Brain Injuries, TraumaticMOBI-1NCT04893837
Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)
An observational study of Brain Injuries, Traumatic, run by University of Alabama at Birmingham at 2 sites in United States.
Trial summary
MOBI-1 is a multicenter clinical trial that will evaluate the use of the Infrascanner for the monitoring of traumatic intracranial hematomas. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Brain Injuries, Traumatic
- Type of treatment
- Medical device
- How many people
- 399 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Apr 2022to 25 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will enroll up to 440 patients over 14 months, at 10 trauma centers. Currently, there are no high quality published datasets or literature to document the mean or variability in time to the detection of hematoma expansion that could be used for meaningful sample size projections. Therefore, this study has been designed to provide reasonable estimates of the future study outcomes.
Who may be able to join
- Age 15 or older
- Admission CT Scan shows intracranial hemorrhage
- Glasgow Coma Scale less than 15
- Neurosurgery service determines initial care is nonoperative
- Admitted for observation for TBI, to either step-down unit or intensive care unit
Who cannot join
- Inability to provide informed consent or lack of a legally authorized representative (LAR)
- Admitted and observed for >2 hours prior to screening (i.e., has already received second neurological check)
- Other injuries deemed non-survivable
- Diagnosed with hemorrhagic shock or receives a large volume transfusion (>3 units of any blood product within any 1 hour)
- Planned surgical interventions/ procedures during study period (before the second CT scan)
- Known prisoner
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UAB Hospital
Birmingham, Alabama, 35233
University of Arizona
Tucson, Arizona, 85724
About this study
MOBI-1 is a multicenter clinical trial that will evaluate the use of the Infrascanner for the monitoring of traumatic intracranial hematomas.
Read the detailed description
MOBI-1 is a single-arm, multi-center derivation / validation study that will evaluate the use of the Infrascanner for monitoring traumatic intracranial hematomas. All patients will receive standard care plus hourly infrascanner assessments. This study will test the hypotheses that:
- The Infrascanner has sufficient diagnostic performance to detect the expansion of intracranial hematomas
- Patients who have expanding intracranial hematomas will be identified faster when monitored with hourly infrascanner assessments compared to standard care alone
- Clinical / research staff will be able to attain all data points and relay the assessments to the medical team.
- Conditions
- Brain Injuries, Traumatic
- Being tested
- Standard care plus infrascans
- Keywords
- traumatic brain injury, TBI, intracranial hematoma, ICH
- Medical subject headings
- Brain Injuries, Traumatic, Hepatitis, Infectious Canine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care plus infrascansDevice
Hourly infrascans to detect expanding intracranial hematomas
| Study group | Role | What they receive |
|---|---|---|
| Standard care plus infrascans | All participants will receive regular clinical neurological assessments as ordered by the clinical care team. In addition, a research team member will perform an infrascan. This process will be repeated hourly at the same timepoint as the clinical neurological assessments. If a patient's neurological status deteriorates at any time point, and the medical team orders an early (unplanned) CT scan, the neurological data collection will cease once the patient is sent to CT.
Infrascan results will not be shared with the clinical care team, and will not guide the participants' care in any way. Receives: Device: Standard care plus infrascans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of the infrascanner
Number of participants whose Infrascan results were accurate
Measured: Month 24
Secondary outcomes (1)
Time to detection of an enlarging hematoma
Difference in time to detection of hematoma enlargement between Infrascan and second CT across the cohort
Measured: 0-12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start18 Apr 2022
- Primary completion17 Jun 2025
- Study completion25 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injuries, TraumaticStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, InfraScan, Inc.
