A Multi-Center Study of A New Method of Sweat Testing: The CF Quantum® Sweat Test
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 试验地点
- 6
- 主要终点
- Diagnostic sensitivity and specificity (true positive rate and the false negative rate to measure chloride in the sweat sample) of the new sweat test device compared to the standard-of-care sweat test device
研究概览
简要总结
This is an observational comparative study to compare the standard-of-care methods for sweat testing used to support diagnosing cystic fibrosis (CF) against a new method of sweat testing called the CF Quantum Sweat Test System. The results of the new device in this study are for comparison ONLY and will NOT be used to diagnose, treat or mitigate the subject's condition.
详细描述
The primary objective is to evaluate the diagnostic accuracy of a new sweat test method in both normal individuals and individuals with CF or cystic fibrosis related metabolic syndrome (CRMS).
Subject participation is for one day and duration of study for each subject is one day. No follow-up will be required.
Number of subjects; 300 split evenly between subjects with previously diagnosed CF or CRMS (cystic fibrosis related metabolic syndrome) and subjects referred to the sweat test lab for clinical reasons.
Number of sites = 6, U of WI-Madison, U of WI-Milwaukee, U of MI-Ann Arbor, Dayton Children's Hospital (OH), U of MN, and Children's of Alabama.
Primary endpoints:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients referred to the sweat test lab on a clinical basis.
- •Infants who require a sweat test as follow-up to an abnormal CF screening test.
- •Patients who have already been diagnosed with CF or CRMS.
- •Written informed consent (and assent when applicable) obtained from subject or subject's legal representative.
排除标准
- •Patient is receiving oxygen by open delivery.
- •Infants less than 48 hours of age.
- •Diffuse inflammation or rash on the collection site.
- •Patients who have had a reaction to a prior iontophoretic sweat test procedure.
- •Arm is too small for both the new and conventional sweat test.
结局指标
主要结局
Diagnostic sensitivity and specificity (true positive rate and the false negative rate to measure chloride in the sweat sample) of the new sweat test device compared to the standard-of-care sweat test device
时间窗: Day 1
次要结局
- Compare the sweat test's "quantity not sufficient" (QNS) rate of the new device to the standard-of-care device.(Day 1)