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

NCT06780436 | Active Not Recruiting FDA Device

• 1 other identifier: C.2025.005
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

transcranial ultrasound; traumatic brain injury; intracranial hemorrhage; ultrasound

Outcome Measures

Primary Outcomes (2)

• Feasibility of Intracranial Hemorrhage Detection

  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.

  From enrollment to the end of data analysis (18 months)

• Evaluation of potential adverse effects

  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.

  up to 48 hours after enrollment

Secondary Outcomes (2)

• Morphometric comparison of 3D-TRUBI with Standard Radiology

  From enrollment to end of data analysis (18 months)

• Feasibility of 3D-TRUBI Assessment for Detection of Intracranial Hemorrhage

  From enrollment to discharge of subject (7 days)

Study Arms (2)

Intracranial Hemorrhage

Intracranial hemorrhage categories may include subdural hematomas, subarachnoid hemorrhages, or intraparenchymal hemorrhages.

Device: 3D Transcranial Ultrasound Brain Imaging

Epidural Hematoma

Epidural hematoma group will be additionally tested to explore feasibility of scanning to this higher-acuity injury type

Device: 3D Transcranial Ultrasound Brain Imaging

Interventions

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.

Epidural Hematoma; Intracranial Hemorrhage

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from qualifying Traumatic Brain Injuries accepted for care at Brooke Army Medical Center

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Geneva Foundation: lead
• Brooke Army Medical Center: collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (5)

• E.R.Gr. Maev, K. Shapoori, E.V. Malyarenko, "An Ultrasonic Adaptive Beamforming Method and its Application for Transcranial Imaging", EP 3, 215, 868 B1, October 3, 2018

  BACKGROUND

• D.R.Gr. Maev, K. Shapoori, E.V. Malyarenko, "An ultrasonic adaptive beamforming method and its application for transcranial imaging", US20160187473A1, June 25, 2019

  BACKGROUND

• C.J. Sadler, R.Gr. Maev, E. Malyarenko, "A System to Obtain 3D Images of a Flowing Region Beneath an object using Speckle Reflections", US 9, 842, 384, December 12, 2017

  BACKGROUND

• B.J. Sadler, R.Gr. Maev, E. Malyarenko, "A Method to Obtain 3D Images of a Flowing Region Beneath an object using Speckle Reflections", US 9, 613, 401, April 4, 2017

  BACKGROUND

• Wydra A, Malyarenko E, Shapoori K, Maev RG. Development of a practical ultrasonic approach for simultaneous measurement of the thickness and the sound speed in human skull bones: a laboratory phantom study. Phys Med Biol. 2013 Feb 21;58(4):1083-102. doi: 10.1088/0031-9155/58/4/1083. Epub 2013 Jan 31.

  PMID: 23363729 BACKGROUND

MeSH Terms

Conditions

Brain Hemorrhage, Traumatic; Brain Injuries, Traumatic; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhage, Traumatic; Cerebrovascular Disorders; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: December 4, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)