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

Part of paid clinical trials in Gainesville, Florida.

Sponsor
Sense Diagnostics, LLC
Study ID
NCT06828107
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • SENSE device — 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 Details

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.

Key Dates

Start date
Jul 11, 2025
Status verified
Nov 2025
Primary completion
May 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: TBI patients with intracranial bleeding
    50 patients with TBI with intracranial bleeding
  • Arm: TBI patients without intracranial bleeding
    50 patients with TBI without intracranial bleeding
  • Arm: Control subjects with normal brain health
    50 control subjects with normal brain health

Primary Outcome Measure

Primary Efficacy Endpoint [ Time Frame: 12 months ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
University of FloridaGainesvilleFlorida32611
Hector Meza Comparan, MD
[email protected]
352-273-5550
Pouya Ameli, MD (PRINCIPAL_INVESTIGATOR)
University of CincinnatiCincinnatiOhio45209
Jason McMullan, MD
[email protected]
513-558-5281
Jason McMullan, MD (PRINCIPAL_INVESTIGATOR)
University of PittsburghPittsburghPennsylvania15260
Evan Gu
[email protected]
412-735-8498
David Barton, MD (PRINCIPAL_INVESTIGATOR)
MUSCCharlestonSouth Carolina29425
Paige Hall
[email protected]
843-792-7944
UT HoustonHoustonTexas77030
Arun Kane
[email protected]
713-500-7813
UTSASan AntonioTexas78249
Martha De La Mora
[email protected]
210-450-7956

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University of Florida· Gainesville, FLUniversity of Cincinnati· Cincinnati, OHUniversity of Pittsburgh· Pittsburgh, PAMUSC· Charleston, SCUT Houston· Houston, TXUTSA· San Antonio, TX

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