NCT04893837

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 399 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 15 Years
• Healthy volunteers: Not accepted

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: 1. The Infrascanner has sufficient diagnostic performance to detect the expansion of intracranial hematomas 2. Patients who have expanding intracranial hematomas will be identified faster when monitored with hourly infrascanner assessments compared to standard care alone 3. Clinical / research staff will be able to attain all data points and relay the assessments to the medical team.

Conditions

• Brain Injuries, Traumatic

Interventions

Type	Name	Description
DEVICE	Standard care plus infrascans	Hourly infrascans to detect expanding intracranial hematomas

Timeline

• Start date: 2022-04-18
• Primary completion: 2025-06-17
• Completion: 2025-08-25
• First posted: 2021-05-20
• Last updated: 2025-09-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study