Non-Invasive Monitoring of Traumatic Brain Injury Progres... | NCT04893837

Studies
Non-Invasive Monitoring of Traumatic Brain Injury Progression Using the Infrascanner (MOBI-1)

NCT04893837

Sponsor

University of Alabama at Birmingham

Status

Completed

Last Update Posted

Sep 2, 2025Actual

Enrollment

399Actual

Phase

Not provided

Conditions

Brain Injuries, Traumatic

Interventions

Standard care plus infrascans

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
20-15-TBI-008	Other Grant/Funding Number	MTEC

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 18, 2022Actual

Primary Completion Date

Jun 17, 2025Actual

Completion Date

Aug 25, 2025Actual

First Submitted Date

May 14, 2021

First Submission Date that Met QC Criteria

May 14, 2021

First Posted Date

May 20, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2025

Last Update Posted Date

Sep 2, 2025Actual

Name	Class
United States Department of Defense	FED
InfraScan, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

399Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.	Device: Standard care plus infrascans

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard care plus infrascans	Device	Hourly infrascans to detect expanding intracranial hematomas	Standard care plus infrascans

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Diagnostic performance of the infrascanner	Number of participants whose Infrascan results were accurate	Month 24

Secondary Outcomes

Measure	Description	Time Frame
Time to detection of an enlarging hematoma	Difference in time to detection of hematoma enlargement between Infrascan and second CT across the cohort	0-12 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan O Jansen, MBBS, PhD	University of Alabama at Birmingham, Center for Injury Science	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UAB Hospital		Birmingham	Alabama	35233	United States
University of Arizona

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Not provided

Time Frame

Data will be uploaded to FITBIR annually.

Access Criteria

Access is through the FITBIR system, per their requirements.

URL

https://fitbir.nih.gov/

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D006522	Hepatitis, Infectious Canine

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided