ALT Routinely Recorded Remotely: A Comparator Study of Liver Function Tests Using the Tasso+ to Venipuncture.
NCT ID: NCT05259618
Last Updated: 2022-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
80 participants
OBSERVATIONAL
2021-02-16
2022-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients with elevated alanine transaminase (ALT)
patients with alanine transaminase (ALT) \> 3x upper limit of normal (ULN).
Tasso+ SST
alternative site blood sample collection.
Interventions
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Tasso+ SST
alternative site blood sample collection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Tasso Inc.
INDUSTRY
Responsible Party
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Locations
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University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
EvergreenHealth Research
Kirkland, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Don Morie
Role: primary
Amin Yaqubie
Role: primary
Conner Bentley
Role: primary
References
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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.
Other Identifiers
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TALT01-20
Identifier Type: -
Identifier Source: org_study_id