Status:
UNKNOWN
ALT Routinely Recorded Remotely: A Comparator Study of Liver Function Tests Using the Tasso+ to Venipuncture.
Lead Sponsor:
Tasso Inc.
Conditions:
Elevated Alanine Transaminase (ALT)
Eligibility:
All Genders
18+ years
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 me...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
February 16 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2022
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05259618
Start Date
February 16 2021
End Date
November 1 2022
Last Update
February 28 2022
Active Locations (3)
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1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10017
3
EvergreenHealth Research
Kirkland, Washington, United States, 98034