NCT06780436

3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages

3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages Caused by Traumatic Brain Injuries

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: The Geneva Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to assess the safety of the 3D Transcranial Ultrasound Brain Imaging (3D TRUBI) device in Traumatic Brain Injury (TBI) patients with intracranial hemorrhage (ICH). The secondary objective is to assess the diagnostic potential of 3D TRUBI. The latter will be achieved by comparison of 3D TRUBI scans with admission head computed tomography (CT), the standard of care diagnostic modality. Demonstrating the feasibility and safety of the 3D TRUBI system is the first step toward expanding access of an alternative to CT for diagnostic imaging and triage of mass casualties of war or natural disasters in the field and in rapidly deployed medical centers or other austere environments.

Detailed description

Eligible participants positive for intracranial hemorrhage (ICH) due to traumatic brain injury (TBI) will undergo a full scanning procedure by trained investigators. Examination with the 3D TRUBI system will involve acquisition of 16 pre-defined bilateral head points. The total time to complete the procedure is approximately 20 minutes. During the examination, feasibility and safety metrics will be collected. Additional injury data will be reviewed from participants' electronic medical record. The goal of the study is 1) to evaluate the safety of the 3D TRUBI device in the target population and 2) do demonstrate the feasibility of the device to detect ICH compared to standard medical imaging.

Conditions

• Traumatic Brain Hemorrhage
• Traumatic Brain Injury
• Intracranial Hemorrhages
• Ultrasound Exams
• 3D SONOGRAPHY

Interventions

Type	Name	Description
DEVICE	3D Transcranial Ultrasound Brain Imaging	The system implements a proprietary transcranial imaging methodology, which measures the profile of the skull bone and the speed of sound in it to accurately focus the ultrasound energy from a phased array probe through the bone in order to detect hematoma boundaries with resolution normally obtainable only through the open skull.

Timeline

• Start date: 2024-12-04
• Primary completion: 2026-08-01
• Completion: 2026-09-01
• First posted: 2025-01-17
• Last updated: 2025-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study