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

NCT ID: NCT06507566

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-29
• Study Completion Date: 2025-04-04

Brief Summary

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

Detailed 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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Cohort A

Samples centrifuged/aliquoted after arrival at central lab.

Group Type: ACTIVE_COMPARATOR

Tasso+™

Intervention Type: DEVICE

The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.

Cohort B

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

Group Type: ACTIVE_COMPARATOR

Tasso+™

Intervention Type: DEVICE

The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.

Interventions

Tasso+™

The Tasso+™ blood collection kit is a collection device (called the Tasso+™) and a capillary collection tube that allows for the storage of the blood in a liquid format in different matrices.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ICON Government and Public Health Solutions, Inc

UNKNOWN

Sponsor Role: collaborator

Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies

OTHER_GOV

Sponsor Role: collaborator

Alachua Government Services, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Victor Salib

Riverside, California, United States

Countries

United States

Other Identifiers

5309/0024

Identifier Type: -

Identifier Source: org_study_id