Recruiting

Liver Function Tests

Sponsor:

Tasso Inc.

Code:

NCT05259618

Conditions

Elevated Alanine Transaminase (ALT)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tasso+ SST

Study Details

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).

Conditions

Elevated Alanine Transaminase (ALT)

Study ID

NCT05259618

Start date

Feb 16, 2021

Status verified date

Feb, 2022

Completion date

Nov, 2022

Anticipated

Primary completion date

Nov, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Patients with elevated alanine transaminase (ALT)

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

Interventions

Tasso+ SST

alternative site blood sample collection.

Primary outcome measure

  • Venous and Tasso+ blood sample comparison for ALT [ Time Frame: through study completion, an average of 1 Year and 6 Months ]

Central Contacts and Locations

Central contacts

Locations

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10017

Contacts

Principal Investigator:

James J Harding, MD

EvergreenHealth Research

Recruiting

Kirkland, Washington, United States, 98034

Contacts

Principal Investigator:

Diego Lopez de Castilla, MD

More Information

Sponsor

Tasso Inc.

Last update posted

Feb 28, 2022

Last verified

Feb, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Tasso Inc. on 2022-02-28.