Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2026-02-22 @ 5:23 PM
Study NCT ID:
NCT03621020
Status:
COMPLETED
Last Update Posted:
2020-02-18
First Post:
2018-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Performance Evaluation of T-TAS 01 PL Chip
Sponsor:
Hikari Dx, Inc.
Organization:
Study Overview
Official Title:
Clinical Performance Evaluation of T-TAS 01 PL Chip
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: