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

NCT05155800 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2023-11-22

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

SDx3

The SENSE Device (SDx3) is a non-invasive device that detects differences in the absorption of transmitted RF energy across the skull and brain and is intended to be used to evaluate intracranial hemorrhage.

Sponsors & Collaborators

  • Sense Diagnostics, LLC

    lead INDUSTRY

Principal Investigators

  • Jonathan Ratcliff, MD · Emory University

Eligibility

Min Age
22 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-28
Primary Completion
2023-10-17
Completion
2023-11-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05155800 on ClinicalTrials.gov