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

• Conditions: Elevated Alanine Transaminase (ALT)
• Interventions: Other: Tasso+ SST

• Registration Number: NCT05259618
• Lead Sponsor: Tasso Inc.

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.

Study Timeline

• Study Start: 2021-02-16
• Status Verified: 2022-02
• Study First Submitted: 2022-02-16
• Study First Submitted QC: 2022-02-24
• Last Update Submitted: 2022-02-24
• Study First Posted: 2022-02-28
• Last Update Posted: 2022-02-28
• Primary Completion: 2022-11
• Study Completion: 2022-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with elevated alanine transaminase (ALT)	Tasso+ SST	patients with alanine transaminase (ALT) \> 3x upper limit of normal (ULN).

Primary Outcome Measures

Name	Time	Method
Venous and Tasso+ blood sample comparison for ALT	through study completion, an average of 1 Year and 6 Months	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.

Secondary Outcome Measures

Name	Time	Method
Venous and Tasso+ blood sample comparison for additional analytes	through study completion, an average of 1 Year and 6 Months	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.
To collect patient experience with the Tasso blood collection	through study completion, an average of 1 Year and 6 Months	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.

Trial Locations

Locations (3)

University of Colorado Anschutz Medical Campus; 🇺🇸 Aurora, Colorado, United States

EvergreenHealth Research; 🇺🇸 Kirkland, Washington, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States