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A direct comparison study of blood samples collected using the Tasso+ device and venous blood samples in patients with elevated alanine transaminase (ALT).
This is a prospective, non-blinded, multi-center study to be conducted within the USA. This study will consist of a single arm. Blood will be drawn from each subject, using two different collection methods: the Tasso+ device and the conventional venipuncture method. The results will be compared assess correlation between blood collected at home, by the patient, using the Tasso+ device and blood collected in the office using a Vacutainer (SST, Red Top tube) using venipuncture for alanine transaminase (ALT), aspartate aminotransferase (AST) and total bilirubin.
Participants can complete up to 3 visits and will include self-collected blood samples using the Tasso+ device at home on the day of visit 2 and visit 3.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with elevated alanine transaminase (ALT) | patients with alanine transaminase (ALT) > 3x upper limit of normal (ULN). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tasso+ SST | Other | alternative site blood sample collection. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Venous and Tasso+ blood sample comparison for ALT | Correlation between blood collected at home, by the patient, using the Tasso+ device and blood collected in the office using a Vacutainer (SST, Red Top tube) using venipuncture for ALT, AST and total bilirubin, quantified using a Roche Cobas 8000/c702 or an equivalent analyzer. | through study completion, an average of 1 Year and 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Venous and Tasso+ blood sample comparison for additional analytes | Correlation of additional analytes including Total Protein, Albumin, Glucose, Sodium, Potassium, Chloride, Magnesium, Calcium, Phosphorus, Enzymatic Creatinine and alkaline Phosphatase (ALP) in blood collected with the Tasso+ device and by venipuncture in a Vacutainer (SST, Red Top tube) analyzed using a Roche Cobas 8000/c702 or an equivalent analyzer or an equivalent analyzer. |
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Inclusion Criteria:
Subject must be willing and able to provide written informed consent prior to study entry
Subject is ≥ 18 years of age.
Subject must meet the following criterion:
known recent history of liver function abnormality and requiring follow-up Liver tests (including ALT>3XULN)
Subject must be willing and able to adhere to the assessments, study schedule, prohibitions and restrictions as described in the protocol.
Patients may be on any treatment / therapeutic clinical trial as indicated by treating physician
Exclusion Criteria:
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Patients with an ALT > 3 X upper limit of normal
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brook Quist | Contact | (206) 822-4186 | 1004 | brook@tassoinc.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado Anschutz Medical Campus | Not yet recruiting | Aurora | Colorado | 80045 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36533519 | Derived | Wickremsinhe E, Fantana A, Berthier E, Quist BA, Lopez de Castilla D, Fix C, Chan K, Shi J, Walker MG, Kherani JF, Knoderer H, Regev A, Harding JJ. Standard Venipuncture vs a Capillary Blood Collection Device for the Prospective Determination of Abnormal Liver Chemistry. J Appl Lab Med. 2023 May 4;8(3):535-550. doi: 10.1093/jalm/jfac127. |
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| through study completion, an average of 1 Year and 6 Months |
| To collect patient experience with the Tasso blood collection | To collect patient experience with the Tasso blood collection utilizing a brief survey aimed at understanding patient experience and preferences on the use and adoption of Tasso+ to collect a blood sample independently (with the help of a caregiver if needed), outside of the clinic. | through study completion, an average of 1 Year and 6 Months |
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10017 | United States |
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| EvergreenHealth Research | Recruiting | Kirkland | Washington | 98034 | United States |
|