A Study to Test the SENSE Device in Patients With Intracranial Hemorrhage

Stroke, Acute Clinical Trial

Official title: An Early Feasibility Study to Evaluate the User Interfaces and Sensitivity of the SENSE Device in Patients With Intracranial Hemorrhage

Status Completed

Clinical 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Hemorrhagic Stroke
• Intracerebral Hemorrhage
• Intracranial Hemorrhages
• Stroke
• Stroke Hemorrhagic
• Stroke, Acute

• NCT number: NCT03038087
• Study type: Interventional
• Source: Sense Diagnostics, LLC
• Status: Completed
• Phase: N/A
• Start date: February 23, 2017
• Completion date: December 31, 2017