Status:
COMPLETED
Early Feasibility Study of the SENSE Device
Lead Sponsor:
Sense Diagnostics, LLC
Conditions:
Hemorrhagic Stroke
Ischemic Stroke
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 st...
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 2...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 4 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03827720
Start Date
June 6 2019
End Date
January 4 2021
Last Update
July 2 2021
Active Locations (2)
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1
TriHealth Hatton Research Institute - Good Samaritan Hospital
Cincinnati, Ohio, United States, 45212
2
UC Health
Cincinnati, Ohio, United States, 45219