NCT05155800

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 75 (actual)
• Sponsor: Sense Diagnostics, LLC · Industry
• Sex: All
• Age: 22 Years – 50 Years
• Healthy volunteers: Accepted

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

• Traumatic Brain Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-12-28
• Primary completion: 2023-10-17
• Completion: 2023-11-15
• First posted: 2021-12-14
• Last updated: 2023-11-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study