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OpenTrials
Completed

NCT Number: NCT06507566

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

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

Completed

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Victor Salib

Riverside, California, 92503, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Assess the Sample Integrity of Tasso+™

    Time frame: Day 1

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

  2. Assess the Sample Integrity of Tasso+™

    Time frame: Day 29

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

  3. Assess the Sample Integrity of Tasso+™

    Time frame: Day 57

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

  4. Assess the Sample Integrity of Tasso+™

    Time frame: Day 1

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

  5. Assess the Sample Integrity of Tasso+™

    Time frame: Day 29

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

  6. Assess the Sample Integrity of Tasso+™

    Time frame: Day 57

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

  7. Assess the Testing Accuracy of Tasso+™

    Time frame: Day 1

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

  8. Assess the Testing Accuracy of Tasso+™

    Time frame: Day 1

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

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

    Time frame: Day 1

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

  10. Assess the Reliability of Tasso+™

    Time frame: Day 1

    Percentage of Tasso+™ device failure

  11. To Assess the Reliability of Tasso+™

    Time frame: Day 29

    Percentage of Tasso+™ device failure

  12. Assess the Reliability of Tasso+™

    Time frame: Day 57

    Percentage of Tasso+™ device failure

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

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

    Time frame: Day 1

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

Secondary outcomes

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

    Time frame: Within 7 days of Tasso+™ administration

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

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

    Time frame: Day 29

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

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

    Time frame: Day 29

    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

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

    Time frame: Day 57

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

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

    Time frame: Day 1

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

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

    Time frame: Day 29

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

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

    Time frame: Day 57

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

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

    Time frame: Day 85

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

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

    Time frame: Day 1

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

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

    Time frame: Between Days 1 and 57

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

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

    Time frame: Day 29

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

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

    Time frame: Day 57

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

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

    Time frame: Day 1

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

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

    Time frame: Day 85

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

Other outcomes

  1. To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Sample Integrity

    Time frame: Day 57

    Percentage of Tasso+™/SST samples collected that are with adequate volume and without moderate or gross hemolysis between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57

  2. To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Sample Integrity

    Time frame: Day 57

    Percentage of Tasso+™/EDTA samples collected that are with adequate volume and without moderate or gross hemolysis between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57

  3. To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Reliability

    Time frame: Day 57

    Percentage of Tasso+™ device failure between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57

  4. To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety

    Time frame: Within 7 days of Tasso+™ administration on Day 57, up to a maximum of 64 days

    Percentage of subjects with solicited local AEs within 7 days of Tasso+™ administration on Day 57 between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™

  5. To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Safety

    Time frame: Within 28 days of Tasso+™ administration on Day 57, up to Day 85

    Percentage of subjects with unsolicited AEs, related Grade 3 AE, related Grade 4 AE, related AE leading to discontinuation, or related SAE within 28 days of Tasso+™ administration on between patients who requested proctor-supported and those who did not request proctor-supported for the usage of Tasso+™ on Day 57

  6. To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability

    Time frame: Day 57

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

  7. To Evaluate the Impact of Prior Training on Subsequent Tasso+™ Administrations and Usability

    Time frame: Day 57

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

Sponsors and collaborators

Lead sponsor

Alachua Government Services, Inc.

Industry

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 18, 2024
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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