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HealthyNCT06507566

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

A study testing Tasso+™ in people with Healthy, run by Alachua Government Services, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A study evaluating technologies for point-of-care use in clinical trials. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Tasso+™
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
29 Oct 2024to 4 Apr 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
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  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Victor Salib

    Riverside, California, 92503

Other trials in United States

About this study

Official title: Phase 1 Study Evaluating Technologies for Point-of-Care Blood Collections in Support of Decentralized Outpatient Assessments in Pandemic and Clinical Trial Settings

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

Read the 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
Being tested
Tasso+™
Keywords
Tasso, Tasso+

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tasso+™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.

Study groups in NCT06507566
Study groupRoleWhat they receive
Cohort AActive comparatorSamples centrifuged/aliquoted after arrival at central lab.
Receives: Device: Tasso+™
Cohort BActive comparatorSamples centrifuged/aliquoted at collection Site before shipment to central lab.
Receives: Device: Tasso+™

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the Sample Integrity of Tasso+™

    Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis

    Measured: Day 1

  2. Assess the Sample Integrity of Tasso+™

    Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis

    Measured: Day 29

  3. Assess the Sample Integrity of Tasso+™

    Percentage of overall Tasso+™/serum separator tube (SST) samples collected that are with adequate volume and without moderate or gross hemolysis

    Measured: Day 57

  4. Assess the Sample Integrity of Tasso+™

    Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting

    Measured: Day 1

  5. Assess the Sample Integrity of Tasso+™

    Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting

    Measured: Day 29

  6. Assess the Sample Integrity of Tasso+™

    Percentage of overall Tasso+™/ ethylenediaminetetraacetic acid (EDTA) samples collected that are with adequate volume, without moderate or gross hemolysis, and without clotting

    Measured: Day 57

  7. Assess the Testing Accuracy of Tasso+™

    Correlation of SARS-CoV-2 (positive for IgG antibody) serology between venipuncture and Tasso+™/SST or Tasso+™/EDTA samples for Cohort A

    Measured: Day 1

  8. Assess the Testing Accuracy of Tasso+™

    Correlation of SARS-CoV-2 (positive for IgG antibody) serology between venipuncture and Tasso+™/SST or Tasso+™/EDTA samples for Cohort B

    Measured: Day 1

  9. Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Sodium

    Correlation of sodium between venipuncture and Tasso+™/SST samples for each cohort

    Measured: Day 1

  10. Assess the Reliability of Tasso+™

    Percentage of Tasso+™ device failure

    Measured: Day 1

  11. To Assess the Reliability of Tasso+™

    Percentage of Tasso+™ device failure

    Measured: Day 29

  12. Assess the Reliability of Tasso+™

    Percentage of Tasso+™ device failure

    Measured: Day 57

  13. Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Potassium

    Correlation of potassium between venipuncture and Tasso+™/SST samples for each cohort

    Measured: Day 1

  14. Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Chloride

    Correlation of chloride between venipuncture and Tasso+™/SST samples for each cohort

    Measured: Day 1

  15. Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Creatinine

    Correlation of creatinine between venipuncture and Tasso+™/SST samples for each cohort

    Measured: Day 1

  16. Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Glucose

    Correlation of glucose between venipuncture and Tasso+™/SST samples for each cohort

    Measured: Day 1

  17. Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Phosphate

    Correlation of phosphate between venipuncture and Tasso+™/SST samples for each cohort

    Measured: Day 1

  18. Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for Urate

    Correlation of urate between venipuncture and Tasso+™/SST samples for each cohort

    Measured: Day 1

  19. Assess the Testing Accuracy of Tasso+™ as Compared to Samples Collected Via Venipuncture for C-reactive Protein

    Correlation of C-reactive protein between venipuncture and Tasso+™/SST samples for each cohort

    Measured: Day 1

Secondary outcomes (14)

  1. To Evaluate Tasso+™ User Experience (Safety)

    Percentage of eligible participants who experience solicited local adverse events (AEs) including pain, tenderness, redness, swelling, or bruising within 7 days of Tasso+™ administration

    Measured: Within 7 days of Tasso+™ administration

  2. To Evaluate Tasso+™ User Experience (Safety)

    Percentage of eligible subjects who experienced unsolicited AEs within 28 days of Tasso+™ administration

    Measured: Day 29

  3. To Evaluate Tasso+™ User Experience (Safety)

    Percentage of eligible subjects who experienced a related Grade 3 AE, a related Grade 4 AE, a related AE leading to study discontinuation, or a related SAE within 28 days of Tasso+™ administration

    Measured: Day 29

  4. To Evaluate Tasso+™ User Experience (Tolerability)

    Percentage of eligible participants who complete last Tasso+™ administration (Day 57)

    Measured: Day 57

  5. To Evaluate Tasso+™ User Experience (Usability)

    Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration

    Measured: Day 1

  6. To Evaluate Tasso+™ User Experience (Usability)

    Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration

    Measured: Day 29

  7. To Evaluate Tasso+™ User Experience (Usability)

    Ease of use as assessed by the participant completing the Tasso questionnaire immediately following administration

    Measured: Day 57

  8. To Evaluate Tasso+™ User Experience (Usability)

    Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire

    Measured: Day 85

  9. To Perform Surveillance for SARS-CoV-2 Infection

    Percentage of eligible participants with a positive nasopharyngeal swab for SARS-CoV-2 polymerase chain reaction (PCR) on Day 1

    Measured: Day 1

  10. To Perform Surveillance for SARS-CoV-2 Infection

    Percentage of eligible participants seroconverting to SARS-CoV-2 between Days 1 and 57

    Measured: Between Days 1 and 57

  11. To Evaluate Tasso+™ User Experience (Usability)

    Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire

    Measured: Day 29

  12. To Evaluate Tasso+™ User Experience (Usability)

    Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire

    Measured: Day 57

  13. To Evaluate Tasso+™ User Experience (Usability)

    Willingness to use the Tasso device was assessed by the participant completing the Tasso questionnaire

    Measured: Day 1

  14. To Evaluate Tasso+™ User Experience (Usability)

    Preferred method for future blood sampling was assessed by the participant completing the Tasso questionnaire

    Measured: Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jul 2024
  2. Study start29 Oct 2024
  3. Primary completion4 Apr 2025
  4. Study completion4 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06507566
Sponsor's protocol ID
5309/0024
Status last verified
Jan 2026
First submitted
24 Jun 2024
Last updated
23 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Tasso+™ in people with Healthy, run by Alachua Government Services, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess the Sample Integrity of Tasso+™ (time frame: Day 1). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06507566.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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