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Study Summary
This is a prospective, multi-center study within the U.S. 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
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number participants for which there is statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood
Secondary outcome measures
Number of lay users in a simulated home setting for with statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood
Number of observed device usability issues observed in lay users and HCP populations, i.e., deviations from the instructions for use.
Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by the same lay user
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Tasso+Experimental Treatment1 Intervention
Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture
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Who is running the clinical trial?
Tasso Inc.Lead Sponsor
3 Previous Clinical Trials
578 Total Patients Enrolled
Frequently Asked Questions
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