Novel Point-of-care Sweat Chloride Testing Device for Monitoring CFTR Function
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Sweat Chloride Concentration using the sweat test sensor
研究概览
简要总结
This study is being done to test a device called micro Sweat Test Patch (mSTP or µSTP).
The study team will compare the standard of care (SOC) method of sweat testing with a novel sweat test technique using an integrated micro Sweat Test Patch (µSTP) with microneedle assembly made out of Pilocarpine nitrate, microfluidic channels, and a chloride sensor for point-of-care (POC) measurements of sweat chloride concentrations in newborns being evaluated for cystic fibrosis (CF) diagnosis and in pediatric and adult people with CF (pwCF).
The procedures involve performing a SOC sweat test (if they are not a neonate) and the novel sweat test developed by the research team.
Recruitment for the study will take place at Children's Healthcare of Atlanta and Emory Healthcare cystic fibrosis clinics.
详细描述
The current SOC sweat testing method, using pilocarpine iontophoresis and Macroduct collectors, results in inconsistent sweat production, leading to inadequate collection, delays in CF diagnosis, longer testing times, skin discomfort, and a risk of skin burns. It requires trained personnel and expensive equipment, limiting patient access, and repeating sweat tests after inadequate collection causes delays in starting therapies and stress for parents. In developing countries where CF remains underdiagnosed, access to sweat testing is a major barrier, and the need for refrigeration of the pilogel discs adds cost.
There is an unmet clinical need to improve access to sweat testing worldwide without expensive supplies and laboratory equipment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 2 Weeks 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-90 years old
- •Signed a written informed consent
- •Confirmed CF diagnosis via genetic test or elevated Immunoreactive Trypsinogen (IRT) level in newborn screen
排除标准
- •History of skin disorders (eczema, psoriasis, etc.) that could prevent sweat testing on the forearms
研究组 & 干预措施
Sweat testing using the standard of care
For the SOC method, the forearm will be cleaned with alcohol and then cleaned with deionized (DI) water. The study team will then place two pilocarpine gel discs into the corresponding electrodes and place them on the subject's arm. The SOC method takes 5 minutes to induce sweating using iontophoresis. After sweat has been induced by the SOC method, a sweat collector will be placed on the location of the red electrode to collect the sweat. At the end of the sweat collection period, the sweat collection device will be removed, and the sweat will be extracted from the collection device for analysis in the clinical lab using a chloridometer.
干预措施: Sweat Testing using SOC (Diagnostic Test)
Novel sweat test method
Participants will have the micro Sweat Test Patch (µSTP) placed on the forearm after cleaning with an alcohol pad for 20 minutes. After the stimulation phase, the collection of sweat will be automatically collected by the microfluidics channel on the µSTP, and the sensor will continuously read the sweat chloride value.
干预措施: micro Sweat Test Patch (mSTP) (Device)
结局指标
主要结局
Sweat Chloride Concentration using the sweat test sensor
时间窗: up to 30 minutes post-device placement
Sweat chloride concentration by the µSTP will be assessed and measured using the sweat test sensor.
Sweat Chloride Concentration by SOC
时间窗: up to 45 minutes post-intervention
Sweat chloride concentrations will be measured using the standard-of-care method, using pilocarpine iontophoresis. The collected sweat samples will be sent for analysis of the chloride concentration. The results from the same participant will be compared to the measurements made with the µSTP device.
次要结局
- Visual Erythema Assessment Scale(Immediately after patch removal)
- Pain Score(Up to 2 hours post-intervention)
研究者
Lokesh Guglani
Professor of Pediatrics
Emory University