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

NCT06507566 | Completed Results FDA Device

• 1 other identifier: 5309/0024
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Keywords

Tasso, Tasso+

Outcome Measures

Primary Outcomes (19)

• 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

  Day 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

  Day 29

• 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

  Day 57

• 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

  Day 1

• 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

  Day 29

• 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

  Day 57

• 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

  Day 1

• 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

  Day 1

• 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

  Day 1

• Assess the Reliability of Tasso+™

  Percentage of Tasso+™ device failure

  Day 1

• To Assess the Reliability of Tasso+™

  Percentage of Tasso+™ device failure

  Day 29

• Assess the Reliability of Tasso+™

  Percentage of Tasso+™ device failure

  Day 57

• 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

  Day 1

• 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

  Day 1

• 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

  Day 1

• 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

  Day 1

• 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

  Day 1

• 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

  Day 1

• 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

  Day 1

Secondary Outcomes (14)

• To Evaluate Tasso+™ User Experience (Safety)

  Within 7 days of Tasso+™ administration

• To Evaluate Tasso+™ User Experience (Safety)

  Day 29

• To Evaluate Tasso+™ User Experience (Safety)

  Day 29

• To Evaluate Tasso+™ User Experience (Tolerability)

  Day 57

• To Evaluate Tasso+™ User Experience (Usability)

  Day 1

Other Outcomes (7)

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

  Day 57

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

  Day 57

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

  Day 57

Study Arms (2)

Cohort A

ACTIVE COMPARATOR

Samples centrifuged/aliquoted after arrival at central lab.

Device: Tasso+™

Cohort B

ACTIVE COMPARATOR

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

Device: Tasso+™

Interventions

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.

Cohort A; Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alachua Government Services, Inc.: lead
• ICON Government and Public Health Solutions, Inc: collaborator
• Joint Program Executive Office Chemical, Biological, Radiological, and Nuclear Defense Enabling Biotechnologies: collaborator

Study Sites (1)

Victor Salib

Riverside, California, 92503, United States

Location

Results Point of Contact

• Title: Angie Kimbler
• Organization: Alachua Government Services, Inc.

angie.kimbler@resilience.com

386-418-8751

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2024
• First Posted: July 18, 2024
• Study Start: October 29, 2024
• Primary Completion: April 4, 2025
• Study Completion: April 4, 2025
• Last Updated: January 23, 2026
• Results First Posted: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)