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

March 17, 2025 updated by: The Geneva Foundation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Ft. Sam Houston, Texas, United States, 78234
        • Brooke Army Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Intracranial Hemorrhage
Intracranial hemorrhage categories may include subdural hematomas, subarachnoid hemorrhages, or intraparenchymal hemorrhages.
Device: 3D Transcranial Ultrasound Brain Imaging
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
Epidural hematoma group will be additionally tested to explore feasibility of scanning to this higher-acuity injury type
Device: 3D Transcranial Ultrasound Brain Imaging
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From enrollment to the end of data analysis (18 months)
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.
up to 48 hours after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
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.
From enrollment to discharge of subject (7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Geneva Foundation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Uniformed Services University of the Health Sciences
Brooke Army Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 4, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • C.2025.005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

To minimize risk of breaching confidentiality, individual data will not be shared with other researchers. Aggregate data may be shared upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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