Clinical trial NCT03038087: A Study to Test the SENSE Device in Patients With Intracranial Hemorrhage
Official title: An Early Feasibility Study to Evaluate the User Interfaces and Sensitivity of the SENSE Device in Patients With Intracranial Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracerebral Hemorrhage
Stroke, Acute
Stroke Hemorrhagic
Lead sponsor: Sense Diagnostics, LLC
Sponsor class: INDUSTRY
First posted: 2017-01-31
Enrollment: 10
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients age 22 years and older
2. Diagnostic head CT scan within 24 hours of primary spontaneous ICH symptom onset
3. ICH \>3mL and \<90mL, as measured by the ABC method
4. Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian
5. Willingness and ability to comply with schedule for study procedures

Exclusion Criteria:

1. Female patients who are pregnant or lactating
2. Patients with any history of seizure or 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. Any intraventricular hemorrhage on the diagnostic (pre-enrollment) CT with planned placement of an intraventricular catheter
5. Secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis, trauma)
6. Planned withdrawal of care within 24 hours of enrollment
7. Planned surgical evacuation within 24 hours of enrollment
8. Current participation in a medical or surgical interventional clinical trial
9. Presence of subdural, epidural or aneurysmal subarachnoid hemorrhage on diagnostic scan
10. 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
11. Planned continued use of medications that, in the investigator's best clinical judgment, could increase the chances for subsequent uncontrolled hemorrhage
12. Planned or current use of continuous EEG monitoring

Primary outcomes:
measure: Number of Patients With Serious Device-related Adverse Events
timeFrame: Up to 6 Weeks
measure: Number of Patients Correctly Identified by SENSE With Hemorrhage Expansion (HE) or no Hemorrhage Expansion (NHE) Within 12 Hours.
timeFrame: 12 Hours
Secondary outcomes:
measure: Feasibility of the SENSE Device in a Clinical Environment
timeFrame: Up to 72 Hours
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: William Knight, MD
role: PRINCIPAL_INVESTIGATOR
References: