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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

Interventions

DEVICE

Tbit system

Suspected traumatic brain injury with head CT