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NOT YET RECRUITING
NCT04107662
Biomarkers of Traumatic Brain Injury With Tbit System
Sponsor: BioDirection Inc
View on ClinicalTrials.gov
Summary
A prospective, multi-center, non-randomized, pivotal study to assess the safety and efficacy of the Tbit™ System to aid in patient evaluation, suspected of traumatic brain injury, as adjunct companion test to radiologic standard of care, Cranial Computerized Tomography (CCT).
Official title: A Prospective, Multi-Center, Non-Randomized Study to Identify Intracranial Hemorrhage by Using an In-Vitro Device, Tbit™ System
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
740
Start Date
2024-12-01
Completion Date
2025-05-30
Last Updated
2024-04-05
Healthy Volunteers
No
Conditions
Interventions
DEVICE
Tbit system
Suspected traumatic brain injury with head CT