Trials / Not Yet Recruiting
Not Yet RecruitingNCT04107662
Biomarkers of Traumatic Brain Injury With Tbit System
A Prospective, Multi-Center, Non-Randomized Study to Identify Intracranial Hemorrhage by Using an In-Vitro Device, Tbit™ System
- Status
- Not Yet Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 740 (estimated)
- Sponsor
- BioDirection Inc · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Tbit system | Suspected traumatic brain injury with head CT |
Timeline
- Start date
- 2024-12-01
- Primary completion
- 2025-05-30
- Completion
- 2025-05-30
- First posted
- 2019-09-27
- Last updated
- 2024-04-05
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04107662. Inclusion in this directory is not an endorsement.