Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06392269
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-04-07
Brief Title:
A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the TassoSST Device for Downstream Analyte Testing
Sponsor:
Tasso Inc
Organization:
Tasso Inc
Study Overview
Official Title:
A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the TassoSST Device for Downstream Analyte Testing
Status:
RECRUITING
Status Verified Date:
2024-04
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 is a prospective multi-center study within the US Study participants will take part in two study visits a minimum of 14 days apart During each visit participants will self-collect capillary blood samples Additionally a healthcare provide will obtain capillary and venous serum samples All capillary samples will be collected from the upper arm using the Tasso device paired with a commercially-available serum separator gel microtainer The samples will be shipped to a clinical laboratory and tested for various analytes Expected analyte values for each participant will be based on their venous sample results which will be compared to Tasso sample results
Detailed Description:
None
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?:
False
Is an FDA AA801 Violation?:
None