Back to resultsTbit System Precision and Correlation of Different Blood Samples
Primary Purpose
Brain Injuries, Traumatic Brain Injury
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Single Group Assignment
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Injuries
Eligibility Criteria
Inclusion Criteria:
- 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)
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 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Group Assignment
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04478812
Brief Title
Tbit System Precision and Correlation of Different Blood Samples
Official Title
A Prospective, Multi-Center, Blood Collection Study to Evaluate TbitTM System Precision and Correlation Between Different Blood Samples Measured With TbitTM System
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 15, 2022 (Anticipated)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioDirection Inc
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries, Traumatic Brain Injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
81 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Single Group Assignment
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Single Group Assignment
Intervention Description
Tbit™ System will detect S100B and GFAP concentrations with the blood specimen collected
Primary Outcome Measure Information:
Title
Measurement Repeatability
Description
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.
Time Frame
within 12 hours from injury for Tbit and within 30 min from the sample drawn
Title
Compare Measurements
Description
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.
Time Frame
within 12 hours from injury
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lelia A Paunescu, PhD
Phone
7815268152
Email
apaunescu@medicept.com
First Name & Middle Initial & Last Name or Official Title & Degree
Travis Jones, BSc
Phone
6783207670
Email
tjones@medicept.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerika Acosta, BSc
Organizational Affiliation
Medicept Inc
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Tbit System Precision and Correlation of Different Blood Samples
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