Clinical trial NCT06392269: A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing
Official title: A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Serum Analytes
Lead sponsor: Tasso Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-30
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy individuals or patients with analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history

Brief 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


Eligibility criteria: Inclusion Criteria:

1. Adults aged 18 - 85 years
2. Willing and able to provide written informed consent prior to study entry
3. Willing and able to adhere to study assessments, schedule, prohibitions and restrictions as described in the protocol
4. Healthy individuals or patients with analyte values (verified or likely to be) within intended clinical reference ranges as indicated by standard of care testing and/or past medical history (which may be documented or self-reported)

Exclusion Criteria:

1. Present with abnormal skin integrity or atypical skin health near/on arm collection sites
2. Mental or physical impairment which would preclude participation in the judgement of the investigator or qualified designee
3. Laboratory and healthcare personnel.
4. Any condition which, in the opinion of the Investigator or delegate, makes the participant unsuitable for this study (including, but not limited to, any mental or physical impairment which would preclude provision of adequate and knowledgeable consent)

Primary outcomes:
measure: Number participants for which there is statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood
timeFrame: 2 Weeks
Secondary outcomes:
measure: Number of lay users in a simulated home setting for with statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood
timeFrame: 1 Day
measure: Number of observed device usability issues observed in lay users and HCP populations, i.e., deviations from the instructions for use.
timeFrame: 2 Weeks
measure: Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by two different HCPs
timeFrame: 2 weeks
measure: Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by the same lay user
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Tasso Research Clinic
state: Washington
Study officials:
References: