ALT Routinely Recorded Remotely: A Comparator Study of Liver Function Tests Using the Tasso+ to Venipuncture. (ARRR)

Tasso Inc.

Status: Unknown

Conditions: Elevated Alanine Transaminase (ALT)

Treatments: Other: Tasso+ SST

Study type: Observational

Funder types: Industry

Identifiers

NCT05259618

TALT01-20

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

80 participants in 1 patient group

Patients with elevated alanine transaminase (ALT)

Description:

patients with alanine transaminase (ALT) \> 3x upper limit of normal (ULN).

Treatment:

Other: Tasso+ SST