Serum AnalytesNCT06392269
A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing
An observational study of Serum Analytes, run by Tasso Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Serum Analytes
- What is being tested?
- Tasso+SST
- How many people
- 443 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2024to 15 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- Adults aged 18 - 85 years
- Willing and able to provide written informed consent prior to study entry
- Willing and able to adhere to study assessments, schedule, prohibitions and restrictions as described in the protocol
- 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)
Who cannot join
- Present with abnormal skin integrity or atypical skin health near/on arm collection sites
- Mental or physical impairment which would preclude participation in the judgement of the investigator or qualified designee
- Laboratory and healthcare personnel.
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing.
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
- Conditions
- Serum Analytes
- Being tested
- Tasso+SST
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tasso+SSTDiagnostic test
Clinical evaluation of capillary blood samples collected using the Tasso+SST device for downstream analyte testing.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 1, two visit schedule. Receives: Diagnostic Test: Tasso+SST | |
| Cohort 2 | Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 2, one visit schedule Receives: Diagnostic Test: Tasso+SST | |
| Cohort 3 | Comparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 1, one visit schedule Receives: Diagnostic Test: Tasso+SST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number participants for which there is statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood
To establish the clinical performance of the Tasso+SST device for lay user self-collection and for trained healthcare provider (HCP) collection of capillary blood samples for downstream analyte testing at a clinical laboratory.
Measured: 2 Weeks
Secondary outcomes (4)
Number of lay users in a simulated home setting for with statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood
To evaluate the performance of Tasso+SST capillary samples collected by lay users in a simulated home environment
Measured: 1 Day
Number of observed device usability issues observed in lay users and HCP populations, i.e., deviations from the instructions for use.
To demonstrate usability of the Tasso+SST device in naive lay users and in trained HCP populations
Measured: 2 Weeks
Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by two different HCPs
To demonstrate HCP inter-operator precision of Tasso+SST samples
Measured: 2 weeks
Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by the same lay user
To demonstrate lay user intra-operator precision of Tasso+SST samples
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2024
- Study start18 Mar 2024
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serum AnalytesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasso Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06392269
- Sponsor's protocol ID
- T23-02
- Status last verified
- Mar 2026
- First submitted
- 7 Apr 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Research results are proprietary; no sharing with other researchers is anticipated.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing.
- ClinicalTrials.gov ID
- NCT06392269
- Acronym / sponsor ID
- T23-02
- Conditions
- Serum Analytes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Tasso Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 30 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Diagnostic Test: Tasso+SSTComparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 1, two visit schedule. |
| Cohort 2 | – | Diagnostic Test: Tasso+SSTComparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 2, one visit schedule |
| Cohort 3 | – | Diagnostic Test: Tasso+SSTComparison of capillary blood collected with a Tasso+ lancet vs. venous blood obtained via venipuncture - Platform 1, one visit schedule |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Adults aged 18 - 85 years
- Willing and able to provide written informed consent prior to study entry
- Willing and able to adhere to study assessments, schedule, prohibitions and restrictions as described in the protocol
- 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)
Key exclusion criteria (4 listed)
- Present with abnormal skin integrity or atypical skin health near/on arm collection sites
- Mental or physical impairment which would preclude participation in the judgement of the investigator or qualified designee
- Laboratory and healthcare personnel.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tasso+SSTClinical evaluation of capillary blood samples collected using the Tasso+SST device for downstream analyte testing. | Diagnostic test | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Number participants for which there is statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood
Time frame: 2 Weeks
To establish the clinical performance of the Tasso+SST device for lay user self-collection and for trained healthcare provider (HCP) collection of capillary blood samples for downstream analyte testing at a clinical laboratory.
4 secondary outcomes
Number of lay users in a simulated home setting for with statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood
Time frame: 1 Day
Number of observed device usability issues observed in lay users and HCP populations, i.e., deviations from the instructions for use.
Time frame: 2 Weeks
Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by two different HCPs
Time frame: 2 weeks
Number participants for which there is statistical concordance between serum biomarker results obtained from Tasso+ capillary blood by the same lay user
Time frame: 2 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No. Research results are proprietary; no sharing with other researchers is anticipated.
Related trials for Serum Analytes
Active, not recruitingObservational study
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Serum Analytes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Serum Analytes, run by Tasso Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number participants for which there is statistical concordance between serum biomarker results obtained from capillary blood vs. venous blood (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.