Clinical trial NCT05259618: ALT Routinely Recorded Remotely: A Comparator Study of Liver Function Tests Using the Tasso+ to Venipuncture.
Official title: Project ARRR, ALT Routinely Recorded Remotely: A Comparator Study of Liver Function Tests Using the Tasso+ to Venipuncture.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Elevated Alanine Transaminase (ALT)
Lead sponsor: Tasso Inc.
Sponsor class: INDUSTRY
First posted: 2022-02-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with an ALT \> 3 X upper limit of normal

Brief summary: A direct comparison study of blood samples collected using the Tasso+ device and venous blood samples in patients with elevated alanine transaminase (ALT).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Subject must be willing and able to provide written informed consent prior to study entry
2. Subject is ≥ 18 years of age.
3. Subject must meet the following criterion:

   known recent history of liver function abnormality and requiring follow-up Liver tests (including ALT\>3XULN)
4. Subject must be willing and able to adhere to the assessments, study schedule, prohibitions and restrictions as described in the protocol.
5. Patients may be on any treatment / therapeutic clinical trial as indicated by treating physician

Exclusion Criteria:

1. Pregnant or nursing female by self-report.
2. Presents with abnormal skin integrity or atypical skin health within the areas to be tested (upper shoulders).
3. Subjects who have applied lotion to the skin on the shoulder the day of the visit.
4. Patients with hepatic encephalopathy
5. Vulnerable populations (children, prisoners, pregnant women, participants with diminished decision-making capacity, illiterate populations, educationally disadvantaged populations).

Primary outcomes:
measure: Venous and Tasso+ blood sample comparison for ALT
timeFrame: through study completion, an average of 1 Year and 6 Months
Secondary outcomes:
measure: Venous and Tasso+ blood sample comparison for additional analytes
timeFrame: through study completion, an average of 1 Year and 6 Months
measure: To collect patient experience with the Tasso blood collection
timeFrame: through study completion, an average of 1 Year and 6 Months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Anschutz Medical Campus
state: Colorado
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Kirkland
country: United States
facility: EvergreenHealth Research
state: Washington
Study officials:
References: