Tbit System Precision and Correlation of Different Blood Samples

NCT04478812 | Not Yet Recruiting FDA Device

• 1 other identifier: BDI-TBIT-04
• Study Type: interventional
• Target: 81
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Tbit™ System will detect S100B and GFAP concentrations with the blood specimen to produce and compare repeated measures from 3 blood samples from 3 fingersticks from one subject and one 1 venous whole blood sample will be collected from the same subject, on 3 different Tbit™ System by 3 different operators.

Conditions

Brain Injuries; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (2)

• Measurement Repeatability

  1\. Evaluate the repeatability of measurement of S100B and GFAP concentrations in capillary blood using the Tbit™ System at different clinical sites and between-instrument and between-operator components of variance in the intended use environment.

  within 12 hours from injury for Tbit and within 30 min from the sample drawn

• Compare Measurements

  2\. Compare concentrations of S100B and GFAP measured using Tbit™ System in specimens obtained from a fingerstick blood, venous whole blood, serum and plasma in the intended use environment.

  within 12 hours from injury

Study Arms (1)

Single Group Assignment

EXPERIMENTAL

Diagnostic Test: Single Group Assignment

Interventions

Single Group Assignment DIAGNOSTIC_TEST

Tbit™ System will detect S100B and GFAP concentrations with the blood specimen collected

Single Group Assignment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• Presents to the Emergency Department with suspected traumatic brain 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)

You may not qualify if:

• 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 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

Sponsors & Collaborators

• BioDirection Inc: lead

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jerika Acosta, BSc

  Medicept Inc.

  STUDY DIRECTOR

Central Study Contacts

Lelia A Paunescu, PhD

CONTACT

7815268152; apaunescu@medicept.com

Travis Jones, BSc

CONTACT

6783207670; tjones@medicept.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2020
• First Posted: July 21, 2020
• Study Start: September 15, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04