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

NCT06392269 | Completed FDA Device

• 1 other identifier: T23-02
• Study Type: observational
• Target: 443
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Serum Analytes

Outcome Measures

Primary Outcomes (1)

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

  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.

  2 Weeks

Secondary Outcomes (4)

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

  1 Day

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

  2 Weeks

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

  2 weeks

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

  2 Weeks

Study Arms (3)

Cohort 1

Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 1, two visit schedule.

Diagnostic Test: Tasso+SST

Cohort 2

Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 2, one visit schedule

Diagnostic Test: Tasso+SST

Cohort 3

Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 1, one visit schedule

Diagnostic Test: Tasso+SST

Interventions

Tasso+SST DIAGNOSTIC_TEST

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

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Tasso Inc.: lead

Study Sites (1)

Tasso Research Clinic

Seattle, Washington, 98119, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum obtained from whole blood

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2024
• First Posted: April 30, 2024
• Study Start: March 18, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: March 20, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)