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Completed

NCT Number: NCT06392269

A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing

This is a prospective, multi-center study within the U.S. Study participants will take part in two study visits a minimum of 14 days apart. During each visit, participants will self-collect capillary blood samples. Additionally, a healthcare provide will obtain capillary and venous serum samples. All capillary samples will be collected from the upper arm using the Tasso+ device paired with a commercially-available serum separator gel microtainer. The samples will be shipped to a clinical laboratory and tested for various analytes. Expected analyte values for each participant will be based on their venous sample results which will be compared to Tasso sample results

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Key information

Conditions

Serum Analytes

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tasso Research Clinic

Seattle, Washington, 98119, United States

Who can participate

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

Inclusion criteria

  • Adults aged 18 - 85 years
  • Willing and able to provide written informed consent prior to study entry
  • Willing and able to adhere to study assessments, schedule, prohibitions and restrictions as described in the protocol
  • Healthy individuals or patients with analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history (which may be documented or self-reported)

Exclusion criteria

  • Present with abnormal skin integrity or atypical skin health near/on arm collection sites
  • Mental or physical impairment which would preclude participation in the judgement of the investigator or qualified designee
  • Laboratory and healthcare personnel.
  • Any condition which, in the opinion of the Investigator or delegate, makes the participant unsuitable for this study (including, but not limited to, any mental or physical impairment which would preclude provision of adequate and knowledgeable consent)

Treatment and study plan

Tasso+SST

Diagnostic Test

Clinical evaluation of capillary blood samples collected using the Tasso+SST device for downstream analyte testing.

Primary outcomes

  1. Number participants for which there is statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood

    Time frame: 2 Weeks

    To establish the clinical performance of the Tasso+SST device for lay user self-collection and for trained healthcare provider (HCP) collection of capillary blood samples for downstream analyte testing at a clinical laboratory.

Secondary outcomes

  1. Number of lay users in a simulated home setting for with statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood

    Time frame: 1 Day

    To evaluate the performance of Tasso+SST capillary samples collected by lay users in a simulated home environment

  2. Number of observed device usability issues observed in lay users and HCP populations, i.e., deviations from the instructions for use.

    Time frame: 2 Weeks

    To demonstrate usability of the Tasso+SST device in naive lay users and in trained HCP populations

  3. Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by two different HCPs

    Time frame: 2 weeks

    To demonstrate HCP inter-operator precision of Tasso+SST samples

  4. Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by the same lay user

    Time frame: 2 Weeks

    To demonstrate lay user intra-operator precision of Tasso+SST samples

Sponsors and collaborators

Lead sponsor

Tasso Inc.

Industry

Registry information

Official study title

A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing.

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 30, 2024
Registry last updated
Mar 20, 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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