A Study to Evaluate the SENSE Device's Ability to Detect TBI
Condition(s) studied
Investigational drug(s) / intervention(s)
SENSE device: 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 and/or cerebral edema.
Study summary
The study population will consist of 3 mutually-exclusive sets of patients and subjects:
* TBI patients with intracranial bleeding
* TBI patients without intracranial bleeding
* Control subjects with normal brain health.
Research subjects ages 22 and older will be enrolled. All TBI patients must be monitored with the SENSE Device within 6 hours of a diagnostic head CT scan ordered by a treating clinician and within 24 hours of injury.
Eligibility
Primary outcome measure(s)
- Primary Efficacy Endpoint — 12 months
The SENSE output for each patient will be classified as showing intracranial hemorrhage or no intracranial hemorrhage for each study CT with corresponding SENSE data. The SENSE output will be compared with the gold standard (CT scan result) to determine the accuracy of the SENSE Device as classifying TBI patients with and without intracranial hemorrhage correctly.
Trial sites (6)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Florida | Gainesville | Florida | Recruiting |
| University of Cincinnati | Cincinnati | Ohio | Recruiting |
| University of Pittsburgh | Pittsburgh | Pennsylvania | Recruiting |
| MUSC | Charleston | South Carolina | Recruiting |
| UT Houston | Houston | Texas | Recruiting |
| UTSA | San Antonio | Texas | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06828107 on ClinicalTrials.gov ↗ ← All trials in the USA