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

NCT03038087 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-12-07

Study results available
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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

Interventions

DEVICE

SENSE 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.

Sponsors & Collaborators

  • Sense Diagnostics, LLC

    lead INDUSTRY

Principal Investigators

  • William Knight, MD · University of Cincinnati

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-23
Primary Completion
2017-12-31
Completion
2017-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03038087 on ClinicalTrials.gov