Clinical Performance Evaluation of T-TAS®01 HD Chip
NCT06087198 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43
Last updated 2025-07-28
Summary
The study is being conducted to validate the clinical performance of the T-TAS 01 HD assay for measurement of thrombogenicity in patients with thrombocytopenia receiving a platelet transfusion.
Conditions
Interventions
- DIAGNOSTIC_TEST
-
T-TAS 01 HD Assay
Disposable flow chamber microchip containing thrombogenic path to facilitate thrombus formation and occlusion
Sponsors & Collaborators
-
Fujimori Kogyo Co., Ltd.
collaborator UNKNOWN -
Hikari Dx, Inc.
lead OTHER
Principal Investigators
-
Jeffrey Dahlen, Ph.D. · Hikari Dx, Inc.
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-09-25
- Primary Completion
- 2025-06-30
- Completion
- 2025-06-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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