Evaluation of Tasso+ Blood Self-Collection for Clinical Diagnostic Assessment of Various Biomarkers (NCT05852925) | Clinical Trial Compass
RecruitingNot Applicable
Evaluation of Tasso+ Blood Self-Collection for Clinical Diagnostic Assessment of Various Biomarkers
United States2,500 participantsStarted 2023-07-25
Plain-language summary
This study aims to assess the effectiveness and reliability of the Tasso+ capillary blood self-collection device in the clinical diagnostic assessment of various biomarkers. The study will collect blood specimens using both the Tasso+ self-collection device and traditional venipuncture. The biomarker analysis results from both specimen types will be compared for correlation.
Who can participate
Age range13 Years
SexALL
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Inclusion criteria
ā. Age: Participants must be 13 years of age or older.
ā. Medical history: There may be no specific medical history requirements for inclusion, although participants may need to meet certain general health criteria.
ā. Sample type: Participants must be willing and able to provide the human specimens needed for the study, such as blood, urine, or saliva.
ā. Ability to provide consent: Participants must have the ability to provide informed consent to participate in the study, either on their own behalf if they are legally able to do so, or with the consent of a parent or guardian if they are under 18 years of age.
ā. Language proficiency: Participants must be able to read and understand the language used in the study materials, such as informed consent forms and instructions for specimen collection.
Exclusion criteria
ā. Blind or visually impaired: Participants who are unable to see or have significant visual impairment that would make it difficult for them to participate in the study.
ā. Decisionally impaired: Participants who are unable to provide informed consent due to cognitive impairment, developmental disability, or other mental health conditions that affect decision-making capacity.
ā. Educationally disadvantaged: Participants who lack the education or literacy skills required to understand the study procedures or provide informed consent.
ā. Hospitalized: Participants who are currently hospitalized, as they may not be able to participate in the study due to their medical condition or limited mobility.
What they're measuring
1
Venous and Tasso+ blood sample correlation for biomarkers being tested.
ā. Prisoners: Participants who are incarcerated in correctional facilities, as their participation may raise ethical concerns or require additional regulatory approvals.
ā. Terminally ill: Participants who have a terminal illness or life-limiting condition that may affect the study results or pose additional risks to their health.