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Active, Not Recruiting

NCT Number: NCT06780436

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Traumatic Brain Hemorrhage 3D SONOGRAPHY Brain Diseases Brain Hemorrhage, Traumatic Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Intracranial Hemorrhage, Traumatic Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Traumatic Brain Injury Ultrasound Exams Vascular Diseases Wounds and Injuries

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D Transcranial Ultrasound Brain Imaging

Device

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.

Primary outcomes

  1. Feasibility of Intracranial Hemorrhage Detection

    Time frame: 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.

  2. Evaluation of potential adverse effects

    Time frame: 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 outcomes

  1. Morphometric comparison of 3D-TRUBI with Standard Radiology

    Time frame: 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.

  2. Feasibility of 3D-TRUBI Assessment for Detection of Intracranial Hemorrhage

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Geneva Foundation

Other

Collaborators

  • Brooke Army Medical Center
  • Uniformed Services University of the Health Sciences

Registry information

Official study title

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

Acronym: 3D-TRUBI

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 17, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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