NCT03621020

Clinical Performance Evaluation of T-TAS 01 PL Chip

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 307 (actual)
• Sponsor: Hikari Dx, Inc. · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Accepted

Summary

This study will measure primary hemostatic ability using the T-TAS 01 System with PL chip, with a comparison to clinical truth.

Detailed description

This study will measure primary hemostatic ability using the T-TAS 01 System with PL chip, with a comparison to clinical truth. The study will be conducted at 3 locations in the United States and will enroll approximately 335 subjects. The following subject populations will be enrolled into the study (expected enrollment numbers indicated in parentheses): * Ostensibly healthy subjects without primary hemostasis abnormalities, e.g. a "healthy platelet" normal control population (N = 150) * Subjects taking 81+ mg daily aspirin (N = 81) * Subjects taking dual antiplatelet therapy (N = 51) * Subjects with von Willebrand disease (vWD; N = 47) * Subjects with Glanzmann's thrombasthenia (N = 5) Subjects may be recruited either prospectively or based on their simultaneous participation in other studies involving blood collection, provided that the enrollment criteria. Blood samples will be collected after enrollment and subject participation will be complete after blood samples are collected and all necessary information is collected to complete the case report form (CRF). Blood sample testing with T-TAS 01 will occur locally at each investigational site. Blood sample testing for clinical truth assessment may be tested either locally or remotely, depending on the local availability of the various tests used for determining clinical truth.

Conditions

• Platelet Dysfunction
• Von Willebrand Diseases
• Healthy
• Congenital Platelets Abnormality

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	T-TAS 01 PL Chip	Flow chamber microchip system specific for measuring primary hemostatic ability
DIAGNOSTIC_TEST	PFA-100 Col/Epi and Col/ADP	System for measuring platelet dysfunction

Timeline

• Start date: 2018-09-01
• Primary completion: 2020-02-14
• Completion: 2020-02-14
• First posted: 2018-08-08
• Last updated: 2020-02-18

Locations

6 sites across 2 countries: United States, France

Regulatory

• FDA-regulated device study