Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT06780436

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

Sponsor: The Geneva Foundation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 89 Years

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2024-12-04

Completion Date

2026-09

Last Updated

2025-03-20

Healthy Volunteers

No

Interventions

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.

Locations (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, United States