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Biomarkers of Traumatic Brain Injury With Tbit System

NCT04107662 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 740

Last updated 2024-04-05

No results posted yet for this study

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).

Conditions

  • Brain Injuries, Traumatic

Interventions

DEVICE

Tbit system

Suspected traumatic brain injury with head CT

Sponsors & Collaborators

  • BioDirection Inc

    lead INDUSTRY

Principal Investigators

  • Jerika Acosta, BSc · Medicept Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-01
Primary Completion
2025-05-30
Completion
2025-05-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04107662 on ClinicalTrials.gov