Evaluating a new device for collecting blood samples for testing
A Multi-site Clinical Evaluation of Capillary Blood Samples Collected Using the Tasso+SST Device for Downstream Analyte Testing.
Tasso Inc. · NCT06392269
This study is testing a new device that lets people collect their own blood samples to see if the results are just as accurate as those taken by healthcare providers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 220 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Tasso Inc. (industry) |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06392269 on ClinicalTrials.gov |
What this trial studies
This observational study involves participants self-collecting capillary blood samples using the Tasso+SST device at two visits spaced at least 14 days apart. Healthcare providers will also collect capillary and venous serum samples for comparison. The collected samples will be analyzed for various serum analytes to assess the accuracy and reliability of the Tasso+ device against traditional venous samples. The study aims to determine if self-collected samples can provide comparable results to those obtained by healthcare professionals.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18 to 85 who can provide informed consent and have analyte values within clinical reference ranges.
Not a fit: Patients with abnormal skin integrity near the collection sites or those with mental or physical impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enable easier and more accessible blood sample collection for patients.
How similar studies have performed: While similar approaches have been explored, this specific evaluation of the Tasso+SST device is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Seattle, Washington
- Tasso Research Clinic — Seattle, Washington, United States (RECRUITING)
Study contacts
- Study coordinator: Dema Poppa, MS
- Email: info@tassoinc.com
- Phone: (206) 822-4186
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Serum Analytes