Evaluating Technologies for Point-of-Care Blood Collections by Patients

Alachua Government Services, Inc.

Status: Completed

Conditions: Healthy

Treatments: Device: Tasso+™

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06507566

5309/0024

Details and patient eligibility

About

A study evaluating technologies for point-of-care use in clinical trials.

Full description

A study evaluating the Tasso+ blood collection device that enables the safe and convenient collection of blood by a lay person (eg, patient or study participant) under the supervision of an Health Care Provider.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female adults (18 years of age or older, inclusive), at the time of informed consent. Participants who are deemed pregnant by urine pregnancy test at Screening remain eligible.
• Able to understand and willing to provide informed consent and able to comply with the study procedures and restrictions.
• Participant considered healthy or in well-compensated health according to medical history, concomitant medications, and physical examination (including vital signs).

Exclusion criteria

• Medical history, or physical examination (including vital signs) findings, that suggest to the Investigator that the participant has undiagnosed or untreated medical condition(s) that could confound the AE evaluation and thereby undermine the study objectives.
• Any known medical history of infection with HIV (CD4<200 and/or detectable viral load within the prior 3 months), hepatitis B (positive HBsAg), or hepatitis C (positive hepatitis C virus antibody).
• Chronic illness for which a participant's immune system is suspected by the Investigator to be impaired or altered, such as cancer, autoimmune conditions, and diabetes.
• Participation in another investigational study within 30 days of time of consent or plans to do so during the course of this study.
• Large tattoos or skin eruptions overlying either of the deltoid muscles that could confound the monitoring for local reactogenicity following Tasso+™ administrations.
• Use of systemic immunomodulatory therapy, including oral corticosteroids, within the past 6 months; or planned use of medications or nutritional supplements known to or which potentially could affect organ function within 30 days prior to screening until end of study.
• Acute illness within 14 days prior to device use unless it is determined by the Investigator that the illness is mild in severity and unlikely to progress.
• Of limited legal capacity.
• Any condition (including suspected alcohol- or drug-related addiction) that precludes adequate understanding, cooperation, and/or compliance with study procedures or any condition that could pose a risk to the participant's safety per Investigator judgment.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Cohort A

Active Comparator group

Description:

Samples centrifuged/aliquoted after arrival at central lab.

Treatment:

Device: Tasso+™

Cohort B

Active Comparator group

Description:

Samples centrifuged/aliquoted at collection Site before shipment to central lab.

Treatment:

Device: Tasso+™