stroke onset 3. 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 4. Intraventricular hemorrhage requiring emergent ventriculostomy placement on the eligibility CT or MRI 5. Secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis, trauma) 6. Pontine or infratentorial location of ICH 7. In AIS patients, treatment with intravenous alteplase and/or mechanical thrombectomy prior to the initiation of 45 minutes of SENSE monitoring 8. Current participation in an interventional clinical trial |
Country | Name | City | State |
---|---|---|---|
United States | TriHealth Hatton Research Institute - Good Samaritan Hospital | Cincinnati | Ohio |
United States | UC Health | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Sense Diagnostics, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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.. | 45 minutes | |
Secondary | 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. | 45 minutes | |
Secondary | 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. | 7 days |
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