NCT06780436|Active Not RecruitingFDA Device
3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages
3D-TRUBI
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3D-TRUBI
Sponsor study identifier
observational
20
1 country
1
Study Start
December 4, 2024
Actual (reported)Primary Completion
August 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 4, 2024
Actual (reported)January 13, 2025
Actual (reported)January 17, 2025
Actual (reported)August 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Intracranial hemorrhage categories may include subdural hematomas, subarachnoid hemorrhages, or intraparenchymal hemorrhages.
Epidural hematoma group will be additionally tested to explore feasibility of scanning to this higher-acuity injury type
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Participants will be recruited from qualifying Traumatic Brain Injuries accepted for care at Brooke Army Medical Center
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234, United States
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
D.R.Gr. Maev, K. Shapoori, E.V. Malyarenko, "An ultrasonic adaptive beamforming method and its application for transcranial imaging", US20160187473A1, June 25, 2019
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
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
First Submitted
January 13, 2025
First Posted
January 17, 2025
Study Start
December 4, 2024
Actual (reported)Primary Completion
August 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
A Study to Evaluate the SENSE Device's Ability to Detect TBI
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)
Contact the study team to confirm eligibility.
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.
Study Completion
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 20, 2025
Record last verified: 2025-03
To minimize risk of breaching confidentiality, individual data will not be shared with other researchers. Aggregate data may be shared upon reasonable request.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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