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Clinical Performance Evaluation of T-TAS 01 PL Chip

NCT03621020 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 307

Last updated 2020-02-18

No results posted yet for this study

Summary

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

Conditions

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

Interventions

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

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
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2020-02-14
Completion
2020-02-14
FDA Device
Yes

Countries

  • United States
  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03621020 on ClinicalTrials.gov