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

NCT05259618 | Unknown FDA Device

• 1 other identifier: TALT01-20
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 3

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)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Venous and Tasso+ blood sample comparison for additional analytes

  through study completion, an average of 1 Year and 6 Months

• To collect patient experience with the Tasso blood collection

  through study completion, an average of 1 Year and 6 Months

Study Arms (1)

Patients with elevated alanine transaminase (ALT)

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

Other: Tasso+ SST

Interventions

Tasso+ SST OTHER

alternative site blood sample collection.

Also known as: Tasso+

Patients with elevated alanine transaminase (ALT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with an ALT \> 3 X upper limit of normal

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tasso Inc.: lead

Study Sites (3)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

NOT YET RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10017, United States

RECRUITING

EvergreenHealth Research

Kirkland, Washington, 98034, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 36533519 DERIVED

Central Study Contacts

Brook Quist

CONTACT

(206) 822-4186; brook@tassoinc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: February 28, 2022
• Study Start: February 16, 2021
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2022
• Last Updated: February 28, 2022

Record last verified: 2022-02

Locations

US (3)