BioDirection Inc
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).
Brain Injuries, Traumatic
Tbit system
Study Type : | OBSERVATIONAL |
Estimated Enrollment : | 740 participants |
Official Title : | A Prospective, Multi-Center, Non-Randomized Study to Identify Intracranial Hemorrhage by Using an In-Vitro Device, Tbit™ System |
Actual Study Start Date : | 2024-12-01 |
Estimated Primary Completion Date : | 2025-05-30 |
Estimated Study Completion Date : | 2025-05-30 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
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