- Responsible party
- Principal investigator, Jan O. Jansen, University of Alabama at Birmingham
- Investigators
- Jan O Jansen, MBBS, PhD, Principal investigator, University of Alabama at Birmingham, Center for Injury Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893837
- Sponsor's protocol ID
- IRB-300007257
- Other IDs
- 20-15-TBI-008
- Acronym
- MOBI-1
- Status last verified
- Aug 2025
- First submitted
- 14 May 2021
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: This data will be uploaded to the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system, as a requirement of the funding agency. Only de-identified data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)
- ClinicalTrials.gov ID
- NCT04893837
- Acronym / sponsor ID
- MOBI-1 / IRB-300007257
- Conditions
- Brain Injuries, Traumatic
- Keywords
- traumatic brain injury, TBI, intracranial hematoma, ICH
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- United States Department of Defense, InfraScan, Inc.
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 25 Aug 2025 (actual)
- First posted
- 20 May 2021 (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.
MOBI-1 is a multicenter clinical trial that will evaluate the use of the Infrascanner for the monitoring of traumatic intracranial hematomas.
Detailed description
MOBI-1 is a single-arm, multi-center derivation / validation study that will evaluate the use of the Infrascanner for monitoring traumatic intracranial hematomas. All patients will receive standard care plus hourly infrascanner assessments. This study will test the hypotheses that:
- The Infrascanner has sufficient diagnostic performance to detect the expansion of intracranial hematomas
- Patients who have expanding intracranial hematomas will be identified faster when monitored with hourly infrascanner assessments compared to standard care alone
- Clinical / research staff will be able to attain all data points and relay the assessments to the medical team.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standard care plus infrascans | – | Device: Standard care plus infrascansAll participants will receive regular clinical neurological assessments as ordered by the clinical care team. In addition, a research team member will perform an infrascan. This process will be repeated hourly at the same timepoint as the clinical neurological assessments. If a patient's neurological status deteriorates at any time point, and the medical team orders an early (unplanned) CT scan, the neurological data collection will cease once the patient is sent to CT. Infrascan results will not be shared with the clinical care team, and will not guide the participants' care in any way. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will enroll up to 440 patients over 14 months, at 10 trauma centers. Currently, there are no high quality published datasets or literature to document the mean or variability in time to the detection of hematoma expansion that could be used for meaningful sample size projections. Therefore, this study has been designed to provide reasonable estimates of the future study outcomes.
Key inclusion criteria (5 listed)
- Age 15 or older
- Admission CT Scan shows intracranial hemorrhage
- Glasgow Coma Scale less than 15
- Neurosurgery service determines initial care is nonoperative
- Admitted for observation for TBI, to either step-down unit or intensive care unit
Key exclusion criteria (6 listed)
- Inability to provide informed consent or lack of a legally authorized representative (LAR)
- Admitted and observed for >2 hours prior to screening (i.e., has already received second neurological check)
- Other injuries deemed non-survivable
- Diagnosed with hemorrhagic shock or receives a large volume transfusion (>3 units of any blood product within any 1 hour)
- Planned surgical interventions/ procedures during study period (before the second CT scan)
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 |
|---|---|---|
| Standard care plus infrascansHourly infrascans to detect expanding intracranial hematomas | Device | Standard care plus infrascans |
Primary outcome
Diagnostic performance of the infrascanner
Time frame: Month 24
Number of participants whose Infrascan results were accurate
1 secondary outcome
Time to detection of an enlarging hematoma
Time frame: 0-12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: Yes. This data will be uploaded to the Federal Interagency Traumatic Brain Injury Research (FITBIR) informatics system, as a requirement of the funding agency. Only de-identified data will be shared.
Related trials for Brain Injuries, Traumatic
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
RecruitingObservational study
Intracranial Pressure Monitoring in Moderate Traumatic Brain Injury
Moderate Traumatic Brain Injury
Not yet recruitingPhase 1
Nanopulse Laser Therapy
TBI (Traumatic Brain Injury)
RecruitingObservational study
Effect of Different Intravenous Fluids on Post-operative Chronic Subdural Hematoma Size and Recurrence
Chronic Subdural Hematoma
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.
Jan O Jansen, MBBS, PhD principal investigator
University of Alabama at Birmingham, Center for Injury Science
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Injuries, Traumatic, run by University of Alabama at Birmingham at 2 sites 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 6 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: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic performance of the infrascanner (time frame: Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Sep 2025.