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

NCT03038087 | Completed Results FDA Device

• 1 other identifier: SENSE-001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Intracerebral Hemorrhage; Stroke, Acute; Stroke Hemorrhagic

Outcome Measures

Primary Outcomes (2)

• Number of Patients With Serious Device-related Adverse Events

  Number of subjects who experienced a serious device-related adverse event or seizure.

  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.

  12 Hours

Secondary Outcomes (1)

• Feasibility of the SENSE Device in a Clinical Environment

  Up to 72 Hours

Study Arms (1)

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.

Device: SENSE Device

Interventions

SENSE Device DEVICE

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: 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.

SENSE Device Monitoring in ICH Patients

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Sense Diagnostics, LLC: lead

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

MeSH Terms

Conditions

Cerebral Hemorrhage; Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joe Korfhagen
• Organization: SENSE Diagnostics, Inc.

jkorfhagen@senseneuro.com

844-373-6730

Study Officials

• William Knight, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2017
• First Posted: January 31, 2017
• Study Start: February 23, 2017
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: December 7, 2021
• Results First Posted: October 1, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)