Traumatic Brain Hemorrhage3D-TRUBINCT06780436
3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages
An observational study of Traumatic Brain Hemorrhage and Traumatic Brain Injury, run by The Geneva Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Traumatic Brain Hemorrhage, Traumatic Brain Injury, Intracranial Hemorrhages
- What is being tested?
- 3D Transcranial Ultrasound Brain Imaging
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2024to Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from qualifying Traumatic Brain Injuries accepted for care at Brooke Army Medical Center
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234
About this study
Official title: 3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages Caused by Traumatic Brain Injuries
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.
Read the 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.
- Conditions
- Traumatic Brain Hemorrhage, Traumatic Brain Injury, Intracranial Hemorrhages, Ultrasound Exams, 3D SONOGRAPHY
- Being tested
- 3D Transcranial Ultrasound Brain Imaging
- Keywords
- transcranial ultrasound, traumatic brain injury, intracranial hemorrhage, ultrasound
- Medical subject headings
- Brain Hemorrhage, Traumatic, Brain Injuries, Traumatic, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D Transcranial Ultrasound Brain ImagingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intracranial Hemorrhage | Intracranial hemorrhage categories may include subdural hematomas, subarachnoid hemorrhages, or intraparenchymal hemorrhages. Receives: 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 Receives: Device: 3D Transcranial Ultrasound Brain Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 48 hours after enrollment
Secondary outcomes (2)
Morphometric comparison of 3D-TRUBI with Standard Radiology
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.
Measured: From enrollment to end of data analysis (18 months)
Feasibility of 3D-TRUBI Assessment for Detection of Intracranial Hemorrhage
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.
Measured: From enrollment to discharge of subject (7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start4 Dec 2024
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Geneva Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Brooke Army Medical Center, Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780436
- Sponsor's protocol ID
- C.2025.005
- Acronym
- 3D-TRUBI
- Status last verified
- Mar 2025
- First submitted
- 13 Jan 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: To minimize risk of breaching confidentiality, individual data will not be shared with other researchers. Aggregate data may be shared upon reasonable request.
Publications
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
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.
PubMed 23363729
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Transcranial Ultrasound Brain Imaging (3D-TRUBI) Instrument for Point-of-Care Diagnosis of Intracranial Hemorrhages Caused by Traumatic Brain Injuries
- ClinicalTrials.gov ID
- NCT06780436
- Acronym / sponsor ID
- 3D-TRUBI / C.2025.005
- Conditions
- Traumatic Brain Hemorrhage, Traumatic Brain Injury, Intracranial Hemorrhages, Ultrasound Exams, 3D SONOGRAPHY
- Keywords
- transcranial ultrasound, traumatic brain injury, intracranial hemorrhage, ultrasound
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Geneva FoundationUniversity, hospital or other
- Collaborators
- Brooke Army Medical Center, Uniformed Services University of the Health Sciences
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracranial Hemorrhage | – | Device: 3D Transcranial Ultrasound Brain ImagingIntracranial hemorrhage categories may include subdural hematomas, subarachnoid hemorrhages, or intraparenchymal hemorrhages. |
| Epidural Hematoma | – | Device: 3D Transcranial Ultrasound Brain ImagingEpidural hematoma group will be additionally tested to explore feasibility of scanning to this higher-acuity injury type |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from qualifying Traumatic Brain Injuries accepted for care at Brooke Army Medical Center
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D Transcranial Ultrasound Brain ImagingThe 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. | Device | Epidural Hematoma, Intracranial Hemorrhage |
Primary outcome
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.
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.
2 secondary outcomes
Morphometric comparison of 3D-TRUBI with Standard Radiology
Time frame: From enrollment to end of data analysis (18 months)
Feasibility of 3D-TRUBI Assessment for Detection of Intracranial Hemorrhage
Time frame: From enrollment to discharge of subject (7 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- BackgroundE.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
- BackgroundD.R.Gr. Maev, K. Shapoori, E.V. Malyarenko, "An ultrasonic adaptive beamforming method and its application for transcranial imaging", US20160187473A1, June 25, 2019
- BackgroundC.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
- BackgroundB.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: PubMed 23363729Wydra 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.
- Individual participant dataSharing planned: No. To minimize risk of breaching confidentiality, individual data will not be shared with other researchers. Aggregate data may be shared upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Hemorrhage and Traumatic Brain Injury, run by The Geneva Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intracranial Hemorrhage Detection (time frame: From enrollment to the end of data analysis (18 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06780436, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.