NCT05849935已完成不适用
A Study to Establish a Reference Range for abioSCOPE® Device With the PSP Assay in a Generally Healthy Adult Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abionic SA
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- To determine the reference range intervals of PSP values measured using abioSCOPE device with the PSP assay in a generally healthy population representative of the US population.
研究概览
简要总结
This is a monocentric, prospective, biomarker-result-blinded observational study evaluating immunoassay measurements of pancreatic stone protein (PSP) performed on Abionic's abioSCOPE device with the PSP assay on generally healthy adults representative of the US population.
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
- 是
入选标准
- •Male or female, aged ≥ 18 years.
- •Apparently healthy as determined by a subject questionnaire.
排除标准
- •Current diagnosis, or history, of any underlying major medical condition determined by the investigator, including but not limited to
- •Renal disease
- •Liver disease
- •Pancreatic disease (including diabetes)
- •Receiving antibiotic therapy
- •Suspected infection
- •Immunosuppression
- •Underwent procedures related to sepsis, or diagnosed with sepsis, within the last 12 months.
- •Current diagnosis of uncontrolled diabetes.
- •Diagnosis of bacterial, fungal, or malaria infection within the last 3 months that required antimicrobial treatment.
- •Experienced severe trauma, surgery, cardiac arrest, or severe burn within the previous 3 months requiring medical care.
- •Diagnosis and/or treatment of cancer within the last 12 months.
- •Received immunosuppressive therapy.
- •Hospitalization for more than 24 hours within the last month.
- •Reported as currently pregnant or nursing a child
- •Unable or unwilling to provide the required blood sample for testing.
结局指标
主要结局
To determine the reference range intervals of PSP values measured using abioSCOPE device with the PSP assay in a generally healthy population representative of the US population.
时间窗: through study completion, an average of 2 months
次要结局
未报告次要终点
研究者
研究点 (1)
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