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A Study to Test the SENSE Device in Military-Age Patients With Traumatic Brain Injury — Sense-005  

Traumatic Brain Injury Clinical Trial

Official title:
A Prospective, Non-Randomized, Sequentially Enrolled, Multi-Center, Phase II Study to Evaluate the SENSE Device's Ability to Detect and Monitor Traumatic Brain Injury

Clinical Trial 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 between the ages of 22 to 50 will be enrolled. All TBI patients must have a diagnostic head CT scan within 24 hours of the injury. TBI patients without intracranial bleeding based on the CT scan must have a Glasgow Coma Scale (GCS) score at enrollment of ≤ 14. Total maximum duration of active monitoring with the device in this study is 48 hours with a clinical follow-up at day 7 after enrollment.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05155800
Study type Observational
Source Sense Diagnostics, LLC
Contact
Status Completed
Phase
Start date December 28, 2021
Completion date November 15, 2023
View Details
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