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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks
Awards & highlights
No Placebo-Only Group
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number participants for which there is statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial 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
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