Clinical Research Directory
Browse clinical research sites, groups, and studies.
A Study to Evaluate the SENSE Device's Ability to Detect TBI
Sponsor: Sense Diagnostics, LLC
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.
Official title: A Prospective, Non-randomized, Sequentially-enrolled, Multi-center, Phase II Study to Evaluate the SENSE Device's Ability to Detect Traumatic Brain Injury
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
OBSERVATIONAL
Enrollment
150
Start Date
2025-07-11
Completion Date
2026-06-30
Last Updated
2025-11-25
Healthy Volunteers
Yes
Conditions
Interventions
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.
Locations (6)
University of Florida
Gainesville, Florida, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
MUSC
Charleston, South Carolina, United States
UT Houston
Houston, Texas, United States
UTSA
San Antonio, Texas, United States