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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04107662
Other study ID # BDI-TBIT-03
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2024
Est. completion date May 30, 2025

Study information

Verified date April 2024
Source NanoDx
Contact Adelina A Paunescu, PhD
Phone 7815268152
Email apaunescu@medicept.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 740
Est. completion date May 30, 2025
Est. primary completion date May 30, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least 18 years of age - Presents to the Emergency Department with suspected traumatic brain injury - Prescribed a non-contrast CCT as part of routine emergency care within 24 hours from injury - Blood sample collected for Tbit™ System within 12 hours of injury - Willing and able to provide informed consent or obtain consent from legal authorized representative (LAR) Exclusion Criteria: - Suspect of ischemic or hemorrhagic stroke with subsequent incidental trauma based on ED examination - Subject suspect of need of craniotomy for the acute trauma for this event - External signs compatible with a depressed skull fracture based on ED exam - Subject requiring administration of blood transfusion after injury and prior to study blood draw - Subject for whom timing of injury is unable to be estimated within 1 hour of certainty - Subject with a condition precluding entry into the CT scanner - Subject who had neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizures, brain tumors, stroke or TIA within the last 30 days, or history of neurosurgery - Known or suspected to be pregnant - Prisoner or under incarceration - Participating in another clinical research study prior to this study completion

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Tbit system
Suspected traumatic brain injury with head CT

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
BioDirection Inc

Outcome

Type Measure Description Time frame Safety issue
Other Tbit™ System User Satisfaction Survey Tbit™ System User Satisfaction Survey to evaluate the Tbit ease of use by device operators 6 months
Primary Cranial CT Intracranial Hemorrhage findings and the binary Tbit™ System (positive/negative) Cranial CT Intracranial Hemorrhage findings (positive/negative) and the binary Tbit™ System results (positive/negative) of each sample. within 12 hours from injury on day 0 of ED presentation
Primary Tbit™ System sensitivity and specificity Tbit™ System sensitivity and specificity relative to the standard-of-care (SOC) within 12 hours from injury on day 0 of ED presentation
Secondary Negative predictive value of the Tbit™ System Negative predictive value of the Tbit™ System within 12 hours from injury on day 0 of ED presentation
Secondary Positive predictive value of the Tbit™ System Positive predictive value of the Tbit™ System within 12 hours from injury on day 0 of ED presentation
Secondary Overall accuracy of the Tbit™ System Overall accuracy of the Tbit™ System within 12 hours from injury on day 0 of ED presentation
Secondary Safety and adverse event profile Safety and adverse event profile 6 months
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