Project ARRR, ALT Routinely Recorded Remotely: A Comparator Study of Liver Function Tests Using the Tasso+ to Venipuncture.
试验速览
- 阶段
- 不适用
- 发起方
- Tasso Inc.
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Venous and Tasso+ blood sample comparison for ALT
研究概览
简要总结
A direct comparison study of blood samples collected using the Tasso+ device and venous blood samples in patients with elevated alanine transaminase (ALT).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Venous and Tasso+ blood sample comparison for ALT
时间窗: through study completion, an average of 1 Year and 6 Months
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.
次要结局
- 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)