NCT06710262

T-TAS® wS Method Comparison

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 115 (actual)
• Sponsor: Hikari Dx, Inc. · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This study involves the collection of blood samples and measurement with the T-TAS PL assay to compare the performance of the T-TAS wS instrument to the T-TAS 01 instrument

Detailed description

This study will compare PL assay measurements obtained with the T-TAS wS instrument (subject device) with PL assay measurements obtained with the T-TAS 01 instrument (predicate method). The T-TAS PL assay will be used to facilitate the comparison between instruments using intended use blood samples from the intended use population. The study will be conducted at a minimum of 3 locations in the United States and will enroll up to 120 subjects. The following subject populations will be enrolled into the study (minimum enrollment numbers indicated in parentheses): * Ostensibly healthy subjects * Subjects taking 81 mg or higher daily aspirin monotherapy (ASA) * Subjects taking dual antiplatelet therapy (DAPT) * Subjects with von Willebrand disease (VWD)

Conditions

• Antiplatelet Therapy
• Healthy Donors
• Von Willebrand Disease (VWD)

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	T-TAS PL Assay	The T-TAS PL assay is a flow chamber assay for measuring primary hemostatic function

Timeline

• Start date: 2024-08-21
• Primary completion: 2025-07-14
• Completion: 2025-07-14
• First posted: 2024-11-29
• Last updated: 2025-07-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study