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

The Geneva Foundation

Status

Active, not recruiting

Conditions

Traumatic Brain Hemorrhage

Ultrasound Exams

Traumatic Brain Injury

3D SONOGRAPHY

Intracranial Hemorrhages

Treatments

Device: 3D Transcranial Ultrasound Brain Imaging

Study type

Observational

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT06780436

C.2025.005

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 89 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 18-89
Acute head injury with CT-confirmed intracranial hemorrhage
Able to obtain written, informed consent from participant or legally authorized representative
Able to receive intervention within 4 hours of admission head CT
Able to feasibly receive intervention prior to neurosurgical indication

Exclusion criteria

Did not receive routine head CT
Prisoner or Wards of State
Large or open skull wounds prohibiting ultrasound acquisition
Received large volume fluid resuscitation (e.g. >3 units of blood product) within 2 hours of intervention
Any prohibiting condition or contraindication for ultrasound image acquisition