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

Active, not recruiting

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

• Registration Number: NCT06780436
• Lead Sponsor: The Geneva Foundation

Brief 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.

Study Timeline

• Study Start: 2024-12-04
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-13
• Study First Posted: 2025-01-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-20
• Primary Completion: 2026-08
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of Intracranial Hemorrhage Detection	From enrollment to the end of data analysis (18 months)	The primary outcome is the assessment of the feasibility of 3D-TRUBI for the detection of ICH and other traumatic brain lesions as compared to admission head CT. This is a binary parameter for each type of lesion per patient.
Evaluation of potential adverse effects	up to 48 hours after enrollment	Participants will be evaluated for any potential adverse reactions to performance of the TRUBI exam during and after the research procedure. Twenty-four and 48-hour examination of the head are also planned to record potential adverse reactions.

Secondary Outcome Measures

Name	Time	Method
Feasibility of 3D-TRUBI Assessment for Detection of Intracranial Hemorrhage	From enrollment to discharge of subject (7 days)	To address feasibility of deployment of the 3D-TRUBI for ICH detection in the acute care setting, we will collect and analyze the time required to recruit, enroll, initiate, complete, and (where appropriate) repeat the assessment for ICH detection.
Morphometric comparison of 3D-TRUBI with Standard Radiology	From enrollment to end of data analysis (18 months)	If the ICH lesion is detectable on CT, the conventional morphometric analysis of the lesion (maximum thickness, width, and length) and midline shift will be compared with morphometric analysis of the same lesions on 3D-TRUBI images. Measurements of ICH lesions by both modalities will be done in mm (millimeters), so there will be direct numerical comparisons of results using descriptive statistics, and other types of correlation and regression analyses.

Trial Locations

Locations (1)

Brooke Army Medical Center; 🇺🇸 Ft. Sam Houston, Texas, United States