Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360952
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-21
First Post:
2024-02-02
Brief Title:
A Comparator Study of a Tasso Device Blood Sample to Traditional Venous Blood Sample for CBC
Sponsor:
Tasso Inc
Organization:
Tasso Inc
Study Overview
Official Title:
A Comparator Study of a Tasso Device to Traditional Venous Blood Sampling Methods for Complete Blood Count CBC With 5-part Differential in Patients With Leukemia Lymphoma andor Other Blood Cell Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia lymphoma andor other blood cell disorders
This investigation will include a minimum of 40 sample sets from unique patients
This investigation will include a minimum of 40 sample sets from unique patients
Detailed Description:
This study will evaluate the feasibility of using capillary blood samples collected with the Tasso device for analysis of CBC in diseased patients with leukemia lymphoma andor other blood cell disorders
This investigation will include a minimum of 40 sample sets from unique patients
The primary aim of this study is to demonstrate the agreement between capillary blood collected using the Tasso device and venous blood collected in a K2EDTA dipotassium ethylenediaminetetraacetic acid tube according to established sampling procedures for quantification of WBC and ANC as part of a standard CBC panel with 5-part differential
The secondary aim of the study is to demonstrate the agreement between Tasso device and venous samples for the measurement of additional analytes evaluated as part of a standard CBC panel with 5-part differential including PLTs HGB RBC Hct MCV lymphocytes monocytes eosinophils and basophils
An exploratory aim of this research is to evaluate patient acceptance of the Tasso device in a diseased population
Adverse Events AEs occurring up to 24 hours after use of the Tasso device will be evaluated
Patient response to using the Tasso device will be collected via simple survey
This investigation will include a minimum of 40 sample sets from unique patients
The primary aim of this study is to demonstrate the agreement between capillary blood collected using the Tasso device and venous blood collected in a K2EDTA dipotassium ethylenediaminetetraacetic acid tube according to established sampling procedures for quantification of WBC and ANC as part of a standard CBC panel with 5-part differential
The secondary aim of the study is to demonstrate the agreement between Tasso device and venous samples for the measurement of additional analytes evaluated as part of a standard CBC panel with 5-part differential including PLTs HGB RBC Hct MCV lymphocytes monocytes eosinophils and basophils
An exploratory aim of this research is to evaluate patient acceptance of the Tasso device in a diseased population
Adverse Events AEs occurring up to 24 hours after use of the Tasso device will be evaluated
Patient response to using the Tasso device will be collected via simple survey
Study Oversight
Has Oversight DMC:
None
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?:
True
Is an FDA AA801 Violation?:
None