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

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

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

Study Overview

• Status: Recruiting
• Conditions: Elevated Alanine Transaminase (ALT)
• Intervention / Treatment: Other: Tasso+ SST

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Brook Quist; Phone Number: 1004 (206) 822-4186; Email: brook@tassoinc.com

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Not yet recruiting
      • University of Colorado Anschutz Medical Campus
      • Contact: Don Morie; Phone Number: 303-724-7236; Email: don.morie@cuanschutz.edu
      • Principal Investigator: Clayton Smith, MD
  • New York
    • New York, New York, United States, 10017
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Amin Yaqubie; Phone Number: 646-888-4332; Email: yaqubiea@mskcc.org
      • Principal Investigator: James J Harding, MD
  • Washington
    • Kirkland, Washington, United States, 98034
      • Recruiting
      • EvergreenHealth Research
      • Contact: Conner Bentley; Phone Number: 425-899-5385; Email: CCBentley@evergreenhealth.com
      • Principal Investigator: Diego Lopez de Castilla, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with an ALT > 3 X upper limit of normal

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with elevated alanine transaminase (ALT); patients with alanine transaminase (ALT) > 3x upper limit of normal (ULN).	Other: Tasso+ SST; alternative site blood sample collection.; Other Names: Tasso+

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tasso Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: February 16, 2022
• First Submitted That Met QC Criteria: February 24, 2022
• First Posted (Actual): February 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 24, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TALT01-20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No