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RECRUITING
NCT06828107

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

Sponsor: Sense Diagnostics, LLC

View on ClinicalTrials.gov

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

Interventions

DEVICE

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