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Evaluate the SENSE Device's Ability to Monitor and Detect Intracranial Hemorrhage

Testing the SENSE Device for brain bleed detection and monitoring.

Recruiting
22 years and older
All
Phase N/A

This study aims to test the SENSE device for spotting brain bleeding, or intracranial hemorrhage (ICH). A CT scan (a special X-ray of the head) is the usual way to find ICH. The study compares the SENSE device with these CT scans. In the first part of the study, 150 people with ICH helped create a special tool, called an algorithm, to detect ICH. Now, in the second part, this tool will be tested on up to 300 new people. Doctors will not know the SENSE device results to ensure fair testing. People can join if they are 22 or older and have had a CT scan at a hospital or emergency room. They cannot join if they have certain metal objects in their head or have had certain treatments.

  • The study needs about 300 participants and compares two methods of detecting ICH.
  • Participants must have a CT scan and meet certain health conditions.
  • The SENSE device is being tested alongside traditional CT scans for accuracy.
Study details
    Intracranial Hemorrhages
    Traumatic Brain Injury

NCT04642443

Sense Diagnostics, LLC

13 December 2024

Step 1 Get in touch with the nearest study center
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