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A Study to Evaluate the SENSE Device's Ability to Detect TBI

NCT06828107

This study is recruiting at 6 US sites in 5 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Traumatic Brain Injury

Eligibility basics and study details

Study type
Observational
Phase
Not applicable
Ages
22 years and older
Sex
All
Healthy volunteers
Accepted
Sponsor
Sense Diagnostics, LLC
Last updated on ClinicalTrials.gov
November 25, 2025

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Florida · 1

  • University of Florida · Gainesville, FL

Ohio · 1

  • University of Cincinnati · Cincinnati, OH

Pennsylvania · 1

  • University of Pittsburgh · Pittsburgh, PA

South Carolina · 1

  • MUSC · Charleston, SC

Texas · 2

  • UT Houston · Houston, TX
  • UTSA · San Antonio, TX

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.