NCT06392269

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 443 (actual)
• Sponsor: Tasso Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: —

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

Interventions

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

Timeline

• Start date: 2024-03-18
• Primary completion: 2025-04-15
• Completion: 2025-04-15
• First posted: 2024-04-30
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study